Label: DOCOSANOL- docosanol cream

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated April 9, 2019

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  • Active ingredient

     Docosanol  10%

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  • Purpose

    Cold sore/fever blister treatment

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  • Uses

    • treats cold sores/fever blisters on the face or lips
    • shortens healing time and duration of symptoms:

                    • tingling, pain, burning, and/or itching

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  • 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

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  • Do not use

    •  if you are allergic to any ingredient in this product
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  • When using this product

    • apply only to the 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 the infection.
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  • Stop use and ask a doctor if

    • your cold sore gets worse or the cold sore is not healed within 10 days
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  • Keep out of reach of children.

     If swallowed, get medical help or contact a Poison Control Center right away.

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  • Directions

    • adults and children 12 years or over:
      • wash hands before and after applying cream
      • apply to affected area on the 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
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  • Other information

    • store at 20° to 25°C (68° to 77°F)
    • do not freeze
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  • Inactive ingredients

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

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  • Questions?

    1-888-838-2872 between 9 am and 5 pm ET, Monday–Friday.

    Docosanol Cream, 10%
    Thank you for purchasing Docosanol Cream.
    We hope that since Docosanol Cream 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 Docosanol Cream, the more effective the medicine will be. So for best results, use Docosanol Cream at the very start of the cold sore - when you feel the first sign of the tingle, redness, bump or itch.

    Docosanol Cream is different from other over-the-counter cold sore products. Only Docosanol Cream 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 Docosanol Cream different from the over-the-counter cold sore remedies I have already been using?
    Docosanol Cream is a non-prescription cold sore medicine that can actually shorten healing time and the duration of symptoms. The sooner you start using Docosanol Cream, the sooner you can begin healing your cold sore.

    Who can use Docosanol Cream?
    Adults and children 12 years and over can use Docosanol Cream.

    How often can I apply Docosanol Cream?
    Docosanol Cream 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 Docosanol Cream?
    Yes, cosmetics such as lipstick may be applied over Docosanol Cream. 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 Docosanol Cream.

    Made in the USA
    Distributed by: Actavis Pharma, Inc.
    Parsippany, NJ 07054 USA
    Revised – March 2016

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  • PRINCIPAL DISPLAY PANEL

    Actavis

    NDC 0591-2981-35

    Compare to the active ingredient in Abreva®**

    Docosanol Cream, 10%

    Cold Sore/Fever Blister Treatment  

    Non-prescription Medicine to Shorten Healing Time*

    Cold Sore Treatment

    For Topical Use Only

    Net Wt. 2g (.07 oz)

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  • INGREDIENTS AND APPEARANCE
    DOCOSANOL 
    docosanol cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:0591-2981
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    DOCOSANOL (UNII: 9G1OE216XY) (DOCOSANOL - UNII:9G1OE216XY) DOCOSANOL 100 mg  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color WHITE Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0591-2981-35 1 in 1 PACKAGE 04/05/2019
    1 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
    ANDA ANDA208754 04/05/2019
    Labeler - Actavis Pharma, Inc. (119723554)
    Establishment
    Name Address ID/FEI Business Operations
    Actavis Laboratories UT, Inc. 079589880 LABEL(0591-2981) , MANUFACTURE(0591-2981) , PACK(0591-2981)
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