FDA Label for Cold Sore Treatment Docosanol
View Indications, Usage & Precautions
Cold Sore Treatment Docosanol Product Label
The following document was submitted to the FDA by the labeler of this product Blistex Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Distributed by: Blistex Inc.,
P.O. Box 5392, Oak Brook, IL 60522-5392
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
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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) 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 20° to 25°C (68° to 77°F).
- do not freeze
Inactive Ingredients
benzyl alcohol, light mineral oil, propylene glycol, purified water, sucrose distearate and sucrose stearate
Questions Or Comments?
www.blistex.com
Principal Display Panel - 2 G Tube Blister Pack
NDC 10157-2124-2
Blistex®
DERMATOLOGIST RECOMMENDED
NEW
COLD SORE
TREATMENT
Docosanol Cream 10%
COLD SORE / FEVER BLISTER TREATMENT
+
FDA APPROVED MEDICINE
to Shorten Healing Time*
For Topical Use Only
NET WT. 2 g (0.07 oz)
#C010319
* Please review the disclaimer below.
