FDA Label for Docosanol
View Indications, Usage & Precautions
Docosanol Product Label
The following document was submitted to the FDA by the labeler of this product Care One (retail Business Services, Llc.). 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.
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 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.
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 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
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, sucrose stearate
Questions Or Comments?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Principal Display Panel
Compare to active ingredient in Abreva®†
Docosanol Cream 10%
COLD SORE TREATMENT
Non-prescription
medicine to shorten healing time.*
For topical use only
NET WT 2g (0.07 OZ)
†This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Abreva®.
*Non-prescription cold sore medicine to shorten healing time and duration of symptoms.
RETAIN THIS INSERT FOR FULL PRODUCT USES, DIRECTION AND WARNINGS.
DISTRIBUTED BY:
FOODHOLD U.S.A., LLC
LANDOVER, MD 20785
Package Label
CARE ONE Docosanol Cream 10% Cold Sore Treatment
* Please review the disclaimer below.