Camphor, Capsaicin, Menthol

FDA Drug Profile — SATOHAP COOL and HOT, Satohap Cool and Hot Pads, Biofreeze Triple Target Gel, Biofreeze Triple Target Roll-On

Camphor, Capsaicin, Menthol is listed in the FDA National Drug Code directory with 4 NDC codes, marketed under brand names including SATOHAP COOL and HOT, Satohap Cool and Hot Pads, Biofreeze Triple Target Gel. Available dosage forms: patch, gel.

Drug Details

Generic Name
Camphor, Capsaicin, Menthol
Brand Names
SATOHAP COOL and HOT, Satohap Cool and Hot Pads, Biofreeze Triple Target Gel, Biofreeze Triple Target Roll-On
Application Number
M017
Sponsor
Sato Pharmaceuticals Co., Ltd.
NDC Codes
4
Dosage Forms
PATCH, GEL
Routes
TOPICAL
Active Ingredients
CAMPHOR (SYNTHETIC), CAPSAICIN, LEVOMENTHOL, CAMPHOR (NATURAL), MENTHOL, UNSPECIFIED FORM

Indications and Usage

Uses For the temporary relief of minor aches and pains of muscles and joints due to: simple backache arthritis strains bruises sprains

Warnings

Warnings For external use only Do not use on irritated or damaged skin on wounds Ask a doctor or pharmacist before use if you have any concerns about using this product When using this product avoid contact with the eyes or mucus membranes do not bandage tightly do not apply heat to the area in the form of heating pads, hot water bottles, or lamps (doing so increases the risk of serious burns) Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days symptoms clear up and occur again within a few days excessive irritation of the skin develops nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs. you feel actual pain or experience blistering or burning after application (it is normal to feel a warming or cooling sensation) when using for pain or arthritis: pain persists for more than 10 days redness is present in conditions affecting children under 12 years of age Report any unexpected side effects from the use of this product to the FDA MedWatch Program Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.