Docosanol

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NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

# Overview
Docosanol is an antiviral cream that is FDA approved for the treatment of cold sores, fever, blisters on the face or lips.   Common adverse reactions include application site reaction.

# Adult Indications and Dosage

## FDA-Labeled Indications and Dosage (Adult)

# Indications
- Treats cold sores/fever, blisters on the face or lips
- Shortens healing time and duration of symptoms:
- Tingling, pain, burning, and/or itching

## Off-Label Use and Dosage (Adult)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Docosanol in adult patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Docosanol in adult patients.

# Pediatric Indications and Dosage

## FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-Labeled Use of Docosanol in pediatric patients.

## Off-Label Use and Dosage (Pediatric)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Docosanol in pediatric patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Docosanol in pediatric patients.

# Contraindications
There is limited information regarding Docosanol Contraindications in the drug label.

# Warnings
For external use only
Do not use
- If you are allergic to any ingredient in this product
When using this product
Apply only to affected areas
- Do not use in or near the eyes
- Avoid applying directly inside your mouth
- Do not share this product with anyone. This may spread infection.
Stop use and ask a doctor if
- Your cold sore gets worse or the cold sore is not healed within 10 days
- Keep out of reach of children.
- If swallowed, get medical help or contact a poison control center right away.

# Adverse Reactions

## Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Docosanol in the drug label.

## Postmarketing Experience
There is limited information regarding Postmarketing Experience of Docosanol in the drug label.

# Drug Interactions
There is limited information regarding Docosanol Drug Interactions in the drug label.

# Use in Specific Populations

### Pregnancy
Pregnancy Category (FDA):
- Pregnancy Category
Pregnancy Category (AUS):
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Docosanol in women who are pregnant.

### Labor and Delivery
There is no FDA guidance on use of Docosanol during labor and delivery.

### Nursing Mothers
There is no FDA guidance on the use of Docosanol with respect to nursing mothers.

### Pediatric Use
There is no FDA guidance on the use of Docosanol with respect to pediatric patients.

### Geriatic Use
There is no FDA guidance on the use of Docosanol with respect to geriatric patients.

### Gender
There is no FDA guidance on the use of Docosanol with respect to specific gender populations.

### Race
There is no FDA guidance on the use of Docosanol with respect to specific racial populations.

### Renal Impairment
There is no FDA guidance on the use of Docosanol in patients with renal impairment.

### Hepatic Impairment
There is no FDA guidance on the use of Docosanol in patients with hepatic impairment.

### Females of Reproductive Potential and Males
There is no FDA guidance on the use of Docosanol in women of reproductive potentials and males.

### Immunocompromised Patients
There is no FDA guidance one the use of Docosanol in patients who are immunocompromised.

# Administration and Monitoring

### Administration
- Topical

### Monitoring
There is limited information regarding Monitoring of Docosanol in the drug label.

# IV Compatibility
There is limited information regarding IV Compatibility of Docosanol in the drug label.

# Overdosage
There is limited information regarding Chronic Overdose of Docosanol in the drug label.

# Pharmacology

## Mechanism of Action
There is limited information regarding Docosanol Mechanism of Action in the drug label.

## Structure
There is limited information regarding Docosanol Structure in the drug label.

## Pharmacodynamics
There is limited information regarding Pharmacodynamics of Docosanol in the drug label.

## Pharmacokinetics
There is limited information regarding Pharmacokinetics of Docosanol in the drug label.

## Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Docosanol in the drug label.

# Clinical Studies
There is limited information regarding Clinical Studies of Docosanol in the drug label.

# How Supplied
There is limited information regarding Docosanol How Supplied in the drug label.

## Storage
- Store at 20 o-25 oC (68 o-77 oF)
- Do not freeze

# Images

## Drug Images

## Package and Label Display Panel

# Patient Counseling Information
Adults and children 12 years or over:
- Wash hands before and after applying cream
- Apply to affected area on face or lips at the first sign of cold sore/fever blister (tingle).
- Early treatment ensures the best results
- Rub in gently but completely
- Use 5 times a day until healed
Children under 12 years: ask a doctor
FREQUENTLY ASKED QUESTIONS:
How is ABREVA different from the over-the-counter cold sore remedies I have already been using?
- Abreva is the only FDA approved non-prescription cold sore medicine that can actually shorten healing time and the duration of symptoms. The sooner you start using ABREVA, the sooner you can begin healing your cold sore.
Who can use ABREVA?
- Adults and children 12 years and over can use ABREVA.
How often can I apply ABREVA?
- ABREVA should be used five times a day until the cold sore is healed. Apply it directly to the cold sore at the first sign of a tingle, redness, bump or itch for best results.
Can I apply cosmetics on top of ABREVA?
- Yes, cosmetics such as lipstick may be applied over ABREVA. However, use a separate applicator, like a cotton swab, to apply cosmetics over an unhealed cold sore to avoid spreading the infection. For best results, remove any cosmetics prior to applying ABREVA.

# Precautions with Alcohol
- Alcohol-Docosanol interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

# Brand Names
ABREVA

# Look-Alike Drug Names
There is limited information regarding Docosanol Look-Alike Drug Names in the drug label.

# Drug Shortage Status

# Price