Active Ingredients
Camphor 3.1%
Capsaicin 0.025%
Menthol 6%
Satohap Cool And Hot Pads Patch
FDA Label NDC 49873-621
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sato Pharmaceutical Co., Ltd. for the product Satohap Cool And Hot Pads (NDC 49873-621). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, do not use, ask a doctor or pharmacist before use if you have, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 persists for more than 7 days
- symptoms clear up and occur again within a few days
- excessive irritation of the skin developes
- nausea, vomiting, abdominal discomfort, diarrhea, or skin rash occurs.
- you feel actual pain or experience a blistering or burning after application (it is normal to feel awarming 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
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.
Questions Or Comments?
- contact Sato Pharmaceutical Inc. 20695 S. Western Ave., Suite 240, Torrence, CA 90501
- you may also report serious side effects to this address
* Please review the disclaimer below.
