Contains Nonbinding Recommendations 
 
 
Hydrogen Peroxide-Based Contact 
Lens Care Products: Consumer 
Labeling Recommendations -
Premarket Notification (510(k)) 
Submissions 
______________________________________________________________________________ 
Guidance for Industry and 
Food and Drug Administration Staff 
 
Document issued on July 27, 2023. 
 
The draft of this document was issued on August 17, 2022. 
 
For questions about this document, contact OHT1: Office of Ophthalmic, Anesthesia, 
Respiratory, ENT and Dental Devices/DHT1A: Division of Ophthalmic Devices at (301) 796-
5620.   
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health 
   Contains Nonbinding Recommendations 
 
 
Preface 
 
Public Comment 
 
You may submit electronic comments and suggestions at any time for Agency consideration to 
https://www.regulations.gov. Submit written comments to the Dockets Management Staff, Food 
and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852-
1740. Identify all comments with the docket number FDA-2022-D-0986. Comments may not be 
acted upon by the Agency until the document is next revised or updated. 
 
Additional Copies 
 
Additional copies are available from the Internet.  You may also send an e-mail request to 
CDRH-Guidance@fda.hhs.gov to receive a copy of the guidance. Please include the document 
number GUI00018041 and complete title of the guidance in the request. 
 
  Contains Nonbinding Recommendations 
 
 
Table of Contents 
I.  Introduction ............................................................................................................................... 1 
 
II.  Background ............................................................................................................................... 2 
III. Scope   ...................................................................................................................................... 3 
IV. Specific Consumer Labeling Recommendations ...................................................................... 4 
 General Considerations .......................................................................................................... 4 
 Suggested Format and Content of Consumer Labeling ......................................................... 5 
(1) Package Insert Labeling .................................................................................................... 5 
(2) Carton Labeling ............................................................................................................... 10 
(3) Bottle Labeling ................................................................................................................ 12 
Appendix A: Package Insert Labeling Example ........................................................................... 14 
Appendix B: Carton Labeling Example ........................................................................................ 21 
Appendix C: Bottle Labeling Example ......................................................................................... 23 
 
  Contains Nonbinding Recommendations 
 
 
 
Hydrogen Peroxide-Based Contact 
Lens Care Products: Consumer 
Labeling Recommendations - 
Premarket Notification (510(k)) 
Submissions 
______________________________________________________________________________ 
Guidance for Industry and 
Food and Drug Administration Staff 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA or 
Agency) on this topic.  It does not establish any rights for any person and is not binding on 
FDA or the public.  You can use an alternative approach if it satisfies the requirements of the 
applicable statutes and regulations.  To discuss an alternative approach, contact the FDA staff 
or Office responsible for this guidance as listed on the title page.  
I.  Introduction 
FDA is issuing this guidance to provide labeling recommendations for hydrogen peroxide-based 
contact lens care products (HPCPs) submitted in premarket notification (510(k)) submissions. 
These labeling recommendations are important because misuse associated with these devices has 
resulted in serious eye injuries. FDA believes that the labeling recommendations in this guidance 
may help manufacturers develop labeling with information about specific risks and directions for 
use of the HPCPs in conjunction with a users prescribed contact lenses.  These labeling 
recommendations are intended to promote the safe and effective use of HPCPs and ensure that 
consumers receive and understand information regarding the benefits and risks associated with 
the use of the device.  
 
In general, FDAs guidance documents do not establish legally enforceable responsibilities. 
Instead, guidances describe the Agencys current thinking on a topic and should be viewed only 
as recommendations, unless specific regulatory or statutory requirements are cited. The use of 
the word should in Agency guidances means that something is suggested or recommended, but 
not required. 
 
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  Contains Nonbinding Recommendations 
 
 
II.  Background 
Hydrogen peroxide-based contact lens care product solutions, as well as other multipurpose 
solutions, both clean and disinfect contact lenses by breaking up and helping to remove trapped 
debris, protein, fatty deposits, and microorganisms. Unlike other multipurpose solutions, 
hydrogen peroxide-based contact lens care product solutions are generally preservative-free, 
which makes them a suitable option for those who are allergic or sensitive to the preservatives 
found in multipurpose solutions. They are not risk-free, however, and should be used by 
following appropriate labeling considerations.1 Consumers should be aware of these 
considerations prior to choosing, and while using, this type of medical device.  
 
To implement section 520(l) of the Federal Food, Drug, and Cosmetic (FD&C) Act, which 
contains specific provisions on transitional devices (i.e., those devices regulated as drugs before 
the Medical Device Amendments of 1976 became law), FDA published a rule proposing to 
reclassify HPCPs from class III (premarket approval) to class II (special controls).2 The final rule 
reclassifying HPCPs was published on June 6, 1997,3 amending 21 CFR 886.5918 and 21 CFR 
886.5928 to classify rigid gas permeable contact lens care products and soft contact lens care 
products as class II, respectively. FDA also issued a guidance document, Premarket Notification 
(510(k)) Guidance Document for Contact Lens Care Products,4 and a subsequent addendum 
Contact Lens Care Products Labeling.5 These documents include details regarding, among 
other things, the labeling of contact lens care products. 
 
The safety and effectiveness of HPCPs when used as directed has been well established in the 
last few decades; however, FDA has become aware of an increase in the number of adverse 
event reports related to the misuse of these products. Consumers have reported adverse events 
ranging from irritation to severe burning and stinging of the eyes and even blindness with the use 
of HPCPs. The reports received to date indicate that the packaging is not easily distinguishable 
from other lens care products, which FDA believes has likely resulted in improper use. FDA 
convened a meeting of the Ophthalmic Devices Panel of the Medical Devices Advisory 
Committee and the Risk Communication Advisory Committee on March 17, 2017, to discuss 
additional measures to mitigate the potential risk for misuse of these devices.6  While the rate of 
adverse events reported to the FDA is relatively low compared to the estimated number of HPCP 
users, the number of reports likely underestimate the actual occurrence of such events. The 
meeting covered a range of important issues, including appropriate labeling and packaging of 
these products, and the importance of clearly communicating the risks of misuse to the consumer 
 
1 For further information on hydrogen peroxide-based contact lens care products, see  
https://www.fda.gov/medical-devices/contact-lenses/hydrogen-peroxide-solution.  
2 See 61 FR 14277 (April 1, 1996). With the enactment of the Medical Device Amendments of 1976, transitional 
devices were classified in class III by operation of the statute, unless later classified by FDA in class I or II. See 
FD&C Act  520(l)(1). 
3 See 62 FR 30985.   
4 https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-
products/contact-lens-care-products-premarket-notification-510k-guidance. 
5 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/contact-lens-care-products-labeling.  
6 March 17, 2017 Meeting: Ophthalmic Devices Panel for the Medical Devices Advisory Committee and the Risk 
Communication Advisory Committee (available at https://www.fda.gov/advisory-committees/ophthalmic-devices-
panel/2017-meeting-materials-ophthalmic-devices-panel). 
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  Contains Nonbinding Recommendations 
 
 
public. The Panel emphasized a need for simplicity and clear messaging in terms of warnings 
and instructions for use, in addition to the ability to identify the bottles by utilizing a red tip and 
red cap as already used on most HPCP solutions. The Panel also recommended a redesign and 
standardization of the labeling so that it is different from other contact lens care products. In light 
of the well-documented low compliance rate among consumers with recommended lens care 
practices,7 as well as the reasons outlined above, FDA is providing recommendations concerning 
the content and format of labeling for these devices. FDA believes the labeling content and 
format recommended in this guidance provides at least the same level of protection of the public 
health and safety as the labeling details contained in Premarket Notification (510(k)) Guidance 
Document for Contact Lens Care Products8 and its addendum Contact Lens Care Products 
Labeling.9  
III.  Scope 
This guidance document applies to all HPCPs. These devices are classified under 21 CFR 
886.5918 and 21 CFR 886.5928 with the product codes listed in the table below: 
 
