DOCOSANOL- docosanol cream 
Alembic Pharmaceuticals Inc.

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Docosanol Cream, 10%

Active ingredient

Docosanol 10%

Purpose

Cold sore/fever blister treatment

Uses

        •    tingling, pain, burning, and/or itching

Warnings

Allergy Alert

This product may cause a severe allergic reaction. Symptoms may include:

If an allergic reaction occurs, stop use and seek medical help right away.

For external use only

Do not use

When using this product

Stop use and ask a doctor if

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

       •   wash hands before and after applying cream

       •   apply to affected area on 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

Other information

Inactive ingredients

benzyl alcohol, light mineral oil, propylene glycol, purified water, sucrose distearate, sucrose stearate

Questions or comments?

Call 1-866-210-9797 Monday-Friday 9AM-6PM EST

Principal Display Panel

Tube Pack

NDC 62332-682-01

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:

Alembic Pharmaceuticals, Inc.

Bedminster, NJ 07921, USA

Made in India.

tube pack

Pump Pack

NDC 62332-682-03

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:

Alembic Pharmaceuticals, Inc.

Bedminster, NJ 07921, USA

Made in India.

pump pack
DOCOSANOL 
docosanol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62332-682
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCOSANOL (UNII: 9G1OE216XY) (DOCOSANOL - UNII:9G1OE216XY) DOCOSANOL100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62332-682-011 in 1 PACKAGE05/03/2022
12 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:62332-682-031 in 1 PACKAGE05/03/2022
22 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21583905/03/2022
Labeler - Alembic Pharmaceuticals Inc. (079288842)
Registrant - Alembic Pharmaceuticals Limited (871411532)
Establishment
NameAddressID/FEIBusiness Operations
Alembic Pharmaceuticals Limited871411532MANUFACTURE(62332-682) , ANALYSIS(62332-682)

Revised: 12/2023
Document Id: 00ec9cfd-4b08-477f-852d-07c753f21a5c
Set id: 86450000-1810-4739-9801-59beb7c19e67
Version: 4
Effective Time: 20231222
 
Alembic Pharmaceuticals Inc.