Docosanol

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Docosanol
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

Disclaimer

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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:

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-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.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-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

This image is provided by the National Library of Medicine.

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

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This pill image is provided by the National Library of Medicine's PillBox.

Package and Label Display Panel

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This image of the FDA label is provided by the National Library of Medicine.
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This image of the FDA label is provided by the National Library of Medicine.

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

References

The contents of this FDA label are provided by the National Library of Medicine.


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