Capsaicin Cream

Capsaicin Cream is an FDA-registered drug product whose active ingredient is CAPSAICIN. It is labelled by Trifecta Pharmaceuticals USA LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 69396-180, application M017, label effective 20260812. 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: temporary relief, minor aches, pains muscles, joints associated, arthritis simple, backache strains, sprains bruises. 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: Arthritis Simple Backache Strains Sprains Bruises

Directions Adults and Children over 18 years: Apply to affected area Massage into the painful area until thoroughly absorbed Repeat as necessary but not more than 3 to 4 times daily WASH HANDS WITH SOAP AND WATER AFTER APPLYING Children 18 years and younger: Ask a doctor

Warnings For external use only: TEST FIRST ON SMALL AREA OF SKIN. When using this product: Use only as directed Do not apply to wounds, damaged, broken or irritated skin Do not use if you are allergic to capsicum or chilli peppers Avoid contact with the eyes or mucous membranes A slight burning sensation may occur upon application, but generally disappears after several days If severe burning occurs, discontinue use Do not expose the treated area to heat or direct sunlight Do not bandage Do not use with heating pad Do not use at the same time as other topical analgesics

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.

1 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 Capsaicin Cream used for?
Uses For the temporary relief of minor aches and pains of muscles and joints associated with: Arthritis Simple Backache Strains Sprains Bruises

Who makes Capsaicin Cream?
Trifecta Pharmaceuticals USA LLC is the labeler of record for Capsaicin 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 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 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 Cream been recalled?
1 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.