SOMBRA WARM THERAPY

SOMBRA WARM THERAPY is an FDA-registered drug product whose active ingredient is MENTHOL CAMPHOR. It is labelled by SOMBRA COSMETICS INC. taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 61577-3100, application M017, label effective 20260424. It is one of 2 FDA drug label records sharing the active ingredient MENTHOL CAMPHOR. 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 CAMPHOR are most often described in connection with: temporarily relieves, minor aches, pains muscles, joints associated, arthritis simple. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses Temporarily relieves minor aches and pains of muscles and joints associated with: arthritis, simple backaches

Directions adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily, rub in thoroughly until gel is absorbed, children under 2 years of age : consult a doctor.

Warnings For external use only . Do not use on wounds or damaged skin. When using this product : avoid bandaging tightly, avoid contact with eyes, keep out of reach of children . Stop use and ask doctor if : condition worsens, symptoms persist for more than 7 days, clear up and occur again within a few days.

FDA lists 2 drug label records with MENTHOL CAMPHOR 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 SOMBRA WARM THERAPY used for?
Uses Temporarily relieves minor aches and pains of muscles and joints associated with: arthritis, simple backaches

Who makes SOMBRA WARM THERAPY?
SOMBRA COSMETICS INC. is the labeler of record for SOMBRA WARM THERAPY. 2 FDA label records share the active ingredient MENTHOL CAMPHOR, 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 SOMBRA WARM THERAPY 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 SOMBRA WARM THERAPY 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 CAMPHOR?
Yes. 2 FDA drug label records list MENTHOL CAMPHOR 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 SOMBRA WARM THERAPY 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.