Capsaicin 0.035% cream

Capsaicin 0.035% cream is an FDA-registered drug product whose active ingredient is CAPSAICIN. It is labelled by Medcore LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 82461-417, application M017, label effective 20260507. It is one of 24 FDA drug label records sharing the active ingredient CAPSAICIN. 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 CAPSAICIN are most often described in connection with: temporarily relieves, minor aches, pains muscles, joints due, simple backache, arthritis strains. 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 due to simple backache arthritis strains sprains

Directions Adults and children 18 years and older. Apply a thin film of cream to affected area and gently rub in until fully absorbed unless treating hands. Wash hands thoroughly with soap and water immediately after application for best results. Apply 3 to 4 times daily children under 18years：ask a doctor

Warnings For external use only Read all warnings and directions before use. Test first on small area of skin. Keep out of the reach of children. If swallowed.get medical help or contact a Poison Control Center right away Do not use : On wounds or damaged skin If you are allergic to capsicum or chili peppers When using this product You may experience a burning sensation. The intensity of this reaction varies among individuals and may be severe. With regular use, this sensation generally disappears after several days. Avoid contact with the eyes, lips, nose and mucous membranes Do not tightly wrap or bandage the treated area Do not apply heat to the treated area immediately before or after use Stop use and ask a doctor if Condition worsens or does not improve after regular use Severe burning persists or blistering occurs

FDA lists 24 drug label records with CAPSAICIN 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 Capsaicin 0.035% cream used for?
Uses Temporarily relieves minor aches and pains of muscles and joints due to simple backache arthritis strains sprains

Who makes Capsaicin 0.035% cream?
Medcore LLC is the labeler of record for Capsaicin 0.035% cream. 24 FDA label records share the active ingredient CAPSAICIN, 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 Capsaicin 0.035% 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 Capsaicin 0.035% 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 CAPSAICIN?
Yes. 24 FDA drug label records list CAPSAICIN 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 Capsaicin 0.035% 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.