Label: ABREVA- docosanol cream

  • NDC Code(s): 0135-0200-01, 0135-0200-03, 0135-0200-04, 0135-0200-05
  • Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 5, 2020

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • 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 breathing
    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 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

  • Additional information

    *ABREVA contains the only OTC medicine approved by the FDA to shorten healing time and duration of symptoms.

    Retain this insert for full product uses, directions and warnings.

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

    Trademarks are owned by or licensed to the GSK group of companies.

    Distributed for Avanir Pharmaceuticals by

    GSKConsumer Healthcare

    Warren, NJ 07059, Made in Germany

    ©2020 GSK or licensor.

    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.

    Frequently Asked Questions:

    How is ABREVA different from the Over-The-Counter cold sore remedies I have already been using?

    Abreva contains 10% docosanol, the only FDA approved non-prescription ingredient that can actually shorten healing time and the duration of symptoms including tingling, pain, itching, and burning. The sooner you start using ABREVA, the sooner you can begin healing your cold sore. No other Over-The-Counter cold sore product heals your cold sore faster.

    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.

    For More Information:

     
    Call us at 1-877-709-3539

    Abreva
    DOCOSANOL 10% CREAM
    COLD SORE/FEVER BLISTER TREATMENT

  • Principal Display Panel

    NDC 0135-0200-01

    abreva

    DOCOSANOL 10% CREAM

    gsk

    Cold Sore/Fever Blister Treatment

    Cold Sore Treatment

    Beauty Unaltered

    NET WT

    2g (0.07 oz)

    1000771

    Abreva 2g tube print card
  • INGREDIENTS AND APPEARANCE
    ABREVA 
    docosanol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCOSANOL (UNII: 9G1OE216XY) (DOCOSANOL - UNII:9G1OE216XY) DOCOSANOL100 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0200-012 g in 1 TUBE; Type 0: Not a Combination Product03/19/2010
    2NDC:0135-0200-032 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/19/2010
    3NDC:0135-0200-042 in 1 PACKAGE03/19/201002/29/2020
    32 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:0135-0200-052 in 1 PACKAGE07/06/2017
    42 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02094103/19/2010
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)