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Satogesic by Sato Pharmaceutical Co., Ltd.

Dosage form: patch
Ingredients: CAMPHOR (SYNTHETIC) 5mg, LEVOMENTHOL 4mg, METHYL SALICYLATE 8mg
Labeler: Sato Pharmaceutical Co., Ltd.
NDC Code: 49873-060

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.

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:49873-060
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC)5 mg
LEVOMENTHOL (LEVOMENTHOL) LEVOMENTHOL4 mg
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE8 mg
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE SODIUM 
POLYVINYL ALCOHOL 
SORBITOL 
GLYCERIN 
TITANIUM DIOXIDE 
EDETATE DISODIUM 
MALIC ACID 
WATER 
POLYOXYL 60 HYDROGENATED CASTOR OIL 
ALGELDRATE 
ACRYLIC ACID/SODIUM ACRYLATE COPOLYMER (1:1; 600 MPA.S AT 0.2%) 
CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) 
Packaging
#Item CodePackage Description
1NDC:49873-060-011 POUCH in 1 CARTON
15 PATCH in 1 POUCH
2NDC:49873-060-021 POUCH in 1 CARTON
25 PATCH in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/03/1990
Labeler - Sato Pharmaceutical Co., Ltd. (690575642)
Establishment
NameAddressID/FEIOperations
Sato Pharmaceutical Co., Ltd.715699133manufacture(49873-060), label(49873-060), pack(49873-060)
Establishment
NameAddressID/FEIOperations
Fuji Seal, Inc.694851010pack(49873-060), label(49873-060)

Revised: 09/2013
 
Sato Pharmaceutical Co., Ltd.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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