DOCOSANOL- docosanol cream 
Cosette Pharmaceuticals, Inc.

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Docosanol Cream, 10%

Active ingredient

Docosanol 10%

Purpose

Cold sore/fever blister treatment

Uses

•    treats cold sores/fever blisters on the face or lips

•    shortens healing time and duration of symptoms:

            •    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 0713-0353-02

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

Distributed by:

Cosette Pharmaceuticals, Inc.

South Plainfield, NJ 07080

Made in India.

Code No.: GUJ/DRUGS/G/25/2216

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Pump Pack

NDC 0713-0353-62

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

Distributed by:

Cosette Pharmaceuticals, Inc.

South Plainfield, NJ 07080

Made in India.

Code No.: GUJ/DRUGS/G/25/2216

Image-4

4

DOCOSANOL 
docosanol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0713-0353
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:0713-0353-021 in 1 CARTON01/04/2024
12 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:0713-0353-621 in 1 CARTON01/04/2024
22 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21583901/04/2024
Labeler - Cosette Pharmaceuticals, Inc. (116918230)
Registrant - Alembic Pharmaceuticals Limited (650574663)
Establishment
NameAddressID/FEIBusiness Operations
Alembic Pharmaceuticals Limited871411532MANUFACTURE(0713-0353) , ANALYSIS(0713-0353)

Revised: 1/2024
Document Id: e4d903b2-6585-4e80-a58e-128fe69cf1d4
Set id: ccbb5e6d-cb85-449c-a480-28225d744f4d
Version: 1
Effective Time: 20240104
 
Cosette Pharmaceuticals, Inc.