Label: ABREVA- docosanol cream 

  • Label RSS
  • NDC Code(s): 0135-0200-01, 0135-0200-03, 0135-0200-04
  • Packager: GlaxoSmithKline Consumer Healthcare LP
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 08/14

If you are a consumer or patient please visit this version.

  • Active ingredient

    Docosanol 10%

    Close
  • Purpose

    Cold sore/fever blister treatment

    Close
  • Uses

    treats cold sores/fever blisters on the face or lips
    shortens healing time and duration of symptoms:
    tingling, pain, burning, and/or itching
    Close
  • 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.

    Close
  • 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
    Close
  • Other information

    store at 20 o-25 oC (68 o-77 oF)
    do not freeze
    Close
  • Inactive ingredients

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

    Close
  • 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.

    Close
  • 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.

    Close
  • 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 2 g blister card
    Close
  • INGREDIENTS AND APPEARANCE
    ABREVA 
    docosanol cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL 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  
    SUCROSE DISTEARATE  
    SUCROSE STEARATE  
    Product Characteristics
    Color WHITE Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0135-0200-01 2 g in 1 TUBE
    2 NDC:0135-0200-03 2 g in 1 BOTTLE, PUMP
    3 NDC:0135-0200-04 2 in 1 PACKAGE
    3 2 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA020941 03/19/2010
    Labeler - GlaxoSmithKline Consumer Healthcare LP (828924212)
    Close