DRUG FACTS

Drug Labeling and Warnings

Drug Details [pdf]

SATOGESIC- 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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DRUG FACTS

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 irritated, broken, or damaged skin    ■ on wounds    ■ otherwise than as directed

When using this product
■ avoid contact with the eyes or mucous membranes ■ do not bandage the area

tightly and do not apply local heat (heating pads, lamps, hot water in bags or bottles)

because doing so can increase the risk of serious burns

Stop use and ask a doctor if
■ condition worsens   ■ symptoms persist for more than 7 days   ■ symptoms clear up

and occur again within a few days

■ excessive irritation of the skin develops   ■ nausea, vomiting,

abdominal discomfort, diarrhea, or skin rash occurs

■ when using for pain of arthritis:

     ■ pain persists for more than 10 days  ■ redness is present  ■ in conditions

        affecting children under 12 years of age

■ you experience pain, swelling, or blistering of the skin (this product should not cause

   pain or skin damage)

Warning - Rare cases of serious burns have been reported to occur on the skin where

OTC external analgesics were applied. Read and follow all directions and warnings on

this label.

Keep out of reach of children to avoid accidental poisoning.  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.

Other Information
■ keep pouch tightly closed until ready to use   ■ store at room temperature (20° to 25°C or 68° to 77°F)

Inactive ingredients
carbomer 940, carboxymethylcellulose sodium, dried aluminum hydroxide gel, 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.

SATOGESIC 
dl-camphor, l-menthol, methyl salicylate patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71895-002
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 (UNII: 532B59J990)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
MALIC ACID (UNII: 817L1N4CKP)
WATER (UNII: 059QF0KO0R)
POLYOXYL 60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)
ALGELDRATE (UNII: 03J11K103C)
ACRYLIC ACID/SODIUM ACRYLATE COPOLYMER (1:1; 600 MPA.S AT 0.2%) (UNII: M4PPW69Y4H)
CARBOMER 940 (UNII: 4Q93RCW27E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71895-002-01	1 in 1 CARTON	12/03/1990
1		5 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 71895-002-02	1 in 1 CARTON	12/03/1990
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	12/03/1990

Labeler - Fuji Seal, Inc. (718108843)

Establishment
Name	Address	ID/FEI	Business Operations
Fuji Seal, Inc.		718023935	manufacture(71895-002)

Revised: 12/2017

Document Id: e5e2a5f8-7cb2-4b49-8f5e-7658780dde5e

34390-5

Set id: 83d572a1-7189-429f-ae13-3c9aa9cd6bd9

Version: 2

Effective Time: 20171231