This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
ALTRENO safely and effectively. See full prescribing information for
ALTRENO.

----------------------- WARNINGS AND PRECAUTIONS ----------------------­• Skin Irritation: Dryness, pain, erythema, irritation and exfoliation may
occur with use of ALTRENO. (5.1)•

Ultraviolet Light and Environmental Exposure: Minimize exposure to
sunlight and sunlamps. Use sunscreen and protective clothing when sun
exposure cannot be avoided. (5.2)•

Fish Allergies: Use ALTRENO with caution if allergic to fish due topotential for allergenicity to fish protein. Advise patients to contact theirhealthcare provider if they develop pruritus or urticaria. (5.3)™

ALTRENO (tretinoin) lotion, for topical use
Initial U.S. Approval: 1973--------------------------- INDICATIONS AND USAGE---------------------------­
ALTRENO is a retinoid indicated for
The the topical treatment of acne vulgaris in patients 9 years of age and older.
(1)-----------------------DOSAGE AND ADMINISTRATION ----------------------­• Apply a thin layer of ALTRENO to affected areas once daily. Avoid eyes,mouth, paranasal creases, and mucous membranes. (2)• Not for ophthalmic, oral, or intravaginal use. (2)--------------------- DOSAGE FORMS AND STRENGTHS---------------------­
Lotion, 0.05% (3)Each gram of ALTRENO contains 0.5 mg (0.05%) tretinoin. (3)------------------------------ CONTRAINDICATIONS -----------------------------­
None. (4)------------------------------ ADVERSE REACTIONS -----------------------------­• The most common adverse reactions occurring in ≥1% of subjects andgreater than vehicle were dryness, pain, erythema, irritation andexfoliation (all at the application site). (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Valeant
Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800­
FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION and FDAapproved patient labeling.
Revised: 08/2018

FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Skin Irritation
5.2 Ultraviolet Light and Environmental Exposure
5.3 Fish Allergies
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
8. USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation

Reference ID: 4311140

8.4 Pediatric Use
8.5 Geriatric Use
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION*Sections or subsections omitted from the full prescribing information are notlisted.

This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda

FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE
ALTRENO™ (tretinoin) lotion, 0.05% is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.

2 DOSAGE AND ADMINISTRATION
Apply a thin layer of ALTRENO to the affected areas once daily. Avoid the eyes, mouth, paranasal creases, and mucous membranes.
ALTRENO is for topical use only. Not for ophthalmic, oral, or intravaginal use.

3 DOSAGE FORMS AND STRENGTHS
Lotion, 0.05%
Each gram of ALTRENO contains 0.5 mg (0.05%) tretinoin in an opaque, pale yellow topical lotion.

4 CONTRAINDICATIONS
None.

5 WARNINGS AND PRECAUTIONS
5.1 Skin Irritation
Patients using ALTRENO may experience application site dryness, pain, erythema, irritation, and exfoliation. Depending upon theseverity of these adverse reactions, instruct patients to use a moisturizer, reduce the frequency of the application of ALTRENO, or
discontinue use. Avoid application of ALTRENO to eczematous or sunburned skin.

5.2 Ultraviolet Light and Environmental Exposure
Minimize unprotected exposure to ultraviolet light including sunlight and sunlamps during the use of ALTRENO. Warn patients who
normally experience high levels of sun exposure and those with inherent sensitivity to sun to exercise caution. Use sunscreen products
and protective clothing over treated areas when sun exposure cannot be avoided.

5.3 Fish Allergies
ALTRENO contains soluble fish proteins. Use with caution in patients with known sensitivity or allergy to fish. Advise patients tocontact their healthcare provider if they develop pruritus or urticaria.

6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug
cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
In 2 randomized, double- blind, vehicle-controlled trials, subjects age 9 years and older applied ALTRENO or vehicle once daily for
12 weeks. The majority of subjects were White (74%) and female (55%). Approximately 47% were Hispanic/Latino and 45% wereyounger than 18 years of age. Adverse reactions reported by ≥1% of subjects treated with ALTRENO and more frequently thanvehicle are summarized in Table 1.

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This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
Table 1: Adverse Reactions Reported by ≥1% of Subjects Treated with ALTRENO and More Frequently than Vehicle
Adverse Reactionsn (%)
ALTRENO
N=767

VehicleN=783

29 (4)

1 (<1)

Application site pain

25 (3)

3 (<1)

Application site erythema

12 (2)

1 (<1)

Application site irritation

7 (1)

1 (<1)

Application site exfoliation

6 (1)

3 (<1)

Application site dryness
1

1

Application site pain defined as application site stinging, burning or pain.

