Other
Drug Facts
For external use only
TAMPER-EVIDENT: DO NOT USE IF THE SEAL ON THE TUBE IS PUNCTURED OR NOT VISIBLE
DIST. BY PUBLIX SUPER MARKETS, INC.,
3300 PUBLIX CORPORATE PARKWAY LAKELAND, FL 33811
MADE IN CANADA
Docosanol Cream
FDA Label NDC 41415-660
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Publix Super Markets Inc. for the product Docosanol (NDC 41415-660). 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 other, active ingredient, purpose, uses, allergy alert:, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
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 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 between 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?
call 1-866-923-4914
Principal Display Panel - 2 G Tube Package
NDC 41415-660-03
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