Docosanol by Cardinal Health (Leader) 70000 DOCOSANOL cream

Docosanol by

Drug Labeling and Warnings

Docosanol by is a Otc medication manufactured, distributed, or labeled by Cardinal Health (Leader) 70000. 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 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

COMPARE TO ABREVA® active ingredient†

Docosanol

Cream, 10% | Cold Sore / Fever Blister Treatment

Non-Prescription

Medicine to Shorten

Healing Time*

For Topical Use Only

NET WT 2 g (0.07 oz)

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

* Non-prescription cold sore medicine to shorten healing time and duration of symptpms.

RETAIN THIS INSERT FOR FULL PRODUCT USES, DIRECTIONS AND WARNINGS

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

www.myleader.com  1-800-200-6313

 

Package Label

LEADER Docosanol Cream, 10%

INGREDIENTS AND APPEARANCE

DOCOSANOL 
docosanol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0517
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: 70000-0517-1	1 in 1 PACKAGE	09/17/2019
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	09/17/2019

Labeler - Cardinal Health (Leader) 70000 (097537435)