Docosanol by Taro Pharmaceuticals U.S.A., Inc. / Taro Pharmaceuticals Inc. DOCOSANOL cream

Docosanol by

Drug Labeling and Warnings

Docosanol by is a Otc medication manufactured, distributed, or labeled by Taro Pharmaceuticals U.S.A., Inc., Taro Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

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:

• 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

• adults and children 12 years or over:
  • 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
• children under 12 years: ask a doctor

Other information

• store between 20° to 25°C (68° to 77°F)
• do not freeze

Inactive ingredients

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

Questions or comments?

call 1-866-923-4914

SPL UNCLASSIFIED SECTION

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

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

DOCOSANOL 
docosanol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51672-1406
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Docosanol (UNII: 9G1OE216XY) (Docosanol - UNII:9G1OE216XY)	Docosanol	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51672-1406-3	1 in 1 PACKAGE	10/26/2023
1		2 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 51672-1406-2	2 in 1 PACKAGE	10/26/2023
2		2 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA214454	10/26/2023

Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)

Establishment
Name	Address	ID/FEI	Business Operations
Taro Pharmaceuticals Inc.		206263295	MANUFACTURE(51672-1406)