Active Ingredient
Benzocaine
Walgreens Cold Sore Treatment
FDA Label NDC 0363-3191
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Walgreens for the product Walgreens Cold Sore Treatment (NDC 0363-3191). 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, keep out of reach of children, uses, warnings, directions, inactive ingredients, 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/Pain Reliever
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.
Uses
For treatment of cold sores/fever blisters on the face and lips
Warnings
For external use only: Allergy Alert: Do not use this product if you have a history of allergy to local anesthetics such as procaine, butocaine, benzocaine, or other “caine: anesthetics.
Do not use in the eyes or apply over large areas of the body. In case of deep or puncture wounds, animal bites or serious burns, consult a physician.
When using this product avoid contact with eyes. Use only as directed.
Stop use and ask a doctor if the condition gets worse. Do not use longer than 1 week unless directed by a doctor.
Directions
Clean the affected
Adults and children 2 years of age and older: Apply to affected area not more than 4 times daily
Children under 2 years of age: consult a physician
Rub in gently – Applies clear
Wash hands before and after applying cream
Do not share this product with anyone
Inactive Ingredients
Benzyl Alcohol, Docosanol, Mineral Oil, Propylene Glycol, Sucrose Stearate, Tocopherol, Water.
* Please review the disclaimer below.
