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Name:Abreva
Manufacturer:Glaxosmithkline Consumer Healtcare Lp
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

ABREVA - docosanol cream 
GlaxoSmithKline Consumer Healtcare LP

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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

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 at 20o-25oC (68o-77oF)
  • do not freeze

Inactive ingredients

benzyl alcohol, light mineral oil, propylene glycol, purified water, sucrose distearate, sucrose stearate

Questions or comments?

call toll-free 1-877-709-3539 (English/Spanish) weekdays

visit us at www.abreva.com

If you are not completely satisfied, save receipt and remaining product, and call us at 1-877-709-3539 weekdays.

Abreva and logo design and overall design elements are trademarks owned by GlaxoSmithKline.

Distributed for Avanir Pharmaceuticals by

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Twp, PA 15108

Made in Germany

© 2008 GlaxoSmithKline. 27675PA

Frequently Asked Questions:

How is ABREVA different from the over-the-counter cold sore remedies I have already been using?

Abreva is the only FDA approved non-prescription cold sore medicine that can actually shorten healing time and the duration of symptoms. The sooner you start using ABREVA, the sooner you can begin healing your cold sore.

Who can use ABREVA?

Adults and children 12 years and over can use ABREVA.

How often can I apply ABREVA?

ABREVA should be used five times a day until the cold sore is healed. Apply it directly to the cold sore at the first sign of a tingle, redness, bump or itch for best results.

Can I apply cosmetics on top of ABREVA?

Yes, cosmetics such as lipstick may be applied over ABREVA. However, use a separate applicator, like a cotton swab, to apply cosmetics over an unhealed cold sore to avoid spreading the infection. For best results, remove any cosmetics prior to applying ABREVA.

Principal Display Panel

abreva®

DOCOSANOL 10% CREAM

Cold Sore/Fever Blister Treatment

Only FDA Approved to Shorten Healing Time*

Cold Sore Treatment

PHARMACIST RECOMMENDED #1

NET WT

2g (.07 oz)

abreva 2 g label


ABREVA 
docosanol cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0200
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DOCOSANOL (DOCOSANOL) DOCOSANOL 100 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL  
LIGHT MINERAL OIL  
PROPYLENE GLYCOL  
WATER  
Product Characteristics
Color WHITE Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0135-0200-01 2 g in 1 TUBE None
2 NDC:0135-0200-03 2 g in 1 BOTTLE, PUMP None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020941 03/19/2010

Labeler - GlaxoSmithKline Consumer Healtcare LP (091328625)

Revised: 03/2010 GlaxoSmithKline Consumer Healtcare LP



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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