Skin irritation was evaluated by active assessment of erythema, scaling, hypopigmentation, hyperpigmentation, itching, burning andstinging. The percentage of subjects who were assessed to have these signs and symptoms at any post baseline visit are summarized inTable 2.
Table 2: Application Site Tolerability Reactions at Any Post Baseline Visit

Erythema
Scaling
Hypopigmentation
Hyperpigmentation
Itching
Burning
Stinging

ALTRENO
N=760
Mild/Mod/Severe

VehicleN=782
Mild/Mod/Severe

51%
49%
12%
35%
35%
30%
21%

44%
30%
10%
35%
28%
14%
8%

8. USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Available data from published observational studies of topical tretinoin in pregnant women have not established a drug-associated riskof major birth defects, miscarriage, or adverse maternal or fetal outcomes. There are no data on ALTRENO use in pregnant women.
The systemic levels following topical administration are lower than with administration of oral tretinoin; however, absorption of thisproduct may result in fetal exposure. There are reports of major birth defects similar to those seen in infants exposed to oral retinoids,
but these case reports do not establish a pattern or association with tretinoin-related embryopathy (see Data).
Animal reproduction studies have not been conducted with ALTRENO. Topical administration of tretinoin in a different formulation
to pregnant rats during organogenesis was associated with malformations (craniofacial abnormalities [hydrocephaly], asymmetricalthyroids, variations in ossification, and increased supernumerary ribs) at doses up to 0.5 mg tretinoin/kg/day, approximately 2 times
the maximum recommended human dose (MRHD) based on body surface area (BSA) comparison and assuming 100% absorption.
Oral administration of tretinoin to pregnant cynomolgus monkeys during organogenesis was associated with malformations at
10 mg/kg/day (approximately 100 times the MRHD based on BSA comparison and assuming 100% absorption) (see Data).
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have abackground risk of major birth defects, loss, and other adverse outcomes. The background risk in the U.S. general population of majorbirth defects is 2 to 4% and of miscarriage is 15 to 20% of clinically recognized pregnancies.

Reference ID: 4311140

This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
Data
Human Data
While available studies cannot definitively establish the absence of risk, published data from multiple prospective controlled
observational studies on the use of topical tretinoin products during pregnancy have not identified an association with topical tretinoin
and major birth defects or miscarriage. The available studies have methodologic limitations, including small sample size and in somecases, lack of physical exam by an expert in birth defects. There are published case reports of infants exposed to topical tretinoin
during the first trimester that describe major birth defects similar to those seen in infants exposed to oral retinoids; however, no patternof malformations has been identified and no causal association has been established in these cases. The significance of these
spontaneous reports in terms of risk to the fetus is not known.
Animal Data
Tretinoin in a 0.05% gel formulation was topically administered to pregnant rats during organogenesis at doses of 0.1, 0.3 and1 g/kg/day (0.05, 0.15, 0.5 mg tretinoin/kg/day). Possible tretinoin malformations (craniofacial abnormalities [hydrocephaly],
asymmetrical thyroids, variations in ossification, and increased supernumerary ribs) were observed at maternal doses of 0.5 mg
tretinoin/kg/day (approximately 2 times the MRHD based on BSA comparison and assuming 100% absorption). These findings were
not observed in control animals. Other maternal and reproductive parameters in tretinoin-treated animals were not different fromcontrol. For purposes of comparison of the animal exposure to human exposure, the MRHD is defined as 4 g of ALTRENO applied
daily to a 60-kg person.
Other topical tretinoin embryofetal development studies have generated equivocal results. There is evidence for malformations(shortened or kinked tail) after topical administration of tretinoin to pregnant Wistar rats during organogenesis at doses greater than
1 mg/kg/day (approximately 5 times the MRHD based on BSA comparison and assuming 100% absorption). Anomalies (humerus:
short 13%, bent 6%, os parietal incompletely ossified 14%) have also been reported when 10 mg/kg/day (approximately 50 times the
MRHD based on BSA comparison and assuming 100% absorption) was topically applied to pregnant rats during organogenesis.
Supernumerary ribs have been a consistent finding in rat fetuses when pregnant rats were treated topically or orally with retinoids.
Oral administration of tretinoin during organogenesis has been shown to induce malformations in rats, mice, rabbits, hamsters, andnonhuman primates. Fetal malformations were observed when tretinoin was orally administered to pregnant Wistar rats duringorganogenesis at doses greater than 1 mg/kg/day (approximately 5 times the MRHD based on BSA comparison). In the cynomolgus
monkey, fetal malformations were reported when an oral dose of 10 mg/kg/day was administered to pregnant monkeys duringorganogenesis (approximately 100 times the MRHD based on BSA comparison). No fetal malformations were observed at an oral
dose of 5 mg/kg/day (approximately 50 times the MRHD based on BSA comparison). Increased skeletal variations were observed at
all doses in this study and dose-related increases in embryo lethality and abortion were reported in this study. Similar results have also
been reported in pigtail macaques.
Oral tretinoin has been shown to be fetotoxic in rats when administered at doses 10 times the MRHD based on BSA comparison.
Topical tretinoin has been shown to be fetotoxic in rabbits when administered at doses 4 times the MRHD based on BSA comparison.

