dl-camphor, l-menthol, methyl salicylate

FDA Drug Profile — Satohap, Satogesic

Drug Details

Generic Name
dl-camphor, l-menthol, methyl salicylate
Brand Names
Satohap, Satogesic
Application Number
M017
Sponsor
Sato Pharmaceutical Co., Ltd.
NDC Codes
2
Dosage Forms
PATCH
Routes
TOPICAL
Active Ingredients
CAMPHOR (SYNTHETIC), LEVOMENTHOL, METHYL SALICYLATE

Indications and Usage

Uses temporary relieves minor aches and pains of muscles and joints associated with ■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains

Warnings

Warnings For external use only Do not use ■ on irritated, broken, or damaged skin ■ on wounds ■ otherwise than as directed When using this product ■ avoid contact with the eyes or mucous membranes ■ do not bandage the area tightly and do not apply local heat (heating pads, lamps, hot water in bags or bottles) because doing so can increase 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 ■ when using for pain of arthritis: ■ pain persists for more than 10 days ■ redness is present ■ in conditions affecting children under 12 years of age ■ you experience pain, swelling, or blistering of the skin (this product should not cause pain or skin damage) Warning - Rare cases of serious burns have been reported to occur on the skin where OTC external analgesics were applied. Read and follow all directions and warnings on this label. Keep out of reach of children to avoid accidental poisoning. If swallowed, get medical help or contact a Poison Control Center right away.