DOCOSANOL- docosanol cream 
Taro Pharmaceuticals U.S.A., Inc.

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Docosanol

Drug Facts

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:

  • 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

When using this product

  • apply only to 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 infection.

Stop use and ask a doctor if

  • your cold sore gets worse or the cold sore is not healed within 10 days

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 and sucrose stearate

Questions or comments?

call 1-866-923-4914

TAMPER-EVIDENT: DO NOT USE IF THE SEAL ON THE TUBE IS PUNCTURED OR NOT VISIBLE

Dist. by: Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532

PRINCIPAL DISPLAY PANEL - 2 g Tube Package

NDC 51672-1406-3

Compare to the active
ingredient in Abreva®*

Docosanol
Cream 10%

Cold Sore
Fever Blister
Treatment

Cold Sore
Treatment

Only FDA
Approved
Medicine to
Shorten
Healing Time✝

For Topical Use Only

Net Wt. 2 g (0.07 oz)

Dist. by: Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532 Made in Canada

PRINCIPAL DISPLAY PANEL - 2 g Tube Package
DOCOSANOL 
docosanol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51672-1406
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 stearate (UNII: 274KW0O50M)  
sucrose distearate (UNII: 33X4X4B90S)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51672-1406-31 in 1 PACKAGE10/26/2023
12 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:51672-1406-22 in 1 PACKAGE10/26/2023
22 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA21445410/26/2023
Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceuticals Inc.206263295MANUFACTURE(51672-1406)

Revised: 11/2023
Document Id: 6cb00624-2c0b-47e9-9d6d-38bbf7292c4f
Set id: 5079b009-7f34-4d34-8f01-821365f04ca2
Version: 5
Effective Time: 20231116
 
Taro Pharmaceuticals U.S.A., Inc.