8.2 Lactation
Risk Summary
There are no data on the presence of tretinoin or its metabolites in human milk, the effects on the breastfed infant, or the effects on
milk production. It is not known whether topical administration of tretinoin could result in sufficient systemic absorption to produce
detectable concentrations in human milk. The developmental and health benefits of breastfeeding should be considered along with themother’s clinical need for ALTRENO and any potential adverse effects on the breastfed child from ALTRENO.

8.4 Pediatric Use
Safety and effectiveness of ALTRENO for the topical treatment of acne vulgaris have been established in pediatric patients age 9
years to less than 17 years based on evidence from two multicenter, randomized, double-blind, parallel-group, vehicle-controlled, 12­
week trials and an open-label pharmacokinetic study. A total of 318 pediatric subjects aged 9 to less than 17 years received
ALTRENO in the clinical studies [see Clinical Pharmacology (12.3) and Clinical Studies (14) ].

Reference ID: 4311140

This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
The safety and effectiveness of ALTRENO in pediatric patients below the age of 9 years have not been established.

8.5 Geriatric Use
Clinical trials of ALTRENO did not include any subjects age 65 years and older to determine whether they respond differently fromyounger subjects.

11 DESCRIPTIONALTRENO (tretinoin) lotion is an opaque, pale yellow lotion containing 0.05% tretinoin by weight for topical administration.
Chemically, tretinoin is all-trans-retinoic acid, also known as (all-E)-3,7-dimethyl-9-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4,6,8­
nonatetraenoic acid. It is a member of the retinoid class of compounds and a metabolite of vitamin A. Tretinoin has the following
chemical structure:

Molecular Formula: C20H28O2

Molecular Weight: 300.44

Each gram of ALTRENO contains 0.5 mg (0.05%) of tretinoin in an opaque, pale yellow lotion base consisting of benzyl alcohol,
butylated hydroxytoluene, carbomer copolymer type B (Pemulen TR-1), carbomer homopolymer type A (Carbopol 981), glycerin,
methylparaben, mineral oil, octoxynol-9, purified water, sodium hyaluronate, soluble collagen and trolamine.

12 CLINICAL PHARMACOLOGY
12.1 MECHANISM OF ACTION
Tretinoin is a metabolite of vitamin A that binds with high affinity to specific retinoic acid receptors located in both the cytosol andnucleus.
Tretinoin activates three members of the retinoic acid (RAR) nuclear receptors (RARα, RARβ, and RARγ) which act to modify gene
expression, subsequent protein synthesis, and epithelial cell growth and differentiation. It has not been established whether the clinicaleffects of tretinoin are mediated through activation of retinoic acid receptors, other mechanisms, or both.
Although the exact mode of action of tretinoin in acne treatment is unknown, current evidence suggests that topical tretinoin decreases
cohesiveness of follicular epithelial cells with decreased microcomedo formation. Additionally, tretinoin stimulates mitotic activity
and increased turnover of follicular epithelial cells causing extrusion of the comedones.

