COLD SORE FEVER BLISTER TREATMENT- docosanol cream

Cold Sore Fever Blister Treatment by

Drug Labeling and Warnings

Cold Sore Fever Blister Treatment by is a Otc medication manufactured, distributed, or labeled by Strategic Sourcing Services LLC. 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 include:

• hives
• facial swelling
• wheezing/difficulty
• 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 (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 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 1-833-358-6431 Monday-Friday 9am to 7pm  EST

Principal Display Panel

COMPARE TO ABREVA® ACTIVE INGREDIENT*

Docosanol Cream, 10%

COLD SORE / FEVER BLISTER TREATMENT

• Only FDA Approved Medicine to Shorten Healing Time†
• Cold sore treatment

NET WT 2 g (0.07 oz)

*This product is not manufactured or distributed by GlaxoSmithKline Consumer Healthcare Holdings (US) LLC, distributor of Abreva®.

†Docosanol Cream, 10% contain the only OTC medicine approved by the FDA to shorten healing time and duration of symptoms.

RETAIN THIS INSERT FOR FULL PRODUCT USES, DIRECTIONS AND WARNINGS

Distributed by: McKesson Corp., via Strategic

Sourcing Sevices LLC. Memphis, TN 38141

Package Label

FOSTER & THRIVE Cold Sore Fever Blister Treatment

INGREDIENTS AND APPEARANCE

COLD SORE FEVER BLISTER TREATMENT 
docosanol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70677-1255
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 (HLB 5) (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: 70677-1255-1	1 in 1 PACKAGE	01/14/2024	12/31/2027
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	ANDA212385	01/14/2024	12/31/2027

Labeler - Strategic Sourcing Services LLC (116956644)