FDA Label for Satohap Cool And Hot
View Indications, Usage & Precautions
Satohap Cool And Hot Product Label
The following document was submitted to the FDA by the labeler of this product Sato Pharmaceuticals Co., Ltd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredients
Camphor 3.1%
Capsaicin 0.025%
Menthol 6%
Purpose
External analgesic
External analgesic
External analgesic
Uses
For the temporary relief of minor aches and pains of muscles and joints due to:
- simple backache
- arthritis
- strains
- bruises
- sprains
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)
- pain persists for more than 10 days
- redness is present
- in conditions affecting children under 12 years of age
when using for pain of arthritis:
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Adults and children 4 years of age and older: remove polyethylene film and place adhesive pad over affected area.
- Do not use more than 2 patches per day.
- Children under 4 years of age: Consult a doctor.
Other Information
- keep pouch tightly closed
- keep product protected from heat
Inactive Ingredients
carboxymethylcellulose sodium, dihydroxyaluminum aminoacetate, dried aluminum hydroxide gel, edetate disodium, emulsion of methyl acrylate and 2-ethylhexyl acrylate copolymer, glycerin, malic acid, partially neutralized polyacrylate, polysorbate 80, polyvinyl alcohol, sorbitol solution, talc, titanium dioxide, and water on a polyester fiber backing and covered with a polyethylene film.
* Please review the disclaimer below.
