Oralabs Cold Sore Treatment
FDA Label NDC 63645-162

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Oralabs for the product Oralabs Cold Sore Treatment (NDC 63645-162). 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

Active Ingredient

Benzocaine

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: 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.

Allergy Alert: Do not use if you are allergic to any of the ingredients in this product.

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.

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