Table 1: Applicable Product Codes 
Product Code  Product Code Name  Regulation Number 
MRC  Products, Contact Lens Care, Rigid Gas  21 CFR 886.5918 
Permeable 
LPN  Accessories, Soft Lens Products  21 CFR 886.5928 
 
Although not in the scope of this guidance, the Panel also suggested making a change in the 
bottle shape, size, color, tactile features or other characteristics that would distinguish HPCPs 
from other contact lens care products that do not contain hydrogen peroxide. While FDA does 
not intend to recommend the type of bottle to be used to contain HPCP solutions, FDA 
recommends, to the extent possible, containers should appear distinct from those of multipurpose 
solutions or other products without hydrogen peroxide, which could minimize potential product 
selection errors and product misuse.  
 
Based on the adverse event reports and feedback obtained during the March 2017 Panel Meeting, 
device misuse may be exacerbated if the directions for use and warnings or precautions in the 
device labeling are not clear. FDA believes that these problems can be mitigated by emphasizing 
and simplifying important warnings and directions for use on the bottle and carton labeling for 
HPCP solutions. The inclusion of such information should also be helpful in developing labeling 
with adequate information for use under 21 CFR 801.5. For example, FDA believes the 
appropriate design and standardization of labeling would help inform consumers of device risks, 
thereby increasing the likelihood of appropriate device use and helping to mitigate against device 
misuse.  
 
 
7 Ky W, Scherick K, Stenson S. Clinical survey of lens care in contact lens patients. CLAO J. 1998 Oct;24(4):216-9. 
8 https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-
products/contact-lens-care-products-premarket-notification-510k-guidance. 
9 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/contact-lens-care-products-labeling. 
3 
  Contains Nonbinding Recommendations 
 
 
Since these recommendations are based on known safety issues, FDA recommends that this 
information be considered for inclusion as current product labeling is updated, and that labeling 
included as part of future premarket submissions for HPCPs incorporate the recommendations. 
For currently marketed HPCPs, manufacturers should evaluate their labeling changes according 
to FDAs guidance, Deciding When to Submit a 510(k) for a Change to an Existing Device.10  
 
This guidance is not intended to include a complete listing of all labeling components for 
HPCPs. This guidance should be used as a complement to FDAs Guidance on Medical Device 
Patient Labeling,11 (hereafter referred to as the Patient Labeling guidance, which describes 
FDAs current thinking on making medical device patient labeling understandable to and usable 
by patients), existing regulations, and other relevant guidance documents containing additional 
labeling recommendations. This guidance also complements FDAs guidance Premarket 
Notification (510(k)) Guidance Document for Contact Lens Care Products12 and its addendum 
Contact Lens Care Products Labeling.13 This guidance provides recommendations that are 
specific to HPCPs and may assist in complying with some special controls.  
IV.  Specific Consumer Labeling Recommendations 
 General Considerations 
Contact lens care products, including HPCPs, are subject to the general labeling requirements for 
all medical devices outlined in 21 CFR 801. The premarket notification submission must include 
proposed labeling in sufficient detail to satisfy the requirements of 21 CFR 807.87(e). Consumer 
labeling for HPCPs includes information contained on the package insert, carton, and bottle, and 
is directed to the contact lens wearer. The consumer labeling for HPCPs should instruct the 
consumer on product care to ensure contact lenses are used safely and effectively, to identify 
potential risks and benefits, and to explain what to expect when these care products are used. The 
labeling should contain sufficient information to describe the device, its intended use, 
precautions, warnings, and contraindications. 
 
Consumer labeling should be written in simple, plain language that does not exceed the eighth-
grade reading level. Regardless of the reading level, poorly designed text can still be confusing 
and misleading. The consumer labeling should be directed to users and potential consumers of 
HPCPs and should address the following questions: 
 
  How do Hydrogen Peroxide-Based Contact Lens Care Products work? 
  How should I use Hydrogen Peroxide-Based Contact Lens Care Products correctly? 
  What are the risks associated with Hydrogen Peroxide-Based Contact Lens Care 
Product use? 
 
10 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-change-
existing-device.  
11 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-medical-device-patient-
labeling. 
12 https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-
products/contact-lens-care-products-premarket-notification-510k-guidance. 
13 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/contact-lens-care-products-labeling. 
4 
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  Who should I contact if there is a problem? 
 
The lay language should provide a balanced presentation of adverse events and the risks and 
benefits of the device. It should not introduce implied or actual statements regarding performance 
that are unsubstantiated or that may be misleading to consumers. In order to increase the 
likelihood that the consumer labeling is read and understood by the consumer, we recommend 
that manufacturers consider placing consumer labeling on their website to help consumers obtain 
the most up-to-date information. 
 
We recommend that consumer labeling contain the information in the sections outlined in the 
Patient Labeling guidance. The sections suggested in the Patient Labeling guidance may be 
adapted as appropriate for HPCPs and should enable the consumer to easily find and understand 
information that answers the questions identified above. The recommendations in this guidance 
are intended to supplement and enhance the information that is often already identified in 
labeling for these device types. To the extent the recommendations in this document depart from 
previously issued recommendations in the 2010 guidance, Contact Lens Care Products 
Labeling,14 this document supersedes those previous recommendations as applied to hydrogen 
peroxide-based contact lens care products under product codes MRC and LPN. This guidance 
presents FDAs format and content recommendations for specific labeling components, and FDA 
has provided examples of each in the appendices to help illustrate the recommendations. 
Alternative approaches may be appropriate where they remain aligned with the intent of 
promoting the safe and effective use of HPCPs.   
 Suggested Format and Content of Consumer Labeling 
(1) Package Insert Labeling 
To help manufacturers develop appropriate labeling and to mitigate the safety issues related to 
HPCP misuse, FDA is providing the following recommendations for the package insert labeling. 
The package insert should include the following information where applicable.  An example of 
package insert labeling is provided in Appendix A. 
 
a. General Instructions and Description 
FDA believes that the package insert should include general instructions and description as 
outlined below:  
 
