Label: DOCOSANOL cream
- NDC Code(s): 46122-624-07
- Packager: AmerisourceBergen (Good Neighbor Pharmacy) 46122
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated March 29, 2023
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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?
-
Principal Display Panel
†Compare to the 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 2 g (0.07 oz)
†This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Abreva®.
* Non-prescription cold sore medicine to shorten healing time and duration of symptpms.
RETAIN THIS INSERT FOR FULL PRODUCT USES, DIRECTIONS AND WARNINGS
Distributed By AmerisourceBergen
1300 Morris Drive, Chesterbrook, PA 19087
- Package Label
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INGREDIENTS AND APPEARANCE
DOCOSANOL
docosanol creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:46122-624 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:46122-624-07 1 in 1 PACKAGE 08/05/2020 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 10/30/2019 Labeler - AmerisourceBergen (Good Neighbor Pharmacy) 46122 (007914906)