Claravie Skin Repair Cream

Claravie Skin Repair Cream is an FDA-registered drug product whose active ingredient is DIMETHICONE. It is labelled by Gentell LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 61554-303, application M016, label effective 20260819. It is one of 30 FDA drug label records sharing the active ingredient DIMETHICONE. 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 DIMETHICONE are most often described in connection with: temporarily protects, helps relieve, chafed chapped, cracked skin, 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 and helps relieve chafed chapped or cracked skin Helps protect from the drying effects of wind and cold weather

Apply as needed.

Warnings For external use only When using this product do not use near or get into the 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

FDA lists 30 drug label records with DIMETHICONE 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.

What is Claravie Skin Repair Cream used for?
Uses Temporarily protects and helps relieve chafed chapped or cracked skin Helps protect from the drying effects of wind and cold weather

Who makes Claravie Skin Repair Cream?
Gentell LLC is the labeler of record for Claravie Skin Repair Cream. 30 FDA label records share the active ingredient DIMETHICONE, 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 Claravie Skin Repair 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 Claravie Skin Repair 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 DIMETHICONE?
Yes. 30 FDA drug label records list DIMETHICONE 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 Claravie Skin Repair Cream been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

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.