  A section that describes the general process involved with the use of HPCPs including: a 
description of the disinfecting and neutralization process, and whether it is a one-step or 
two-step process. 
  A statement to read the instructions carefully and to retain the information for future use. 
  The trade name and identification of the active ingredient(s) (optional, list of inactive 
ingredients), sterility status, and when applicable, a description of the contents (e.g., case, 
disk or tablet) and any additional components. FDA believes that prominent text 
 
14 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/contact-lens-care-products-labeling. 
5 
  Contains Nonbinding Recommendations 
 
 
identifying that the product contains 3% hydrogen peroxide should be included in this 
section. 
  A description of the function of the device (i.e., how the device works in relation to the 
contact lenses). When applicable, the actions may also be listed with the indications for 
use. 
  The indications for use statement as described in the submission. 
 
b. Contraindications 
Contraindications describe situations in which the device should not be used because the risk of 
use of the device clearly outweighs any reasonably foreseeable benefit. FDA recommends that 
manufacturers include all contraindications specific to the device.  For example, such 
contraindications may include a statement identifying that the device should not be used if 
allergic to any ingredient in the device. If there are no contraindications, a statement may be 
provided noting that there are no known contraindications.   
 
c. Warnings 
FDA recommends that manufacturers prominently display (e.g., using emphasized text) 
appropriate warnings regarding how to avoid known hazards associated with the use of HPCPs. 
These warnings may alert consumers to the possibility of serious adverse reactions, situations 
which, if not avoided, could result in death or serious injury, and steps that should be taken if 
they occur. FDA believes such warnings include the following examples of (1) general warnings   
and (2) additional warnings. 
 
General Warnings 
FDA believes general warnings should include the following information: 
 
  A statement that the solution should only be used with the case provided and warn 
against the use of flat lens cases. 
  A statement identifying the minimum time to ensure the completion of the neutralization 
process prior to lens insertion and a statement that unneutralized disinfecting solution 
should not be put into the eye.  
  Directions for when unneutralized solution does come in contact with the eyes. 
  A statement that warns against the reuse of the neutralized HPCP solutions. 
  A statement that warns against rinsing your lenses with the HPCP solution prior to 
insertion, which would cause severe burning or stinging. 
  A statement that warns against directly squirting the HPCP solution into the eyes and 
against use as an on-eye lens rewetting solution. 
 
The statements above, wherever possible, should also warn consumers of the risks associated 
with putting HPCP solution into the eye directly or indirectly (e.g., severe burning and stinging). 
 
Additional Warnings 
FDA recommends that manufacturers include warnings emphasizing that it is essential for 
consumers to follow all labeling instructions for proper use of contact lenses and lens care 
products. FDA recommends such additional warnings include the following instructions for use 
and warnings pertaining to contact lens wear:  
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  Contains Nonbinding Recommendations 
 
 
 
  A statement warning against reuse or topping off solutions. Reuse may reduce effective 
lens disinfection and could lead to severe infection, vision loss, or blindness. Topping 
off is the addition of fresh solution to solution that has been sitting in the lens case. A 
statement referencing the use of fresh, sterile or unexpired solution each time you use 
your contact lenses should be included. Graphics warning against reuse or topping off of 
solution are also recommended. 
  A statement against storing your lenses or rinsing your lens case with water or any non-
sterile or expired saline solution (e.g., these practices may lead to ocular infections). 
  A statement that warns against risks associated with contact lens exposure to water from 
showering, swimming in pools, lakes, or oceans (e.g., may harbor microorganisms that 
lead to severe infection, vision loss, or blindness). 
  A statement that warns against using inappropriate liquids to disinfect your lenses, since 
not using the recommended disinfectant may lead to severe infection, vision loss or 
blindness. 
  A statement that warns of the risks associated with using solutions past their discard date 
since the performance of solutions have not been tested past their discard date. The 
discard date refers to the time you can safely use the contact lens care product after the 
bottle has been opened. It is not the same as the shelf-life/expiration date, which is the 
last date that the product is still effective before it is opened. 
  A statement that warns of the potential contamination of the solution, which may reduce 
the effectiveness of solutions and result in contamination of lenses (e.g., avoid touching 
surfaces or transferring solutions). 
  A statement that warns of the risks associated with ingestion of hydrogen peroxide, which 
may occur if small children have access to the product.  A statement should be added 
advising consumers to seek immediate medical attention if ingested and/or promptly 
contact their eye care practitioner.  
  When applicable, a statement that warns of possible effects associated with rubbing rigid 
gas permeable (RGP) lenses with peroxide solution (e.g., that may result in skin 
discoloration). A statement should be added advising consumers to wash and rinse their 
hands after rubbing RGP lenses. 
  When applicable, a statement that warns against ingestion of neutralizing tablets that may 
result in upset stomach and vomiting. A statement should be added advising consumers 
not to ingest tablets and to seek immediate medical attention if ingested and/or promptly 
seek medical assistance or a poison control center.  
  When applicable, statements against improper use of neutralization tablets that may result 
in inadequate neutralization. Statements should be added advising consumers of 
situations that may result in inadequate neutralization or disinfection (e.g., crushing a 
neutralizing tablet, number of times a neutralizer disk may be used). 
 
Non-Product Specific Warning 
Additionally, FDA recommends that manufacturers include a non-product specific warning that 
specifies that consumers should follow the directions of the eye care practitioner and all labeling 
instructions for proper use and care of both their lenses and lens care products, including the lens 
case since problems with contact lenses and lens care products could result in serious injury to 
the eye. FDA recommends that this warning also include the following information: 
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  Contains Nonbinding Recommendations 
 
 
  Specifying that daily wear lenses are not indicated for overnight wear and that clinical 
studies have shown that there is an increased risk for serious adverse reactions when 
worn overnight.  
  Specifying that extended wear lenses should be regularly removed for cleaning and 
disinfection or disposal and replacement as prescribed by the eye care practitioner, and 
that clinical studies have shown that there is an increased incidence of serious adverse 
reaction in extended wear contact lens wearers compared to daily wear contact lens 
wearers. Studies have also shown that the risk of serious adverse reactions increases the 
longer extended wear lenses are worn before removal for cleaning and disinfection or for 
disposal and replacement. 
  Specifying that studies have also shown that smokers who wear contact lenses have a 
higher incidence of adverse reactions. 
  Specifying that if the consumer experiences eye discomfort, excessive tearing, vision 
changes, or redness of the eye, that they should remove their contact lenses and contact 
their eye care practitioner. 
 
d. Precautions 
FDA recommends that precautions include information for the safe and effective use of the 
device by the consumer to mitigate minor or moderate injury. Listed below are examples of 
general precautions that pertain to all HPCP solutions and specific precautions for neutralizing 
products. FDA believes such precautions include the following: 
 
General Precautions 
  A statement that consumers should always wash and dry their hands prior to 
manipulating lenses because residual dirt, oils, and/or contamination may result in 
subsequent stinging or ocular infection.  
  A statement that consumers should never use generic hydrogen peroxide not specifically 
intended for use with contact lenses or mix HPCP solutions because this may result in 
insufficient disinfection, neutralization, and/or damage to contact lenses.  
  Statements that consumers should never reuse solutions, should always use fresh, 
unexpired solution, and should never store lenses in used neutralized solution for longer 
than stated in the directions for use because this will help ensure sufficient disinfection 
and avoid subsequent contamination. 
  Statements regarding activities during or after use of HPCP solutions that may reduce the 
product effectiveness, enhance deterioration and/or cause lens damage. These activities 
may include: shaking/inverting the lens case during disinfection, failure to discard the 
contents of the bottle X months after first opening, failure to keep the bottle closed 
when not in use, failure to store the bottle at a certain temperature and/or range, failure to 
keep the lenses immersed in the storage solution when not worn; and heating the solution 
or contact lenses. 
 