12.2 Pharmacodynamics
The pharmacodynamics of ALTRENO in the treatment of acne vulgaris are unknown.

12.3 Pharmacokinetics
Plasma concentrations of tretinoin and its major metabolites (isotretinoin and 4-oxo-isotretinoin) were evaluated in 20 subjects in an
open-label, randomized, pharmacokinetic study. Subjects aged 10 years to less than 17 years old with acne vulgaris applied
approximately 3.5 g of ALTRENO to the skin of the entire face (excluding eyes and lips), neck, upper chest, upper back andshoulders once daily for 14 days. Single-dose pharmacokinetic (PK) characteristics were determined from samples drawn on Days 1
and 2 of dosing and steady-state PK characteristics were determined from samples drawn on Days 14 and 15 under maximal use
conditions. The mean baseline corrected Cmax and AUC0-t of tretinoin and its metabolites after once daily application of ALTRENO for
14 days are shown below:
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This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
CompoundTretinoin

Mean (±SD) Cmax
(ng/mL)
0.33 (0.33)

Mean (±SD) AUC0-t(ng*h/mL)
6.46 (5.15)

0.49 (0.66)
0.57 (0.82)

9.30 (9.95)
14.51 (18.28)

Isotretinoin
4-oxo-isotreinoin

The mean concentrations of tretinoin and its metabolites (isotretinoin and 4-oxo-isotretinoin) remain relatively stable and unchanged
over the 24-hour period after both the Day 1 dose and the Day 14 dose. Systemic concentrations of tretinoin appear to be at or nearsteady state by Day 14. Mean accumulation ratios of the baseline corrected AUC between Day 14 and Day 1 were 1.5, 4.5 and 7.3 fortretinoin, isotretinoin, and 4-oxo-isotretinoin, respectively.

13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
A 2-year dermal mouse carcinogenicity study was conducted with topical administration of 0.005%, 0.025% and 0.05% of a tretinoin
gel formulation. Although no drug-related tumors were observed in surviving animals, the irritating nature of the drug productprecluded daily dosing, confounding data interpretation and reducing the biological significance of these results.
Studies in hairless albino mice with a different formulation suggest that concurrent exposure to tretinoin may enhance the tumorigenic
potential of carcinogenic doses of UVB and UVA light from a solar simulator. This effect was confirmed in a later study in pigmented
mice, and dark pigmentation did not overcome the enhancement of photocarcinogenesis by 0.05% tretinoin. Although the significanceof these studies to humans is not clear, patients should minimize exposure to sunlight or artificial ultraviolet irradiation sources.
The genotoxic potential of tretinoin was evaluated in an in vitro bacterial reversion test, an in vitro chromosomal aberration assay inhuman lymphocytes and an in vivo rat micronucleus assay. All tests were negative.
In dermal fertility studies of another tretinoin formulation in rats, slight (not statistically significant) decreases in sperm count andmotility were seen at 0.5 mg/kg/day (approximately 2 times the MRHD based on BSA comparison and assuming 100% absorption),and slight (not statistically significant) increases in the number and percent of nonviable embryos in females treated with
0.25 mg/kg/day and above (approximately the MRHD based on BSA comparison and assuming 100% absorption) were observed.

14 CLINICAL STUDIESThe safety and efficacy of once daily use of ALTRENO for the treatment of acne vulgaris were assessed in two multicenter,randomized, double-blind clinical trials enrolling 1640 subjects age 9 years and older with acne vulgaris. Enrolled subjects had a scoreof moderate (3) or severe (4) on the Evaluator’s Global Severity Score (EGSS), 20 to 40 inflammatory lesions (papules, pustules, andnodules), 20 to 100 non-inflammatory lesions (open and closed comedones) and two or fewer facial nodules. The coprimary efficacy
endpoints of success on the EGSS, absolute change in noninflammatory lesion count, and absolute change in inflammatory lesion
count were assessed at Week 12. Success on the EGSS was defined as at least a 2-grade improvement from Baseline and an EGSS
score of clear (0) or almost clear (1). Table 3 lists the efficacy results for trials 1 (NCT02491060) and 2 (NCT02535871).
Table 3: Efficacy Results at Week 12
Trial 1
EGSS
Clear or Almost Clear and2-Grade Reduction from Baseline
Non-Inflammatory Facial Lesions
Mean Absolute Reduction
Mean Percent Reduction
Inflammatory Facial Lesions
Mean Absolute Reduction
Mean Percent Reduction
Trial 2

Reference ID: 4311140

ALTRENO
N=406

Vehicle
N=414

16.5%

6.9%

17.8
47.5%

10.6
27.3%

13.1
50.9%
ALTRENO
N=413

10.2
40.4%
VehicleN=407

This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
EGSS
Clear or Almost Clear and2-Grade Reduction from Baseline
Non-Inflammatory Facial Lesions
Mean Absolute Reduction
Mean Percent Reduction
Inflammatory Facial Lesions
Mean Absolute Reduction
Mean Percent Reduction

19.8%

12.5%

21.9
45.6%

13.9
31.9%

13.9
53.4%

10.7
41.5%

16 HOW SUPPLIED/STORAGE AND HANDLINGALTRENO (tretinoin) lotion, 0.05% is an opaque, pale yellow topical lotion and available as:•

45 g tube (NDC 0187-0005-45)

Storage and Handling Conditions
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
Protect from freezing.

