Active Ingredient
Docosanol 10%
Cold Sore Treatment Cream
FDA Label NDC 81522-922
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Fsa Store Inc. (caring Mills) for the product Cold Sore Treatment (NDC 81522-922). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 cause:
- 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
Principal Display Panel
*Compare to active ingredient Abreva®
Docosanol Cream 10%
Cold Sore/Fever Blister Treatment
- Non-prescription medicine to shorten healing time†
- Cold sore treatment
- For topical use only
NET WT
g (oz)
†Non-prescription cold sore medicine to shorten healing time and duration of symptoms.
*This product is not manufactured or distributed by GSK Consumer Healthcare, distributor of Abreva®
RETAIN THIS INSERT FOR FULL PRODUCT USES, DIRECTIONS AND WARNINGS.
Manufactured for FSA Stores Inc.
240 W. 37th St 6th Floor
New York, NY 10018
Package Label
CARING MILL Cold Sore/ Fever Blister Treatment
* Please review the disclaimer below.
