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 Cvs Pharmacy, 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.
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 you are allergic to any ingredient in 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.
- your cold sore gets worse or the cold sore is not healed within 10 days
- adults and children 12 years or over:
- children under 12 years: ask a doctor
If an allergic reaction occurs, stop use and seek medical help right away.
For external use only
Do not use
When using this product
Stop use and ask a doctor if
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
• 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
Other Information
- store at 20° to 25°C (68° to 77°F)
- do not freeze
Inactive Ingredient
benzyl alcohol, light mineral oil, propylene glycol, purified water, sucrose distearate, sucrose stearate
Questions Or Comments?
Call 1-866-210-9797 Monday-Friday 9AM-6PM EST
Principal Display Panel
PUMP PACK
NDC 51316-763-64
Docosanol Cream, 10%
Compare to the active ingredient in Abreva®*
Cold Sore/Fever Blister Treatment
Non-prescription Medicine to Shorten Healing Time**
Cold Sore Treatment
For Topical Use Only
NET WT 2g (0.07 oz)
*This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Abreva®.
**Contains the only non-prescription cold sore medicine approved by the FDA to shorten healing time and duration of symptoms.
RETAIN THIS INSERT FOR FULL PRODUCT USES, DIRECTIONS AND WARNINGS
Distributed by:
CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2023 CVS/Pharmacy
CVS.com® 1-800-SHOP CVS V-38892
Made in India.
Mfg. License No.: G/25/2216
PRINCIPAL DISPLAY PANEL
TUBE PACK
NDC 51316-763-04
Docosanol Cream, 10%
Compare to the active ingredient in Abreva®*
Cold Sore/Fever Blister Treatment
Non-prescription Medicine to Shorten Healing Time**
Cold Sore Treatment
For Topical Use Only
NET WT 2g (0.07 oz)
*This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Abreva®.
**Contains the only non-prescription cold sore medicine approved by the FDA to shorten healing time and duration of symptoms.
RETAIN THIS INSERT FOR FULL PRODUCT USES, DIRECTIONS AND WARNINGS
Distributed by:
CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2023 CVS/Pharmacy
CVS.com® 1-800-SHOP CVS V-38892
Made in India.
Mfg. License No.: G/25/2216
PRINCIPAL DISPLAY PANEL
TUBE PACK
NDC 51316-763-02
Docosanol Cream, 10%
Compare to the active ingredient in Abreva®*
Cold Sore/Fever Blister Treatment
Non-prescription Medicine to Shorten Healing Time**
Cold Sore Treatment
For Topical Use Only
NET WT 2g (0.07 oz)
*This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Abreva®.
**Contains the only non-prescription cold sore medicine approved by the FDA to shorten healing time and duration of symptoms.
RETAIN THIS INSERT FOR FULL PRODUCT USES, DIRECTIONS AND WARNINGS
Distributed by:
CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895
© 2023 CVS/Pharmacy
CVS.com® 1-800-SHOP CVS V-38892
Made in India.
Mfg. License No.: G/25/2216
* Please review the disclaimer below.