DOCOSANOL- docosanol cream 
CVS Pharmacy, 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 ingredient

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

PUMP PACK

NDC 51316-763-64

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:

CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2023 CVS/Pharmacy

CVS.com® 1-800-SHOP CVS V-38892

Made in India.

Mfg. License No.: G/25/2216

pump backer card

PRINCIPAL DISPLAY PANEL

TUBE PACK

NDC 51316-763-04

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:

CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2023 CVS/Pharmacy

CVS.com® 1-800-SHOP CVS V-38892

Made in India.

Mfg. License No.: G/25/2216

tube backer card

PRINCIPAL DISPLAY PANEL

TUBE PACK

NDC 51316-763-02

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:

CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

© 2023 CVS/Pharmacy

CVS.com® 1-800-SHOP CVS V-38892

Made in India.

Mfg. License No.: G/25/2216

tube backer label
DOCOSANOL 
docosanol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51316-763
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:51316-763-041 in 1 PACKAGE01/06/2023
12 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:51316-763-641 in 1 PACKAGE01/06/2023
22 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
3NDC:51316-763-021 in 1 PACKAGE01/06/2023
32 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21583901/06/2023
Labeler - CVS Pharmacy, Inc. (062312574)
Registrant - Alembic Pharmaceuticals Limited (650574663)
Establishment
NameAddressID/FEIBusiness Operations
Contract Packaging Resources, Inc.960203917PACK(51316-763)
Establishment
NameAddressID/FEIBusiness Operations
Alembic Pharmaceuticals Limited871411532MANUFACTURE(51316-763) , ANALYSIS(51316-763)

Revised: 12/2023
Document Id: 52bca09e-9c76-4e31-b5de-13b5db970657
Set id: 336b515c-5e7b-4ece-a94f-f8d8e9ce6a7b
Version: 3
Effective Time: 20231218
 
CVS Pharmacy, Inc.