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Medicated Pain by Sato Pharmaceutical Co., Ltd.

Dosage form: patch
Ingredients: CAMPHOR (SYNTHETIC) 5mg, LEVOMENTHOL 4mg, METHYL SALICYLATE 8mg
Labeler: Sato Pharmaceutical Co., Ltd.
NDC Code: 49873-606

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 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.

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MEDICATED PAIN 
dl-camphor, l-menthol, methyl salicylate patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49873-606
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 (METHYL SALICYLATE) METHYL SALICYLATE8 mg
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE SODIUM 
POLYVINYL ALCOHOL 
SORBITOL 
GLYCERIN 
TITANIUM DIOXIDE 
EDETATE DISODIUM 
ALGELDRATE 
MALIC ACID 
WATER 
POLYOXYL 60 HYDROGENATED CASTOR OIL 
Packaging
#Item CodePackage Description
1NDC:49873-606-011 POUCH (POUCH) in 1 CARTON
15 PATCH (PATCH) in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH DRUG PRODUCT MANUFACTURED EXCLUSIVELY FOR PRIVATE LABEL DISTRIBUTOR11/02/2001
Labeler - Sato Pharmaceutical Co., Ltd. (690575642)
Establishment
NameAddressID/FEIOperations
Sato Pharmaceutical Co., Ltd.715699133manufacture, label, pack

Revised: 05/2012
 
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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