Precautions for Neutralizing Products 
FDA recommends the inclusion of statements regarding activities during or after use of 
neutralizing tablets that may reduce the product effectiveness, enhance deterioration and/or cause 
lens damage. These activities may include: using tablets that appear to be broken, chipped, or 
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  Contains Nonbinding Recommendations 
 
 
discolored; using tablets from packages that are torn or punctured; substituting neutralizing 
components; and using neutralizing tablets in a heat disinfection unit. 
 
e. Adverse Reactions  
FDA recommends that the package insert labeling should inform consumers about the potential 
adverse reactions associated with the use of the product and that eye problems, including corneal 
ulcers, can develop rapidly and lead to loss of vision. The package insert labeling should also 
include a statement that if a consumer notices any adverse reactions (e.g., stinging and burning, 
eye discomfort, excessive tearing, among others), they should immediately remove lenses. 
Statements should be added to the package insert advising the consumer on instructions for lens 
removal thereby reducing the potential for ocular damage. The package insert labeling should 
also include statements that consumers immediately contact their eye care practitioner if 
problems persist or worsen, to seek immediate professional care, and to report all adverse events 
to the manufacturer. A statement should be added to inform the consumer that they can also 
report adverse events to FDA Medwatch. This is important to diagnose or document any adverse 
events associated with the product.  
 
f. General Directions for Use 
FDA recommends all directions for use contain the major steps of the process (e.g., rinse with 
solution, fill provided container, and soak) to ensure proper use of HPCP solutions. Each step 
should be briefly described using simple language for easy understanding. The use of graphics in 
device labeling has been shown to contribute to better comprehension.15 As such, FDA 
recommends that simple graphics, where appropriate, should be included.  In order to provide a 
complete set of directions for consumers, FDA recommends that these directions include the 
following: 
  Instructions for safe handling of contact lenses to minimize residual dirt, oils, and/or 
contamination, which may result in subsequent stinging or ocular infection. 
  Specific, detailed directions based on the lens type (e.g., soft and RGP lenses) to convey 
important differences in the cleaning/disinfection regimen. FDA recommends 
reemphasizing warning statements regarding not putting HPCP solution into the eye 
because unneutralized hydrogen peroxide exposure may result in corneal burns, redness 
and stinging (see Appendix A for examples for soft lenses and for RGP lenses). 
  Information for lens case care and replacement. This is important to ensure that users 
appropriately clean and care for the lens case as they have been shown to be a source of 
microbial contamination. 
  Information regarding how the product is supplied (e.g., sterile, quantity of contents, type 
of packaging, lot number), distributor/manufacturer name and address, and the date the 
labeling was printed. This is important to allow traceability and identification for adverse 
event reporting or for consumer questions. 
 
15 Kools M, van de Wiel MW, Ruiter RA, Kok G. Pictures and text in instructions for medical devices: effects on 
recall and actual performance. Patient Educ Couns. 2006 Dec;64(1-3):104-11. Epub 2006 Feb 10. 
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(2) Carton Labeling 
In order to highlight warnings, precautions, and to minimize crowding, FDA recommends that the 
directions for use should not be included in carton labeling. However, a statement should be 
added directing users to follow directions on the bottle and in the package insert. FDA also 
recommends that the carton labeling contain a prominent red banner (e.g., at least 1 inch in 
height where possible) encircling the top of the carton that includes text emphasizing that the 
HPCP solution should not be put into the eyes. We also recommend that manufacturers include 
two identical statements, such as DO NOT PUT IN EYES or similar statement, that span the 
circumference of the carton with associated graphics, in emphasized font. The banner should be 
similar to the banner placed on the bottle. FDA recommends a minimalist approach to the content 
of the carton labeling and font sizes consistent with the Patient Labeling guidance, which aligns 
with 2017 Panel recommendations. An example of carton labeling is provided in Appendix B. 
 
a. Manufacturer and Product Information 
HPCPs are over-the-counter devices and labeling must comply with 21 CFR 801.60 - Principal 
display panel, as well as 21 CFR 801.61 - Statement of identity and 21 CFR 801.62 - Declaration 
of net quantity of contents. In addition, the labeling must comply with 21 CFR 800.12  Contact 
lens solutions and tablets; tamper-resistant packaging, and 21 CFR 800.10  Contact lens 
solutions; sterility, and should also contain the following recommended information:  
 
Principal Display Panel (see 21 CFR 801.60): 
  Product Trade Name [including emphasis on 3% Hydrogen Peroxide [Solution] 
(e.g., in prominent text)] (see Patient Labeling guidance for recommendations on 
font sizes for Headings) 
  Actions and Indications (see 21 CFR 801.61; e.g., cleans, disinfects) 
  Lens Compatibility (i.e., the type of lenses for which the device may be used) 
  Net Quantity Contents (21 CFR 801.62) 
  Sterile 
 
Outer Carton Panels 
  Special Storage Conditions (e.g., store at room temperature) 
  A statement referring customers to the bottle and package insert for information on 
proper use of the product 
  Tamper-Resistant Statement (21 CFR 800.12) 
  A statement to keep product out of the reach of children 
  [Insert information on whom to contact for concerns, adverse reactions, and 
additional information: [Distributed by/Manufactured by/Manufactured for] Address 
including zip code, website, and phone number.]  
  Lot Number 
  Expiration Date 
  Product Information: 
  Description (i.e., Active Ingredients) 
o
  Package contents (e.g., a lens case is included) 
o
  A statement referring customers to consult the package insert for complete safety 
information 
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  Website and social media connections (e.g., Quick Response (QR) code, website 
link) to manufacturers and FDA (e.g., Hydrogen Peroxide Solution 
https://www.fda.gov/medical-devices/contact-lenses/hydrogen-peroxide-solution)  
 
b. Contraindications  
FDA recommends that the same contraindications that are included in the package insert labeling 
as outlined in Section IV.B.1.b of this guidance also be included on the carton labeling.  
 
c. Warnings 
To minimize overcrowding, FDA recommends that manufacturers include only those warning 
statements in the carton labeling that inform the consumers of the risks associated with HPCP 
solution that is not neutralized. This is important because unneutralized hydrogen peroxide 
exposure may result in corneal burns, redness and stinging. Statements using emphasized text 
(e.g., red and bold text) should be added to the warnings section on the carton to highlight these 
concerns, but bold text should be limited to emphasize key details only. In addition, FDA 
recommends that consumers be referred to the package insert for a complete list of warnings.  
Manufacturers should include the following statements/warnings with associated graphics on the 
carton labeling to inform consumers of the risks associated with unneutralized hydrogen 
peroxide: 
 
  A statement that the solution should only be used with the case provided and warn 
against the use of flat lens cases. 
  A statement identifying the minimum time to ensure the completion of the neutralization 
process prior to lens insertion. 
  A statement that warns against rinsing your lenses with the HPCP solution just prior to 
insertion, which would cause severe burning or stinging. 
  A statement that warns against directly squirting the HPCP solution into the eyes and 
against use as an on-eye lens rewetting solution. 
  The statements above, wherever possible, should also warn the consumer of the risks 
associated with inserting HPCP solution into the eye (e.g., severe burning and stinging). 
  A statement that the product contains hydrogen peroxide and that users should follow all 
directions on the bottle and in the package insert to avoid injury. 
 
