Label: DOCOSANOL cream
- NDC Code(s): 0591-2981-35
- Packager: Actavis Pharma, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated April 9, 2019
If you are a consumer or patient please visit this version.
- Active ingredient
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
adults and children 12 years or over:
- wash hands before and after applying cream
- apply to affected area on the 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
- adults and children 12 years or over:
- Other information
- Inactive ingredients
1-888-838-2872 between 9 am and 5 pm ET, Monday–Friday.
Docosanol Cream, 10%
Thank you for purchasing Docosanol Cream. 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, the more effective the medicine will be. So for best results, use Docosanol Cream at the very start of the cold sore - when you feel the first sign of the tingle, redness, bump or itch.
Docosanol Cream is different from other over-the-counter cold sore products. Only Docosanol Cream 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:
How is Docosanol Cream different from the over-the-counter cold sore remedies I have already been using?
Docosanol Cream is a non-prescription cold sore medicine that can actually shorten healing time and the duration of symptoms. The sooner you start using Docosanol Cream, the sooner you can begin healing your cold sore.
Who can use Docosanol Cream?
Adults and children 12 years and over can use Docosanol Cream.
How often can I apply Docosanol Cream?
Docosanol Cream 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?
Yes, cosmetics such as lipstick may be applied over Docosanol Cream. 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.
Made in the USA
Distributed by: Actavis Pharma, Inc.
Parsippany, NJ 07054 USA
Revised – March 2016
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0591-2981 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DOCOSANOL (UNII: 9G1OE216XY) (DOCOSANOL - UNII:9G1OE216XY) DOCOSANOL 100 mg in 1 g Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL (UNII: LKG8494WBH) LIGHT MINERAL OIL (UNII: N6K5787QVP) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SUCROSE DISTEARATE (UNII: 33X4X4B90S) SUCROSE STEARATE (UNII: 274KW0O50M) Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0591-2981-35 1 in 1 PACKAGE 04/05/2019 1 2 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA208754 04/05/2019 Labeler - Actavis Pharma, Inc. (119723554) Establishment Name Address ID/FEI Business Operations Actavis Laboratories UT, Inc. 079589880 LABEL(0591-2981) , MANUFACTURE(0591-2981) , PACK(0591-2981)