Triple 3x Max Diaper Rash

Triple 3x Max Diaper Rash is an FDA-registered drug product whose active ingredient is ZINC OXIDE. It is labelled by Advantice Health, LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 16864-061, application M016, label effective 20260514. 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: diaper rash, helps treat, protects chafed, skin due. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses helps treat and prevent diaper rash protects chafed skin due to diaper rash and helps protect from wetness

Directions change wet and soiled diapers promptly cleanse the diaper area and allow skin to dry apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or any time exposure to wet diapers may be prolonged

Warnings For external use only When using this product do not get into eyes. Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days 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.

1 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 Triple 3x Max Diaper Rash used for?
Uses helps treat and prevent diaper rash protects chafed skin due to diaper rash and helps protect from wetness

Who makes Triple 3x Max Diaper Rash?
Advantice Health, LLC is the labeler of record for Triple 3x Max Diaper Rash. 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 Triple 3x Max Diaper Rash 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 Triple 3x Max Diaper Rash 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 Triple 3x Max Diaper Rash been recalled?
1 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.