Cetaphil Baby Soothe and Protect Cream

Cetaphil Baby Soothe and Protect Cream is an FDA-registered drug product whose active ingredient is ALLANTOIN. It is labelled by Galderma Laboratories, L.P. taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 0299-4103, application M016, label effective 20231122. It is one of 9 FDA drug label records sharing the active ingredient ALLANTOIN. 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 ALLANTOIN are most often described in connection with: temporarily protects, minor cuts, scrapes burns, helps prevent, relieve chafed, chapped cracked, drying effects, cold weather. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses Temporarily protects minor: ●cuts ●scrapes ●burns ■helps prevent and temporarily protects and helps relieve chafed, chapped or cracked skin ■Helps protect from the drying effects of wind and cold weather.

Directions ■Apply as needed

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. Do not use on ■Deep or puncture wounds ■Animal bites ■Serious burns Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

FDA lists 9 drug label records with ALLANTOIN 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.

2 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 Cetaphil Baby Soothe and Protect Cream used for?
Uses Temporarily protects minor: ●cuts ●scrapes ●burns ■helps prevent and temporarily protects and helps relieve chafed, chapped or cracked skin ■Helps protect from the drying effects of wind and cold weather.

Who makes Cetaphil Baby Soothe and Protect Cream?
Galderma Laboratories, L.P. is the labeler of record for Cetaphil Baby Soothe and Protect Cream. 9 FDA label records share the active ingredient ALLANTOIN, 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 Cetaphil Baby Soothe and Protect 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 Cetaphil Baby Soothe and Protect 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 ALLANTOIN?
Yes. 9 FDA drug label records list ALLANTOIN 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 Cetaphil Baby Soothe and Protect Cream been recalled?
2 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.