COLD SORE TREATMENT- docosanol cream

Cold Sore Treatment by

Drug Labeling and Warnings

Cold Sore Treatment by is a Otc medication manufactured, distributed, or labeled by FSA Store Inc. (Caring Mills). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 cause:

• 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 the 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 the 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 the 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, sucrose stearate

Questions or Comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM

Principal display panel

*Compare to  active ingredient Abreva®

Docosanol Cream 10%

Cold Sore/Fever Blister Treatment

• Non-prescription medicine to shorten healing time†
• Cold sore treatment
• For topical use only

NET WT

g (oz)

†Non-prescription cold sore medicine to shorten healing time and duration of symptoms.

*This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Abreva®

RETAIN THIS INSERT FOR FULL PRODUCT USES, DIRECTIONS AND WARNINGS.

Manufactured for FSA Stores Inc.

240 W. 37th St 6th Floor

New York, NY 10018

Package Label

CARING MILL Cold Sore/ Fever Blister Treatment

INGREDIENTS AND APPEARANCE

COLD SORE TREATMENT 
docosanol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81522-922
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)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81522-922-07	1 in 1 PACKAGE	10/08/2021
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	ANDA208754	10/08/2021

Labeler - FSA Store Inc. (Caring Mills) (049283340)