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.

SATOHAP PADS 
dl-camphor, l-menthol, methyl salicylate patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71895-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET)	CAMPHOR (SYNTHETIC)	5 mg
LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7)	LEVOMENTHOL	4 mg
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	8 mg

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71895-001-01	1 in 1 CARTON	11/08/1989
1		5 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 71895-001-02	1 in 1 CARTON	11/08/1989
2		5 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/08/1989

Labeler - Fuji Seal, Inc. (718108843)

Establishment
Name	Address	ID/FEI	Business Operations
Fuji Seal, Inc.		718023935	manufacture(71895-001)

Revised: 12/2017

Document Id: bbc031c0-8a40-4ebe-87aa-94c45fd4e260

34390-5

Set id: cd06eae5-0e48-4776-b80d-68a61ebd11d4

Version: 2

Effective Time: 20171231