Capsaicin 0.035% Cream

FDA Drug Profile — Capsaicin 0.035% Cream

Drug Details

Generic Name
Capsaicin 0.035% Cream
Brand Names
Capsaicin 0.035% Cream
Application Number
M017
Sponsor
Puretekcorp
NDC Codes
1
Dosage Forms
CREAM
Routes
TOPICAL
Active Ingredients
CAPSAICIN

Indications and Usage

Uses for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains and sprains.

Warnings

Warnings For external use only • This is not a face cream. Do not apply to the face. • Do not use if allergic to chili peppers or if past allergic reaction to capsaicin. • Do not apply to wounds or damaged , broken, sunburned, chapped or irritated skin. • Do not bandage tightly. • Do not apply within 1 hour before or after bath, shower, hot tub, sauna or vigorous exercise. Warm water, perspiration or open pores can intensify the impact of this product and burning sensation. • Do not use with heating pad, hot water bottle or other source of heat. Doing so can increase risk of serious burns. When using this product Do not get into eyes and avoid contact with other mucous membranes. If contact occurs or if pain, discomfort or skin redness occurs, continually rinse with cool water and seek medical help. If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use and consult a doctor. If pregnant, breast-feeding or any medical conditions exist, ask a health professional before use. Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away. If inhaled, remove to fresh air. If breathing is difficult, get medical attention immediately.