Label: COLD SORE FEVER BLISTER TREATMENT- docosanol cream
- NDC Code(s): 79481-0112-1, 79481-0112-7
- Packager: Meijer Distribution Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated January 26, 2024
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
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Directions
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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
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adults and children 12 years or over:
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal Display Panel
COMPARE TO ABREVA®
ACTIVE INGREDIENT**
Docosanol
CREAM, 10%
COLD SORE/FEVER BLISTER TREATMENT
Only FDA-approved medicine to shorten healing time*
Cold sore treatment
NET WT g [oz]
*Docosanol Cream, 10% contains the only OTC medicine approved by the FDA to shorten healing time and duration of symptoms.
**This product is not manufactured or distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC, distributor of Abreva®.
RETAIN THIS INSERT FOR FULL PRODUCT USES, DIRECTIONS AND WARNINGS.
DIST. BY MEIJER DISTRIBUTION, INC.
GRAND RAPIDS, MI 49544
- Package Label
-
INGREDIENTS AND APPEARANCE
COLD SORE FEVER BLISTER TREATMENT
docosanol creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:79481-0112 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:79481-0112-1 2 in 1 PACKAGE 12/31/2023 1 2 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:79481-0112-7 1 in 1 PACKAGE 12/31/2023 2 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 ANDA212385 12/31/2023 Labeler - Meijer Distribution Inc. (006959555)