17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
•

Warn patients of the potential for skin irritation during treatment.

•

Advise patients to minimize exposure to sunlight and sunlamps; recommend the use of sunscreen products and protective
apparel (e.g., hat) when sun exposure cannot be avoided.

Manufactured for:Dow Pharmaceutical Sciences, a division of Valeant Pharmaceuticals North America LLC
Bridgewater, NJ 08807 USA
By:
Valeant Pharmaceuticals International, Inc.
Laval, Quebec H7L 4A8, Canada
U.S. Patent Number: 6,517,847
Altreno is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates.
© Valeant Pharmaceuticals North America LLC

Reference ID: 4311140

08/2018

This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
PATIENT INFORMATIONALTRENO™ (al-TREN-oh)(tretinoin) lotion, 0.05%
for topical use
Important information: ALTRENO is for use on skin only. Do not use ALTRENO in your eyes, mouth, the corners of yournose, or vagina.
What is ALTRENO?
ALTRENO is a prescription medicine used on the skin (topical) to treat people with acne. Acne is a condition in which theskin has blackheads, whiteheads, and other pimples.
It is not known if ALTRENO is safe and effective in children under 9 years of age.
Before using ALTRENO, tell your healthcare provider about all your medical conditions, including if you:•are allergic to fish. ALTRENO contains fish proteins. Tell your healthcare provider if you get hives or itching while usingwith ALTRENO.

•
•
•
•

have eczema or any other skin problems.
have a sunburn.
are pregnant or plan to become pregnant. It is not known if ALTRENO will harm your unborn baby.

are breastfeeding or plan to breastfeed. It is not known if ALTRENO passes into your breast milk.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines,
vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your healthcare provider andpharmacist when you get a new medicine.
How should I use ALTRENO?
• Use ALTRENO exactly as your healthcare provider tells you to use it.
• Apply a thin layer of ALTRENO to cover the affected areas 1 time each day.
What should I avoid while using ALTRENO?
• You should avoid sunlamps, tanning beds, and ultraviolet light during treatment with ALTRENO.
• Minimize exposure to sunlight.
• If you have to be in the sunlight or are sensitive to sunlight, use a sunscreen with a SPF (sun protection factor) of 15 ormore and wear protective clothing and a wide-brimmed hat to cover the treated areas.
What are the possible side effects of ALTRENO?
ALTRENO may cause serious side effects, including:
Skin irritation. ALTRENO may cause irritation including skin dryness, pain, redness, excessive flaking or peeling. If you
develop these symptoms, your healthcare provider may tell you to use a moisturizer, decrease the number of times you
apply ALTRENO, or completely stop treatment with ALTRENO. Avoid applying ALTRENO to skin that is affected byeczema or sunburned skin.
These are not all the possible side effects of ALTRENO.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store ALTRENO?
• Store ALTRENO at room temperature between 68 to 77°F (20 to 25°C).
• Do not freeze.
Keep ALTRENO and all medicines out of the reach of children.
General information about the safe and effective use of ALTRENO
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use
ALTRENO for a condition for which it was not prescribed. Do not give ALTRENO to other people, even if they have thesame symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information
about ALTRENO that is written for health professionals.
What are the ingredients in ALTRENO?
Active ingredient: tretinoin

1

Reference ID: 4311140

This label may not be the latest approved by FDA.
For current labeling information, please visit https://www.fda.gov/drugsatfda
Inactive ingredients: benzyl alcohol, butylated hydroxytoluene, carbomer copolymer type B (Pemulen TR-1), carbomer
homopolymer type A (Carbopol 981), glycerin, methylparaben, mineral oil, octoxynol-9, purified water, sodium hyaluronate,soluble collagen and trolamine.
Manufactured for: Dow Pharmaceutical Sciences, a division of Valeant Pharmaceuticals North America LLC, Bridgewater,
NJ 08807 USA
By: Valeant Pharmaceuticals International, Inc., Laval, Quebec H7L 4A8, Canada.
For more information, call 1-800-321-4576.
U.S. Patent Number: 6,517,847
Altreno is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates.
© Valeant Pharmaceuticals North America LLC
This Patient Information has been approved by the U.S. Food and Drug Administration.

2

Reference ID: 4311140

Issued: 08/2018