Since most non-hydrogen peroxide contact lens care products are used with flat lens cases that 
do not neutralize hydrogen peroxide, consumers may be confused regarding the need for the 
special neutralizing case provided with HPCP solutions. Therefore, to increase the likelihood that 
consumers understand these risks, and to emphasize the need for the neutralization of hydrogen 
peroxide, FDA recommends manufacturers include additional warnings, including graphics, 
against the use of flat lens cases on the top left and right carton flaps (in emphasized text), in 
addition to the body of the carton labeling. This labeling recommendation is consistent with the 
2017 Panel recommendations, which advised graphics on the opening flap of the box since this 
warning is the first message consumers encounter as they open the product.  
 
11 
  Contains Nonbinding Recommendations 
 
 
d. Precautions 
FDA recommends that carton labeling only include precautions for the safe use of the device by 
the user to mitigate minor or moderate injury. These may include precautions that warn against 
the use of generic hydrogen peroxide or activities that may result in inadequate neutralization of 
hydrogen peroxide prior to use.  FDA recommends that manufacturers should include a 
statement that refers consumers to the package insert for a complete list of precautions.  
(3) Bottle Labeling 
To help manufacturers develop bottle labeling that is clear, simple and consistent across products 
and to help mitigate the safety issues for HPCPs, FDA is providing the following labeling 
recommendations, which also align with recommendations provided at the 2017 Panel Meeting. 
FDA recommends that the bottles design include a red cap and red tip as an indication that the 
solution should not be instilled directly into the eyes.16,17 FDA recommends that bottle labeling 
consist of three equal-sized panels with a prominent red banner (e.g., at least 1 inch in height 
where possible) encircling the top of the bottle that includes text emphasizing that the HPCP 
solution should not be put into the eyes. We recommend manufacturers include two identical 
statements such as DO NOT PUT IN EYES or similar statement, in emphasized font that span 
the circumference of the bottle with associated large graphics (e.g., an image of bottle squirting 
in the eye crossed out). The red banner on the bottle labeling should be consistent with the 
banner on the carton labeling. Please see Appendix C for an example of the bottle labeling.   
To minimize overcrowding, the bottle label should include the minimum information needed for 
consumers to safely use the product and include the product information, directions for use, and 
warnings. The labeling text should be written using clear, simple and concise language. FDA 
recommends font sizes consistent with the Patient Labeling guidance. FDA recommends the 
bottle labeling contain the following information: 
a. Manufacturer and Product Information 
  Distributers/Manufacturers name and address including zip code, phone number  
  Lot Number  
  Expiration Date  
  Date Opened ____/or Discard Date_____ 
  Product Trade Name 
  Description (i.e., Active Ingredients), including emphasis on 3% Hydrogen Peroxide 
[Solution] (e.g., in prominent text) located near the Product Trade Name (see Patient 
Labeling guidance for recommendations on font sizes for Headings) 
  Actions and Indications (see 21 CFR 801.61; e.g., cleans, disinfects, etc.)  
  Lens Compatibility (i.e., the type of lenses that the HPCP can be used with) 
  Net Quantity Contents (21 CFR 801.62) 
  Sterile 
 
16 March 17, 2017 Meeting: Ophthalmic Devices Panel for the Medical Devices Advisory Committee and the Risk 
Communication Advisory Committee (available at https://www.fda.gov/advisory-committees/ophthalmic-devices-
panel/2017-meeting-materials-ophthalmic-devices-panel). 
17 For further information on hydrogen peroxide-based contact lens care products, see  
https://www.fda.gov/medical-devices/contact-lenses/hydrogen-peroxide-solution. 
12 
  Contains Nonbinding Recommendations 
 
 
  Special Storage Conditions (e.g., store at room temperature) 
  A statement advising users to keep out of reach of children 
  A statement referring customers to consult the package insert for complete safety 
information 
  Website and social media connections (e.g., Quick Response (QR) code, website link) to  
manufacturers and FDA (e.g., Hydrogen Peroxide Solution 
https://www.fda.gov/medical-devices/contact-lenses/hydrogen-peroxide-solution)  
 
b. Directions for Use 
The directions for use should contain the major steps of the process (e.g., rinse with solution, fill 
provided container, and soak) as referenced in the package insert. Each step should be briefly 
described using simple language for easy understanding. Simple graphics, where appropriate, 
should be included to aid in understanding.  
 
c. Contraindications  
FDA recommends that all known contraindications specific to the device be included on the 
bottle labeling as identified in the package insert section IV.B.1.b of this guidance.  
 
d. Warnings 
To minimize overcrowding, FDA recommends that manufacturers only include warning 
statements that inform the consumer of the risks associated with unneutralized HPCP solution 
(e.g., severe burning and stinging) on the bottle labeling. As noted previously, this is important 
because unneutralized hydrogen peroxide exposure may result in corneal burns, redness and 
stinging. Statements using emphasized text (e.g., red and bold text) should be added to the 
warnings section to highlight these concerns and any key details. In addition, clear warnings with 
associated graphics should be added to aid in understanding of how consumers may be exposed 
to unneutralized hydrogen peroxide. Manufacturers should include the following: 
 
  A statement that the solution should only be used with the case provided and warn 
against the use of flat lens cases. 
  A statement identifying the minimum time to ensure the completion of the neutralization 
process prior to lens insertion. 
  A statement that warns against rinsing your lenses with the HPCP solution just prior to 
insertion, which would cause severe burning or stinging. 
  A statement that warns against squirting the HPCP solution into the eyes. 
  The statements above, wherever possible, should also warn the consumer of the risks 
associated with inserting HPCP solution into the eye (e.g., severe burning and stinging). 
 
   
13 
  Contains Nonbinding Recommendations 
 
 
Appendix A: Package Insert Labeling Example 
 
This section provides an example of a package insert for an HPCP, as described in Section 
IV.B.1.  
 
