Docosanol by Publix Super Markets Inc. / Sun Pharma Canada Inc. DOCOSANOL cream

Docosanol by

Drug Labeling and Warnings

Docosanol by is a Otc medication manufactured, distributed, or labeled by Publix Super Markets Inc., Sun Pharma Canada 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 PUBLIX SUPER MARKETS, INC.,

3300 PUBLIX CORPORATE PARKWAY LAKELAND, FL 33811

MADE IN CANADA

PRINCIPAL DISPLAY PANEL - 2 g Tube Package

NDC: 41415-660-03

INGREDIENTS AND APPEARANCE

DOCOSANOL 
docosanol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41415-660
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: 41415-660-03	1 in 1 PACKAGE	07/15/2025
1		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	07/15/2025

Labeler - Publix Super Markets Inc. (006922009)

Establishment
Name	Address	ID/FEI	Business Operations
Sun Pharma Canada Inc.		243339023	manufacture(41415-660)