Docosanol
Docosanol is an FDA drug label for the active ingredient DOCOSANOL manufactured by Alembic Pharmaceuticals Inc. administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231222.
Generic: DOCOSANOL
Manufacturer: Alembic Pharmaceuticals Inc.
Product Type: HUMAN OTC DRUG
Route: TOPICAL
Dosage Form:
NDC: 62332-682
Application: ANDA215839
Effective: 20231222
Active Ingredients: Active ingredient Docosanol 10%
Indications & Usage
Uses treats cold sores/fever blisters on the face or lips shortens healing time and duration of symptoms: • tingling, pain, burning, and/or itching
Dosage & Administration
Directions 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
Contraindications
Not available.
Warnings
Warnings Allergy Alert This product may cause a severe allergic reaction. Symptoms may include: hives facial swelling wheezing/difficulty breathing shock rash If an allergic reaction occurs, stop use and seek medical help right away. For external use only Do not use if you are allergic to any ingredient in this product When using this product apply only to the 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 the infection. Stop use and ask a doctor if your cold sore gets worse or the cold sore is not healed within 10 days
Adverse Reactions
Not available.
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