COLD SORE TREATMENT DOCOSANOL- docosanol cream

Cold Sore Treatment Docosanol by

Drug Labeling and Warnings

Cold Sore Treatment Docosanol by is a Otc medication manufactured, distributed, or labeled by Blistex 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 (1-800-222-1222) 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 at 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?

www.blistex.com

SPL UNCLASSIFIED SECTION

Distributed by: Blistex Inc.,
P.O. Box 5392, Oak Brook, IL 60522-5392

PRINCIPAL DISPLAY PANEL - 2 g Tube Blister Pack

NDC: 10157-2124-2

Blistex®

DERMATOLOGIST RECOMMENDED

NEW

COLD SORE
TREATMENT

Docosanol Cream 10%
COLD SORE / FEVER BLISTER TREATMENT

+

FDA APPROVED MEDICINE
to Shorten Healing Time*

For Topical Use Only

NET WT. 2 g (0.07 oz)

#C010319

INGREDIENTS AND APPEARANCE

COLD SORE TREATMENT DOCOSANOL 
docosanol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10157-2124
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 DISTEARATE (UNII: 33X4X4B90S)
SUCROSE STEARATE (UNII: 274KW0O50M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10157-2124-2	1 in 1 BLISTER PACK	05/01/2025
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	ANDA217090	05/01/2025

Labeler - Blistex Inc. (005126354)

Establishment
Name	Address	ID/FEI	Business Operations
Blistex Inc.		005126354	MANUFACTURE(10157-2124)