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Docosanol drug information

DOCOSANOL
KLM Laboratories Private Limited · TOPICAL

Product NDC: 84725-001

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Source label information, not individualized medical advice. This record applies to the product and labeler shown below. Compare the exact formulation, strength and country with your package and the current source label.
Generic nameDOCOSANOL
Labeler / manufacturerKLM Laboratories Private Limited
RouteTOPICAL
Drug classDrug class not supplied in source label
Product NDC84725-001
Label effective date2026-09-08

Official product label reference

Docosanol — KLM Laboratories Private Limited

This page contains 12 source sections for DOCOSANOL, topical route. Label set 5783edbf-2ce6-4b7e-8df3-2e421c63d0e8, version 10.

Retrieved 2026-10-02 · openFDA dataset updated 2026-10-02 · Check the current DailyMed label

Label records can cover multiple strengths or package sizes. A label listing does not by itself establish FDA approval or current market availability. Check the source and application history for this specific product.

Uses described in the label

Uses treats cold sores/fever blisters on the face or lips shortens healing time and duration of symptoms: tingling, pain, burning, and/or itching

Purpose

Purpose Cold sore/fever blister treatment
Dosage and administration — label text
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
Warnings
Warnings Allergy alert: This product may cause a severe allergic reaction. Syptoms 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
Unclassified section
Drug Facts Questions or comments? call toll-free 1-833-663-2933 from Monday to Friday between 9:00 am to 5.00 pm Distributed by: One2Zee LLC, 61 Bay Hill Blvd, Monroe Township, NJ 08831 Active ingredient made in India Additional information Docosanol Cream, 10% contains the only OTC medicine approved by the FDA to shorten healing time and duration of symptoms. Retain this carton for full product uses, directions and warnings. If you are not completely satisfied, save receipt and remaining product, and call us at 1-833-663-2933 Thank you for purchasing Docosanol Cream, 10%. We hope that since Docosanol Cream shortens the healing time of cold sores, it helps you look and feel better faster. Please follow insert directions for proper use and refer to the information below. You are not alone An estimated one-in-five Americans is affected by cold sores each year. Most people who experience them get two to three cold sore outbreaks each year. Just before and during an outbreak, the cold sore infection can be easily passed on to others. It is especially important to be aware of early warning signs that a cold sore is coming, and to be sure to avoid close physical contact when you have one. Getting to the Root of the Problem A blister, or cluster of blisters around your mouth, is caused by the cold sore virus. After the cold sore has healed, the virus stays dormant in your body but can be reactivated by everyday triggers like stress, sunlight, extreme hot or cold weather, colds and flu, lack of sleep, or menstruation. The Sooner, the Better A typical cold sore outbreak can last as long as seven to ten days. The sooner you begin using Docosanol Cream, 10%, the more effective the medicine will be. So for best results, use Docosanol Cream, 10% at the very start of the cold sore - when you feel the first sign of the tingle, redness, bump or itch. Docosanol Cream, 10% is different from other over-the-counter cold sore products. Only Docosanol Cream, 10% contains 10% docosanol, which helps to shorten the healing time of cold sores and the duration of symptoms including tingling, pain, itching and burning. Frequently Asked Questions: For Pump Bottle How to use your Docosanol Cream, 10% Pump - For Adults and children 12 years and over can use Docosanol Cream, 10%. - Docosanol Cream, 10% 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. - If you wish, you can apply cosmetics such as lipstick over Docosanol Cream, 10%. 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 Docosanol Cream, 10%. Press Pump completely about 6-8 times to get first dose. STEP 1 – Wash your hands before and after treating the cold sore. STEP 2 – Remove cap and press pump firmly. When first used, expect to press pump completely about 6-8 times before obtaining first dose. STEP 3 – Rub in gently but completely 5 times a day until healed for maximum of 10 days. STEP 4 – Place cap back on pump after each use. For Tube Who can use Docosanol Cream, 10%? Adults and children 12 years and over can use Docosanol Cream, 10%. How often can I apply Docosanol Cream, 10%? Docosanol Cream, 10% 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 Docosanol Cream, 10%? Yes, cosmetics such as lipstick may be applied over Docosanol Cream, 10%. 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 Docosanol Cream, 10%. pump-steps
Active ingredient
Active Ingredient Docosanol 10%
Do not use
Do not use if you are allergic to any ingredient in this product
While using this medicine
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.
When to stop use and seek help
Stop use and ask doctor if your cold sore gets worse or the cold sore is not healed within 10 days
Child safety
Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.
Storage and handling
Other Information store at 20°-25°C (68°-77°F). do not freeze.
Inactive ingredient
Inactive ingredients benzyl alcohol, light mineral oil, propylene glycol, purified water, sucrose distearate, sucrose stearate

Official sources and product identifiers

Substances listed: DOCOSANOL

RxNorm identifiers: 797534

Package NDC codes

84725-001-01, 84725-001-02

Further research and background

These are external searches for related information. Research, encyclopedia and news articles have not been imported into this product record.

Coverage and corrections

The text is extracted from a US structured product label. Tables are represented as text where supplied; formatting and illustrations may be lost. A missing section does not mean a risk is absent. This reference has not been independently reviewed by a clinician and is not a live safety-alert service.

Source retrieved 2026-10-02. Read the source policy.