Barrier Cream

Barrier Cream is an FDA-registered drug product whose active ingredient is ZINC OXIDE. It is labelled by Avasol LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 58518-040, application M016, label effective 20230515. It is one of 404 FDA drug label records sharing the active ingredient ZINC OXIDE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing ZINC OXIDE are most often described in connection with: temporarily protects, prevents chafing, helps seal, relieve minor, skin irritation, itching due, rashes chafed, chapped cracked. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses Temporarily protects the skin and prevents chafing, blisters and irritation and helps seal out wetness. Helps prevent and helps relieve minor skin irritation and itching due to rashes, chafed, chapped, cracked, or windburned skin.

Directions Apply liberally, directly on skin as needed. Safe to apply to prosthetics, protective equipment, etc.

Warnings For external use only Avoid contact with eyes. Rinse with water to remove. Stop use and ask a doctor Condition worsens symptoms last for more than 7 days or clear up and occur again within a few days Do not use: if allergic to ingredients. on deep or puncture wounds on animal bites •on serious burns. Test small area first. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

FDA lists 404 drug label records with ZINC OXIDE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

4 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is Barrier Cream used for?
Uses Temporarily protects the skin and prevents chafing, blisters and irritation and helps seal out wetness. Helps prevent and helps relieve minor skin irritation and itching due to rashes, chafed, chapped, cracked, or windburned skin.

Who makes Barrier Cream?
Avasol LLC is the labeler of record for Barrier Cream. 404 FDA label records share the active ingredient ZINC OXIDE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Barrier Cream come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Barrier Cream prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing ZINC OXIDE?
Yes. 404 FDA drug label records list ZINC OXIDE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Barrier Cream been recalled?
4 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.