Label: COLD SORE FEVER BLISTER TREATMENT- docosanol cream
- NDC Code(s): 11822-6500-7
- Packager: Rite Aid Corporation
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated July 19, 2023
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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?
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Principal Display Panel
Compare to the active ingredient in Abreva®†
COLD SORE / FEVER BLISTER TREATMENT
DOCOSANOL CREAM 10%
Only FDA-approved medicine to shorten healing time*
Cold sore treatment
For topical use only
Portable convenient pump
NET WT 2 g (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 GSK Consumer Healthcare, distributor of Abreva®.
RETAIN THIS INSERT FOR FULL PRODUCT USES, DIRECTIONS AND WARNINGS
DISTRIBUTED BY: RITE AID,
200 NEWBERRY COMMONS
ETTERS, PA 17319
www.riteaid.com
- Package Label
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INGREDIENTS AND APPEARANCE
COLD SORE FEVER BLISTER TREATMENT
docosanol creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11822-6500 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:11822-6500-7 2 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 07/07/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA212385 07/07/2023 Labeler - Rite Aid Corporation (014578892)