Drug Labeling and Warnings

Drug Details [pdf]

SATOHAP PADS- dl-camphor, l-menthol, methyl salicylate patch 
Fuji Seal, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active ingredients
dl-Camphor 0.5%
l-Menthol 0.4%
Methyl Salicylate 0.8%

Purpose
dl-Camphor External analgesic
l-Menthol External analgesic
Methyl Salicylate External analgesic

Uses temporary relieves minor aches and pains of muscles and joints associated with
■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains

Warnings
For external use only

Do not use
■ on wounds or on damaged skin

When using this product
■ avoid contact with the eyes
■ do not bandage tightly

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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 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.

small pad

SM pad

lg pad

lg pad

SATOHAP PADS 
dl-camphor, l-menthol, methyl salicylate patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 71895-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)5 mg
LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL4 mg
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE8 mg
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
SORBITOL (UNII: 506T60A25R)  
GLYCERIN (UNII: PDC6A3C0OX)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ALGELDRATE (UNII: 03J11K103C)  
MALIC ACID (UNII: 817L1N4CKP)  
WATER (UNII: 059QF0KO0R)  
POLYOXYL 60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 71895-001-011 in 1 CARTON11/08/1989
15 in 1 POUCH; Type 0: Not a Combination Product
2NDC: 71895-001-021 in 1 CARTON11/08/1989
25 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/08/1989
Labeler - Fuji Seal, Inc. (718108843)
Establishment
NameAddressID/FEIBusiness Operations
Fuji Seal, Inc.718023935manufacture(71895-001)

Revised: 12/2017
 

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