 
GENERAL 
Hydrogen peroxide placed directly into the eyes or onto contact lenses prior to insertion 
can cause stinging, burning, and corneal damage. When using hydrogen peroxide, the 
disinfecting process must be followed with neutralization. The neutralization of hydrogen 
peroxide into water and oxygen makes it safe to put your lenses back into the eyes. 
Neutralization can be either a one-step or two-step process. The one-step process 
neutralizes the lenses during the disinfecting stage, while the two-step process neutralizes 
the lenses after the disinfecting stage. 
Some storage cases have a neutralizer built-in, making it a simple one-step process. With 
other cases, a neutralizing tablet that comes with the hydrogen peroxide-based contact 
lens care product solution must be added. This is the two-step process. 
IMPORTANT - Please read carefully and keep this information for future use.   
 
TRADE NAME 
[TRADENAME (TN)] 
3% Hydrogen Peroxide Solution 
 
DESCRIPTION/CONTENTS: 
[Include "sterile;" list active ingredients (optional, list inactive ingredients). When 
applicable, include the following additional descriptive information: 
 
Case, Disk, or Tablet, and describe each item and any additional components] 
 
ACTIONS: 
[Include a concise description of the function of the device (i.e., how the device works in 
relation to the contact lens). When applicable, the actions can be listed with the 
indications (i.e., INDICATIONS/ACTIONS).] 
 
INDICATIONS (USES): 
[Include the Indication for Use Statement as described in the marketing submission.] 
 
CONTRAINDICATIONS: 
  [Include all known contraindications.  If there are no known contraindications, add 
the statement There are no known contraindications for use of this product.] 
  If you are allergic to any ingredient in this device, DO NOT USE. 
 
GENERAL WARNINGS: 
14 
  Contains Nonbinding Recommendations 
 
 
  [TN] Solution is neutralized only with the special [TN] Solution case. NEVER 
use a flat lens case. It will cause severe burning and stinging! 
  NEVER soak lenses in [TN] Solution for less than [X] hours to ensure 
completion of the neutralization process prior to lens insertion. It may cause 
severe burning and stinging. DO NOT PUT [TN] DISINFECTING SOLUTION 
THAT HAS NOT BEEN NEUTRALIZED IN YOUR EYE. Should 
unneutralized [TN] solution get in your eye, remove your lenses immediately, 
flush (wash) your eyes with a large amount of water or sterile saline for a few 
minutes. If burning and/or irritation persist, seek assistance from an eye care 
professional.  
  DO NOT REUSE NEUTRALIZED HYDROGEN PEROXIDE SOLUTION. 
  NEVER rinse your lenses with [TN] Solution and put them in your eyes! It will 
cause severe burning and stinging! 
  The red dropper tip indicates that [TN] solution should not be put directly or 
indirectly in your eye. NEVER squirt [TN] Solution into your eyes or use as an 
on-eye lens rewetting solution! It will cause severe burning and stinging! 
ADDITIONAL WARNINGS: 
  You should not reuse or top off old solution left in your lens case since solution 
reuse reduces effective lens disinfection and could lead to severe infection, vision 
loss, or blindness. Topping off is the addition of fresh solution to solution that has 
been sitting in the lens case. 
  Do not store your lenses or rinse your lens case with water or any non-sterile or 
expired saline solution. Use fresh, sterile or unexpired saline solution so you do not 
contaminate your lenses or lens case. Use of non-sterile or expired solution can lead 
to severe infection, vision loss, or blindness. 
  Water can harbor microorganisms that can lead to severe infection, vision loss, or 
blindness. If the contact lenses have been exposed to water, such as when showering, 
swimming in pools, lakes, or oceans, you should discard them and replace them with 
a new pair. You should ask your eye care professional for recommendations about 
wearing your lenses during any activity involving water. 
  Never use water, saline solution, or rewetting drops to disinfect your lenses. These 
solutions will not disinfect your lenses. Not using the recommended disinfectant can 
lead to severe infection, vision loss or blindness.  
  Using peroxide solutions beyond the discard date could result in contamination of the 
solution and can lead to severe infection, vision loss, or blindness. 
  To avoid contamination, DO NOT touch tip of container to any surface. Replace cap 
after using. 
  To avoid contaminating your solution, DO NOT transfer to other bottles or 
containers. 
15 
  Contains Nonbinding Recommendations 
 
 
  Keep out of the reach of children. If accidentally swallowed, an upset stomach and 
vomiting may result. Seek immediate professional medical assistance or contact a 
poison control center. 
  While rubbing RGP lenses with [TN] solution, some consumers may experience a 
mild, temporary skin discoloration (bleaching) of the fingers or hands. Always wash 
and rinse your hands after rubbing your lenses with the solution. 
  [When applicable] This tablet is not to be taken internally. If accidentally swallowed, 
an upset stomach and vomiting may result. Seek immediate professional medical 
assistance or contact a poison control center. 
  [When applicable] DO NOT crush the [TN] Neutralizing Tablet. If a crack occurs in 
the coating, the tablet may begin to neutralize the [TN] Disinfecting Solution before 
adequate disinfection occurs. 
  [When applicable] DO NOT use [TN] Neutralizer disk for more than [X] uses or [X] 
months of daily use. [Note:  Uses and time period should be determined by testing 
data.] 
  PROBLEMS WITH CONTACT LENSES AND LENS CARE PRODUCTS COULD 
RESULT IN SERIOUS INJURY TO THE EYE. Follow your eye care practitioner's 
directions and all labeling instructions for proper use and care of your lenses and lens 
care products, including the lens case. Eye problems, including corneal ulcers, can 
develop rapidly and lead to loss of vision. Daily wear lenses are not indicated for 
overnight wear and should not be worn while sleeping. Clinical studies have shown 
the risk of serious adverse reactions is increased when these lenses are worn 
overnight. Extended wear lenses should be regularly removed for cleaning and 
disinfection or for disposal and replacement on the schedule prescribed by your eye 
care practitioner. Clinical studies have shown that there is an increased incidence of 
serious adverse reactions in extended wear contact lens users as compared to daily 
wear contact lens users. Studies have also shown that the risk of serious adverse 
reactions increases the longer extended wear lenses are worn before removal for 
cleaning and disinfection or for disposal and replacement. Studies have also shown 
that smokers who wear contact lenses have a higher incidence of adverse reactions. If 
you experience eye discomfort, excessive tearing, vision changes, or redness of the 
eye, immediately remove your lenses and promptly contact your eye care practitioner. 
All contact lens wearers should see their eye care practitioner as directed. 
 
