Otc - Active Ingredient
Active ingredients
dl-Camphor 0.5%
l-Menthol 0.4%
Methyl Salicylate 0.8%
Satohap Patch
FDA Label NDC 49873-018
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 (NDC 49873-018). 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
dl-Camphor External analgesic
l-Menthol External analgesic
Methyl Salicylate 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 skin
Otc - When Using
When using this product
■ avoid contact with the eyes
■ do not bandage tightly
Otc - Stop Use
Stop use and ask a doctor if
■ 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
■ Strip off the polyethylene film and place adhesive pad over affected area.
■ Change pad 1 or 2 times a day
■ Not for children under 4 years.
Inactive Ingredient
Inactive ingredients
aluminum hydroxide gel, carbomer, carmellose sodium, edetate disodium, glycerin, malic acid, methacrylic acid and n-butyl acrylate copolymer, partially hydrolyzed polyvinyl alcohol, partially neutralized polyacrylate, PEG 60 hydrogenated castor oil, sorbitol, titanium dioxide, water.
Package Label.Principal Display Panel
Satohapsmcart.jpg
SatohapsmPDP.jpg
satohaplgcart.jpg 
SatohapsmPDP.jpg
satohaplgcart.jpg
-02 Carton (Satohaplgcart)
* Please review the disclaimer below.
