Capsaicin

Capsaicin is an FDA drug label for the active ingredient CAPSAICIN manufactured by ARI BRANDS, LLC administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231117.

Generic: CAPSAICIN

Manufacturer: ARI BRANDS, LLC

Product Type: HUMAN OTC DRUG

Route: TOPICAL

Dosage Form:

NDC: 71436-3025

Application: 505G(a)(3)

Effective: 20231117

Active Ingredients: Active ingredient Capsaicin 0.025%

Indications & Usage

Uses Temporarily relieves minor aches and pains of muscles and joints due to: • arthritis • simple backache • strains • bruises • sprains

Dosage & Administration

Directions Adults and children 18 years of age and older: Apply 1 patch to the affected area of intact skin up to 3 times a day. Do not leave patch on for more than 8 hours at a time. - Clean and dry the affected area. - Open pouch and remove one patch. - Remove any protective film and apply directly to affected area of pain. Apply immediately after removal from the protective envelope. - Wash hands with soap and water after handling the patches. - Reseal pouch containing unused patches after each use. Do not store patch outside the sealed envelope. - Fold used patches so that the adhesive side sticks to itself and safely discard used patches or pieces of cut patches where children and pets cannot get to them. Children under 18 years : Ask a physician

Contraindications

Not available.

Warnings

Warnings For external use only . Use only as directed or as directed by a health care professional Read all warnings and directions before use. Discontinue use at least one hour prior to bath, shower, or swimming; do not use immediately after bath, shower, or swimming. Do not use • On wounds, cuts, damaged or infected skin • On eyes, mouth, genitals, or any other mucous membranes Allergy Alert: if you are allergic to capsicum or chili peppers or any inactive ingredient of this product, contact a doctor before use. Whe n us ing 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 as k a physician: • If pregnant or breast feeding • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician. • If severe burning persists or blistering occurs Keep out of reach of children and pets . If swallowed, get medical help or contact a Poison Control Center immediately.

Adverse Reactions

Not available.

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