GENERAL PRECAUTIONS: 
  Always wash and dry your hands before handling your lenses.  
  DO NOT USE OVER-THE-COUNTER GENERIC HYDROGEN PEROXIDE. 
Generic hydrogen peroxide solutions are not intended for ophthalmic use and may 
contain ingredients not tested for ocular safety or toxicity. Use of generic hydrogen 
peroxide may cause severe burning and stinging if not neutralized before use. In 
addition, generic hydrogen peroxide may contain ingredients that cause 
DISCOLORATION OR DAMAGE TO YOUR CONTACT LENSES. 
  Do not mix or substitute other hydrogen peroxide-based contact lens care products or 
lens cases as inadequate neutralization of hydrogen peroxide may cause severe 
burning and stinging.  
16 
  Contains Nonbinding Recommendations 
 
 
  If lenses are stored for more than [X] hours in [TN] disinfecting solution, disinfect 
your lenses again by replacing the solution in the barrel lens case with fresh [TN] 
disinfection solution and leave to soak for [X] hours to complete the neutralization 
before inserting lenses in the eye. 
  Never reuse the [TN] disinfecting solution. Always discard the remaining solution 
from the lens case. 
  Use before the expiration date marked on the carton and bottle. Always use fresh, 
unexpired lens care solutions. 
  Do not shake/invert the lens case during the disinfection.  
  Discard contents of the bottle [X] months after first opening. 
  Keep the bottle tightly closed when not in use. 
  Store at [X degrees or specify temperature range]. 
  Always keep the lenses completely immersed in the recommended storage solution 
when lenses are not being worn (stored).  Prolonged periods of drying will damage 
lenses/reduce the ability of the lens surface to return to a wettable state.   
  Do not heat the solution and lenses.
 
 
PRECAUTIONS FOR NEUTRALIZING PRODUCTS [WHEN APPLICABLE]: 
  DO NOT use tablets that appear to be broken, chipped, or discolored. 
  DO NOT use tablets from packages which are torn or punctured. 
  DO NOT substitute [TN] Neutralizer components. 
  DO NOT use neutralizing tablets in a heat disinfection unit. 
 
ADVERSE REACTIONS (PROBLEMS AND WHAT TO DO): 
WARNING: 
EYE PROBLEMS, INCLUDING CORNEAL ULCERS, CAN DEVELOP 
RAPIDLY AND LEAD TO LOSS OF VISION; IF YOU EXPERIENCE: 
  Stinging and burning 
  Eye discomfort 
  Excessive tearing 
  Unusual eye secretions 
  Vision changes 
  Loss of vision 
  Eye redness  
  Sensitivity to light (photophobia) 
  Dry eyes 
  Other eye problems 
YOU SHOULD IMMEDIATELY REMOVE THE LENSES, AND PROMPTLY 
CONTACT YOUR EYE CARE PRACTITIONER. 
 
  If you experience stinging and burning, remove your lenses immediately, flush 
(wash) your eyes with a large amount of water or sterile saline for a few minutes. 
If burning and/or irritation persist, seek assistance from an eye care 
professional.  
  If the discomfort or problem stops, remove and inspect the lens.   
17 
  Contains Nonbinding Recommendations 
 
 
  If the lens is in any way damaged, DO NOT put the lens back on the eye. Place the 
lens in the storage case and contact the eye care practitioner.   
  If the lens is not damaged but has dirt, an eyelash, or other foreign body on it, you 
should thoroughly clean, rinse, and disinfect the lenses; then reinsert them.  
  After reinsertion, if the problem continues, IMMEDIATELY remove the lenses and 
consult the eye care practitioner. 
 
If any of the above symptoms occur, a serious condition such as infection, corneal ulcer, 
neovascularization or iritis may be present. Seek immediate professional identification of 
the problem and prompt treatment to avoid serious eye damage. 
 
All adverse reactions observed while using [TN] should be reported to: 
 
[Manufacturer's Name] 
[Manufacturer's Address] 
[Manufacturers Website] 
[U.S.-Based Toll Free Telephone Number] 
 
and can also be reported to FDA MedWatch, 
https://www.accessdata.fda.gov/scripts/medwatch/index.cfm.   
 
GENERAL DIRECTIONS FOR USE: 
  Always wash, rinse and dry your hands before handling your lenses.  This will help to 
prevent eye infections by removing dirt and oils that could get on the lenses. 
 
1)  Place lenses in holder of special [TN] Solution case. Squirt some solution over them. 
2)  Fill the special [TN] Solution case up to the fill line. Put the lens holder in the case. 
Tighten the cap on the [TN] Solution case. 
3)  Soak the lenses in the special [TN] Solution case for a minimum of [X] hours. Your 
lenses are ready to wear after soaking for at least [X] hours. 
DIRECTIONS FOR USE - Soft Lenses: 
Do not put [TN] solution on your lenses and insert directly into the eye or burning 
and stinging will result. 
TO CLEAN, DISINFECT, AND NEUTRALIZE YOUR LENSES: 
  Remove and place each lens into the appropriately marked L/R domed lens 
o
holder. NOTE: To prevent damage to your lens, center the lens on the dome in the 
lens holder. Be sure the lens does not touch the basket rim, then close the basket 
lid. 
  [Specify the total rinse time, in addition to stating the minimum lens rinsing time 
o
for each side of the lens. In addition to your directions that state to rinse the lenses 
for x seconds each, you should also state that the rinse time is for a total of [X] 
seconds.] 
18 
  Contains Nonbinding Recommendations 
 
 
  Fill the lens case to fill line with [TN] solution and place the lens holder in the 
o
case. 
  Tighten the cap and store lenses for at least [insert recommended duration] hours 
o
or overnight. DO NOT SHAKE THE CASE.  
  After soaking for [insert recommended duration] hours, your lenses are ready to 
o
wear. Never rinse your lenses with [TN] solution prior to insertion or burning 
and stinging will result. If desired, lenses can be rinsed with sterile saline before 
inserting.  
 
  Discard the neutralized disinfectant from the cup. Rinse the lens cup with fresh 
o
saline or [TN] solution and allow the case to air dry with the lens holder inverted 
outside the case. Do not place the lens holder on its side. 
 
Your eye care professional may recommend additional products or procedures to care for 
your lenses based on individual tear chemistry and lens wearing schedule. Always follow 
your eye care professionals instructions.  Seek advice from your eye care professional 
before making changes to your care regimen to ensure compatibility with lenses.   
DIRECTIONS FOR USE  RGP Lenses: 
 
Do not put [TN] solution on your lenses and insert directly into the eye or burning 
and stinging will result. 
 
  Remove your lenses one at a time and place them into the appropriately marked 
o
dome basket holder. 
  Place each lens in the palm of your hand, apply 2 to 4 drops of [TN] solution and 
o
rub. While rubbing your lenses with [TN] solution, some users may experience a 
mild, temporary skin discoloration (bleaching) of the fingers or hands. Always 
wash and rinse your hands after rubbing your lenses with the solution. 
  Return the lenses to the appropriate holder and close the baskets. Thoroughly 
o
rinse the lenses for [insert recommended duration] seconds through the basket 
with [TN] solution. 
  Fill the lens case with [TN] solution and place the lens holder in the case. Tighten 
o
the cap and store lenses for at least [insert recommended duration] hours. DO 
NOT SHAKE THE CASE. Do not rinse the lenses. Place the lenses directly on 
the eye from the solution or place a few drops of a contact lens rewetting drop on 
the lens for extra cushioning. 
Your eye care professional may recommend additional products or procedures to care for 
your lenses based on individual tear chemistry and lens wearing schedule. Always follow 
your eye care professionals instructions.  Seek advice from your eye care professional 
before making changes to your care regimen to ensure compatibility with lenses.   
19 
  Contains Nonbinding Recommendations 
 
 
LENS CASE CARE 
  Rinse your lens case with sterile or unexpired contact lens solution (never use tap 
water) and leave the lens case open to dry after each use. Turn the case over and shake 
any excess solution out of the case. Be sure that no residual solution remains in the 
case before you allow it to air dry.  
  Replace your lens case every [insert a recommended time period]. Contact lens cases 
can be a source of bacterial growth.  
 
