Label: DOCOSANOL cream
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Contains inactivated NDC Code(s)
NDC Code(s): 71589-019-01, 71589-019-03 - Packager: Aleor Dermaceuticals Limited
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated May 9, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
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WARNINGS
This product may cause a severe allergic reaction. Symptoms may include:
- hives
- facial swelling
- wheezing/difficulty breathing
- shock
- rash
If an allergic reaction occurs, stop use and seek medical help right away.
For external use only
Do not use
- if you are allergic to any ingredient in this product
- apply only to the affected areas
- do not use in or near the eyes
- avoid applying directly inside your mouth
- do not share this product with anyone. This may spread the infection.
- your cold sore gets worse or the cold sore is not healed within 10 days
- Keep out of reach of children
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Directions
- 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
- Other information
- Inactive ingredient
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PRINCIPAL DISPLAY PANEL
Tube pack
NDC 71589-019-01
Docosanol Cream, 10%
Compare to the active ingredient in Abreva®**
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)
**This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Abreva®.
*Contains the only non-prescription cold sore medicine approved by the FDA to shorten healing time and duration of symptoms.
RETAIN THIS INSERT FOR FULL PRODUCT USES, DIRECTIONS AND WARNINGS
Manufactured for:
Aleor Dermaceuticals Ltd.,
Karakhadi, Vadodara 391450, India.
NDC 71589-019-03
Docosanol Cream, 10%
Compare to the active ingredient in Abreva®**
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)
**This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Abreva®.
*Contains the only non-prescription cold sore medicine approved by the FDA to shorten healing time and duration of symptoms.
RETAIN THIS INSERT FOR FULL PRODUCT USES, DIRECTIONS AND WARNINGS
Manufactured for:
Aleor Dermaceuticals Ltd.,
Karakhadi, Vadodara 391450, India.
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INGREDIENTS AND APPEARANCE
DOCOSANOL
docosanol creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71589-019 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:71589-019-01 1 in 1 PACKAGE 05/03/2022 1 2 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:71589-019-03 1 in 1 PACKAGE 05/03/2022 2 2 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA215839 05/03/2022 Labeler - Aleor Dermaceuticals Limited (871411532) Registrant - Aleor Dermaceuticals Limited (871411532) Establishment Name Address ID/FEI Business Operations Aleor Dermaceuticals Limited 871411532 MANUFACTURE(71589-019) , ANALYSIS(71589-019)