Label: DOCOSANOL cream
- NDC Code(s): 55301-877-07
- Packager: AAFES/Your Military Exchanges
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated November 25, 2020
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
- Questions or Comments?
Principal display panel
†Compare to active ingredient in Abreva®
Docosanol Cream 10%
Cold Sore/Fever Blister Treatment
- Non-prescription medicine to shorten healing time.*
- Cold sore treatment
- For topical use only
NET WT 2g (0.07 OZ)
*Non-prescription cold sore medicine to shorten healing time and duration of symptoms.
†This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Abreva®.
RETAIN THIS INSERT FOR FULL PRODUCT USES, DIRECTIONS AND WARNINGS.
Manufactured for Your Military Exchanges
200 Hicks Street
Westbury, NY 11590
- Package label
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55301-877 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:55301-877-07 1 in 1 PACKAGE 07/01/2021 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 07/01/2021 Labeler - AAFES/Your Military Exchanges (001695568)