Friday, October 28, 2016

Abreva Drug Facts



docosanol

Dosage Form: cream
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 owned by GlaxoSmithKline.


Distributed for Avanir Pharmaceuticals by


GlaxoSmithKline Consumer Healthcare, L.P.


Moon Twp, PA 15108


Made in Germany


© 2008 GlaxoSmithKline. 27675PA



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


abreva®


DOCOSANOL 10% CREAM


Cold Sore/Fever Blister Treatment


Only FDA Approved to Shorten Healing Time*


Cold Sore Treatment


PHARMACIST RECOMMENDED #1


NET WT


2g (.07 oz)










ABREVA 
docosanol  cream










Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)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 


















Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains      














Packaging
#NDCPackage DescriptionMultilevel Packaging
10135-0200-012 g In 1 TUBENone
20135-0200-032 g In 1 BOTTLE, PUMPNone










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02094103/19/2010


Labeler - GlaxoSmithKline Consumer Healtcare LP (091328625)
Revised: 03/2010GlaxoSmithKline Consumer Healtcare LP




More Abreva Drug Facts resources


  • Abreva Drug Facts Side Effects (in more detail)
  • Abreva Drug Facts Use in Pregnancy & Breastfeeding
  • Abreva Drug Facts Support Group
  • 6 Reviews for Abreva Drug Facts - Add your own review/rating


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