Satohap Cool Type
Satohap Cool Type is an FDA drug label for the active ingredient CAMPHOR, MENTHOL, METHYL SALICYLATE manufactured by Sato Pharmaceutical Co., Ltd. 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 20231107.
- Generic name
- CAMPHOR, MENTHOL, METHYL SALICYLATE
- Manufacturer
- Sato Pharmaceutical Co., Ltd.
- Product type
- HUMAN OTC DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 49873-620
- Application
- M017
- Label effective
- 20231107
Active ingredients
Indications & Usage
Uses Temporarily relieves minor aches and pains of muscles and joints due to: simple backache arthritis strains bruises sprains
Dosage & Administration
Directions adults and children 3 years of age and older: apply to the affected area not more than 3 to 4 times daily children under 3 years of age: consult your physician refer to the above warnings; use otherwise than as directed may be dangersous
Contraindications
Not available.
Warnings
Warnings For external use only Flammable : Keep away from fire or flame Do not use on wounds on irritated, broken, or damaged skin otherwise than as directed When using this product avoid contact with the eyes or mucous membranes do not bandage 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.
Adverse Reactions
Not available.