Otc - Active Ingredient
Active ingredient
Capsicum extract 0.04% (Containing Capsaicin 0.025%)
Satogesic Hot Patch
FDA Label NDC 49873-608
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 Satogesic Hot (NDC 49873-608). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose
Capsaicin External analgesic
Indications & 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
Otc - Do Not Use
Do not use
■ on wounds, or on damaged, or irritated skin
■ on children under 12 years with arthritis-like conditions unless directed by a doctor
Otc - When Using
When using this product
■ avoid contact with eyes or mucous membranes ■ do not cover with any additional wrap
Otc - Stop Use
Stop use and ask a doctor if
■ rash, itching or excessive irritation develops ■ redness occurs ■ condition worsens
■ symptoms persist for more than 7 days ■ symptoms clear up and occur again withn a few days
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions■ Adults and children 2 years of age and over: ■ strip off the polyethylene film and place adhesive pad over affected area ■ pad may be cut with scissors for small areas such as fingers ■ change pad 1 or 2 times a day ■ apply to affected area not more than 3 or 4 times daily■ Children under 2 years of age: do not use, consult a doctor
Other Safety Information
Other information
■ store unused pads in the pouch ■ reseal the pouch after opening and keep tightly closed
Inactive Ingredient
Inactive ingredients
Butylparaben, carbomer, carboxymethylcellulose sodium, dried aluminum hydroxide gel, edetate disodium, glycerin, malic acid, methacrylic acid and n-butyl acrylate copolymer, methylparaben, partially neutralized polyacrylate, polyethylene glycol 3000 hydrogenated castor oil, polyvinyl alcohol, purified water, sorbitol, titanium dioxide
Package Label.Principal Display Panel
SatogesicHotGelPadscartA.jpg 
Carton, Part A (Satogesichotgelpadscarta)
Carton, Part B (Satogesichotgelpadscartb)
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