HOW SUPPLIED: 
[Describe how device is packaged for distribution (e.g., quantity of contents, sterile, 
packaged in bottle, and marked with lot number and expiration date).] 
 
MANUFACTURER OR DISTRIBUTOR NAME AND ADDRESS: 
[Include the information that expresses the following information:  [Distributed 
by/Manufactured by/Manufactured for] Address including zip code, and Manufacturers 
website.] 
 
PRINTED [MONTH AND YEAR]  
   
20 
  Contains Nonbinding Recommendations 
 
 
Appendix B: Carton Labeling Example 
 
This section provides an example of carton labeling for an HPCP containing important product 
information, warnings, and precautions, as described in Section IV.B.2.  
 
 
PRODUCT INFORMATION: 
 
  Principal Display Panel: 
  [Product Trade Name, including emphasis on 3% Hydrogen Peroxide [Solution] 
(e.g., in prominent text) (see Patient Labeling guidance for recommendations on font 
sizes for Headings)] 
  [Actions and Indications (21 CFR 801.61) (e.g., cleans, disinfects)] 
  [Lens Compatibility (i.e., the type of lenses for which the device may be used)] 
  [Net Quantity Contents (21 CFR 801.62)] 
  Sterile 
 
Outer Carton Panels: 
  [Special Storage Conditions (e.g., store at room temperature)] 
  [A statement referring customers to the bottle and package insert for information on 
proper use of the product] 
  [A statement advising users to keep out of reach of children] 
  [Tamper-Resistant Statement (21 CFR 800.12)] 
  [Insert information on whom to contact for concerns, adverse reactions, and 
additional information: [Distributed by/Manufactured by/Manufactured for] Address 
including zip code, website, and phone number.]  
  [Lot Number] 
  [Expiration Date] 
  Product Information: 
  [Description (i.e., Active Ingredients)] 
o
  [Package contents (e.g., a lens case is included)] 
o
  [A statement referring customers to consult the package insert for complete safety 
information] 
  [Website and social media connections (e.g., Quick Response (QR) code, website 
link) to manufacturers and FDA (e.g., Hydrogen Peroxide Solution 
https://www.fda.gov/medical-devices/contact-lenses/hydrogen-peroxide-solution)] 
 
CONTRAINDICATIONS: 
  [Include all known contraindications.  If there are no known contraindications, add 
the statement There are no known contraindications for use of this product.] 
  If you are allergic to any ingredient in this device, DO NOT USE.   
   
21 
  Contains Nonbinding Recommendations 
 
 
WARNINGS: 
   [TN] Solution is neutralized only with the special [TN] Solution case. NEVER use a 
flat lens case. It will cause severe burning and stinging! 
  NEVER soak lenses in [TN] Solution for less than [X] hours. It may cause severe 
burning and stinging! 
  NEVER rinse your lenses with [TN] Solution and put them in your eyes! It will cause 
severe burning and stinging! 
  NEVER squirt [TN] Solution into your eyes or use as an on-eye lens rewetting 
solution! It will cause severe burning and stinging! 
  Contains Hydrogen Peroxide, To avoid injury, follow all directions on the bottle 
and package insert.  
 
Top Left and Right Carton Flaps [in emphasized (e.g., bold, red) text] 
 
Left Flap: [A schematic of a flat lens case, encircled with a line through it, with the 
accompanying verbiage in bold type: DO NOT USE FLAT LENS CASE.] 
 
Right Flap: [A schematic of your lens case, with the accompanying verbiage in bold type: 
USE ONLY THE [TN] LENS CASE PROVIDED.] 
PRECAUTIONS: 
  DO NOT USE OVER-THE-COUNTER GENERIC HYDROGEN PEROXIDE. 
Generic hydrogen peroxide solutions are not intended for ophthalmic use and may 
contain ingredients not tested for ocular safety or toxicity. Use of Generic hydrogen 
peroxide may cause severe burning and stinging if not neutralized before use. 
  Do not mix or substitute other hydrogen peroxide-based lens care products or lens 
cases as inadequate neutralization of peroxide may cause severe burning and stinging.  
   
22 
  Contains Nonbinding Recommendations 
 
 
Appendix C: Bottle Labeling Example 
This section provides an example of bottle labeling for an HPCP solution that contains important 
warnings and directions for use as well as relevant product information, as described in Section 
IV.B.3.  
 
Figure 1: Example of Bottle Labeling 
 
 
 
MANUFACTURER and PRODUCT INFORMATION: 
  [Distributers/Manufacturers name and address including zip code, phone number] 
  [Lot Number]  
  [Expiration Date] 
  [Date Opened ____/or Discard Date_____] 
  [Product Trade Name] 
  [Description (i.e., Active Ingredients), including emphasis on 3% Hydrogen Peroxide 
[Solution] (e.g., in prominent text) located near the Product Trade Name (see Patient 
Labeling guidance for recommendations on font sizes for Headings)] 
  [Actions and Indications (21 CFR 801.61) (e.g., cleans, disinfects, etc.)] 
  [Lens Compatibility (i.e., the type of lenses for which the device may be used)] 
  [Net Quantity Contents (21 CFR 801.62)] 
  Sterile 
  [Special Storage Conditions (e.g., store at room temperature)] 
  [A statement advising users to keep out of reach of children] 
  [A statement referring customers to consult the package insert for complete safety 
information] 
23 
  Contains Nonbinding Recommendations 
 
 
  [Website and social media connections (e.g., Quick Response (QR) code, website link) to 
manufacturers and FDA (e.g., Hydrogen Peroxide Solution 
https://www.fda.gov/medical-devices/contact-lenses/hydrogen-peroxide-solution) ] 
 
DIRECTIONS FOR USE: 
1)  Place lenses in holder of special [TN] Solution case. Squirt some solution over them. 
2)  Fill the special [TN] Solution case up to the fill line. Put the lens holder in the case. 
Tighten the cap on the [TN] Solution case. 
3)  Soak the lenses in the special [TN] Solution case for a minimum of [X] hours. Your 
lenses are ready to wear after soaking for at least [X] hours. 
CONTRAINDICATIONS: 
  [Include all known contraindications.  If there are no known contraindications, add 
the statement There are no known contraindications for use of this product.] 
  If you are allergic to any ingredient in this device, DO NOT USE. 
 
WARNINGS: 
   [TN] Solution is neutralized only with the [TN] Solution case. NEVER use a flat lens 
case. It will cause severe burning and stinging. 
  NEVER soak lenses in [TN] Solution for less than [X] hours. It may cause severe 
burning and stinging. 
  NEVER rinse your lenses with [TN] Solution and put them in your eyes! It will cause 
severe burning and stinging! 
  NEVER squirt [TN] Solution into your eyes! It will cause severe burning and 
stinging! 
 
24