Label: DOCOSANOL cream
- NDC Code(s): 83455-112-07
- Packager: United Natural Foods, Inc. dba UNFI
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 18, 2024
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- Download DRUG LABEL INFO: PDF XML
- 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?
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Principal display panel
Compare to active ingredient in Abreva®†
Docosanol Cream 10%
Cold sore/fever blister treatment
- Only FDA approved medicine to shorten healing time*
- Cold sore treatment
For topical use only
NET WT 2g (0.07 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, DIRECTION AND WARNINGS.
DISTRIBUTED BY: UNFI
PROVIDENCE, RI 02908
- Package label
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INGREDIENTS AND APPEARANCE
DOCOSANOL
docosanol creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83455-112 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 (HLB 5) (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:83455-112-07 1 in 1 PACKAGE 12/31/2023 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 ANDA212385 12/31/2023 Labeler - United Natural Foods, Inc. dba UNFI (943556183)