Medication Guide App

ABREVA

Dosage form: cream
Ingredients: DOCOSANOL 100mg in 1g
Labeler: GlaxoSmithKline Consumer Healthcare LP
NDC Code: 0135-0200

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 of the GlaxoSmithKline group of companies.

Distributed for Avanir Pharmaceuticals by

GlaxoSmithKline Consumer Healthcare, L.P.

Moon Twp, PA 15108

Made in Germany

© 2008 GlaxoSmithKline. 27675PA

Thank you for puchasing ABREVA®. We hope that since ABREVA shortens the healing time of cold sores, it helps you look and feel better faster. Please follow insert directions for proper use and refer to the information below.

You are not alone

An estimated one-in-five Americans is affected by cold sores each year. Most people who experience them get two to three cold sore outbreaks each year. Just before and during an outbreak, the cold sore infection can be easily passed on to others. It is especially important to be aware of early warning signs that a cold sore is coming, and to be sure to avoid close physical contact when you have one.

Getting to the Root of the Problem

A blister, or cluster of blisters around your mouth, is caused by the cold sore virus. After the cold sore has healed, the virus stays dormant in your body but can be reactivated by everyday triggers like stress, sunlight, extreme hot or cold weather, colds and flu, lack of sleep, or menstruation.

The Sooner, the Better

A typical cold sore outbreak can last as long as seven to ten days. The sooner you begin using ABREVA, the more effective the medicine will be. So for best results, use ABREVA at the very start of the cold sore - when you feel the first sign of the tingle, redness, bump or itch.

ABREVA is different from other over-the-counter cold sore products. Only ABREVA contains 10% docosanol, which helps to shorten the healing time of cold sores and the duration of symptoms including tingling, pain, itching and burning.

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

NDC 0135-0200-01

abreva®

DOCOSANOL 10% CREAM

Cold Sore/Fever Blister Treatment

Only FDA Approved to Shorten Healing Time*

Cold Sore Treatment

NET WT

2g (.07 oz)

© 2011 GlaxoSmithKline.

101683PA

ABREVA 
docosanol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0200
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOCOSANOL (DOCOSANOL) DOCOSANOL100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
LIGHT MINERAL OIL 
PROPYLENE GLYCOL 
WATER 
SUCROSE DISTEARATE 
SUCROSE STEARATE 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0135-0200-012 g in 1 TUBE
2NDC:0135-0200-032 g in 1 BOTTLE, PUMP
3NDC:0135-0200-042 TUBE in 1 PACKAGE
32 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02094103/19/2010
Labeler - GlaxoSmithKline Consumer Healthcare LP (828924212)

Revised: 08/2013
 
GlaxoSmithKline Consumer Healthcare LP

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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