OsmoFlex

OsmoFlex is an FDA-registered drug product whose active ingredient is MENTHOL. It is labelled by Sarati International, Inc. taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 67676-101, application M017, label effective 20231027. It is one of 193 FDA drug label records sharing the active ingredient MENTHOL. 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 MENTHOL are most often described in connection with: temporary relief, minor aches, pains muscles, joints associated, simple backache, arthritis strains, bruises sprains. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses For the temporary relief of minor aches and pains of muscles and joints associated with simple backache arthritis strains bruises sprains

Directions adults and children 12 years of age and older, apply to affected area not more than 3 to 4 times daily children under 12 years of age, ask a doctor massage a generous amount to affected area until absorbed.

Warnings For External Use Only

FDA lists 193 drug label records with MENTHOL 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 OsmoFlex used for?
Uses For the temporary relief of minor aches and pains of muscles and joints associated with simple backache arthritis strains bruises sprains

Who makes OsmoFlex?
Sarati International, Inc. is the labeler of record for OsmoFlex. 193 FDA label records share the active ingredient MENTHOL, 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 OsmoFlex 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 OsmoFlex 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 MENTHOL?
Yes. 193 FDA drug label records list MENTHOL 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 OsmoFlex 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.