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ABREVA (GlaxoSmithKline Consumer Healthcare LP)

Available Formats

Dosage Form Package Information Links
CREAM 2 g in 1 TUBE (0135-0200-01) Label Information
CREAM 2 g in 1 BOTTLE, PUMP (0135-0200-03) Label Information
CREAM 2 TUBE in 1 PACKAGE (0135-0200-04) > 2 g in 1 TUBE Label Information

Complete ABREVA Information

  • 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 20 o-25 oC (68 o-77 oF)
    • 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

    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



    Cold Sore/Fever Blister Treatment

    Only FDA Approved to Shorten Healing Time*

    Cold Sore Treatment

    NET WT

    2g (.07 oz)

    © 2014 GlaxoSmithKline.


    Abreva 2g print card

    docosanol cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0200
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color WHITE Score     
    Shape Size
    Flavor Imprint Code
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0135-0200-01 2 g in 1 TUBE; Type 0: Not a Combination Product 03/19/2010
    2 NDC:0135-0200-03 2 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 03/19/2010
    3 NDC:0135-0200-04 2 in 1 PACKAGE 03/19/2010
    3 2 g in 1 TUBE; Type 0: Not a Combination Product
    4 NDC:0135-0200-05 2 in 1 PACKAGE 07/06/2017
    4 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
    NDA NDA020941 03/19/2010
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)