COLD SORE FEVER BLISTER TREATMENT- docosanol cream 
Topco Associates

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Docosanol Cream, 10%

Active ingredient

 Docosanol  10%

Purpose

Cold sore/fever blister treatment

Uses

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

Other information

Inactive ingredients

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

Questions or comments?

Call toll free 1-888-423-0139

Principal Display Panel

†COMPARE TO THE ACTIVE INGREDIENT IN ABREVA®

Cold Sore Treatment

COLD SORE/FEVER BLISTER TREATMENT

DOCOSANOL CREAM, 10%

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 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC, distributor of Abreva®.

RETAIN THIS INSERT FOR FULL PRODUCT USES, DIRECTIONS AND WARNINGS

DISTRIBUTED BY

TOPCO ASSOCIATES LLC

ITASCA, IL 60143

Package Label

Docosanol 10%

TOPCARE HEALTH Cold Sore Fever Blister Treatment

COLD SORE FEVER BLISTER TREATMENT 
docosanol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76162-818
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:76162-818-071 in 1 PACKAGE12/31/2023
12 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21238512/31/2023
Labeler - Topco Associates (006935977)

Revised: 4/2024
Document Id: 49c1aab8-2370-4e50-8a74-aa74ead0c341
Set id: 73348ce7-5b08-49ad-ba59-6f54887f819b
Version: 2
Effective Time: 20240405
 
Topco Associates