diclofenac sodium, capsaicin

FDA Drug Profile — Inflammacin

diclofenac sodium, capsaicin is listed in the FDA National Drug Code directory with 1 NDC code, marketed under brand name including Inflammacin. Available dosage form: kit.

Drug Details

Generic Name
diclofenac sodium, capsaicin
Brand Names
Inflammacin
Application Number
Sponsor
PureTek Corporation
NDC Codes
1
Dosage Forms
KIT
Routes
N/A
Active Ingredients
N/A

Indications and Usage

1 INDICATIONS AND USAGE Diclofenac sodium topical solution, USP is indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s) (1). Diclofenac sodium topical solution is a nonsteroidal anti-inflammatory drug indicated for the treatment of signs and symptoms of osteoarthritis of the knee(s). ( 1 ) 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 cause a 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. Discontinue use and consult a doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days. Stop using and get immediate medical attention if experience burning, pain, swelling or blistering of the skin. Rare cases of severe burning or blistering have been reported. 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.