Label: ABREVA- docosanol cream
- 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.
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- Active ingredient
Cold sore/fever blister treatmentClose
- treats cold sores/fever blisters on the face or lips
shortens healing time and duration of symptoms:
- tingling, pain, burning, and/or itching
For external use only
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.
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 doctorClose
- 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 stearateClose
- 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.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
DOCOSANOL 10% CREAM
Cold Sore/Fever Blister Treatment
Only FDA Approved to Shorten Healing Time*
Cold Sore Treatment
2g (.07 oz)
© 2014 GlaxoSmithKline.
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0200 Route of Administration TOPICAL DEA Schedule 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: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 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)