Satogesic Hot

Dosage form: patch
Ingredients: CAPSAICIN 0.25mg
Labeler: Sato Pharmaceutical Co., Ltd.
NDC Code: 49873-608

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 ingredient    
Capsicum extract 0.04% (Containing Capsaicin 0.025%)

Purpose
Capsaicin    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, or irritated skin
■ on children under 12 years with arthritis-like conditions unless directed by a doctor

When using this product
■ avoid contact with eyes or mucous membranes  ■ do not cover with any additional wrap

Stop use and ask a doctor if
■ rash, itching or excessive irritation develops  ■ redness occurs  ■ 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
■ Adults and children 2 years of age and over:
    ■ strip off the polyethylene film and place adhesive pad over affected area
    ■ pad may be cut with scissors for small areas such as fingers
    ■ change pad 1 or 2 times a day
    ■ apply to affected area not more than 3 or 4 times daily
■ Children under 2 years of age: do not use, consult a doctor

Other information
■ store unused pads in the pouch  ■ reseal the pouch after opening and keep tightly closed

Inactive ingredients
Butylparaben, carbomer, carboxymethylcellulose sodium, dried aluminum hydroxide gel, edetate disodium, glycerin, malic acid, methacrylic acid and n-butyl acrylate copolymer, methylparaben, partially neutralized polyacrylate, polyethylene glycol 3000 hydrogenated castor oil, polyvinyl alcohol, purified water, sorbitol, titanium dioxide

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SATOGESIC HOT 
capsaicin patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49873-608
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (CAPSAICIN) CAPSAICIN0.25 mg
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE SODIUM 
POLYVINYL ALCOHOL 
SORBITOL 
GLYCERIN 
TITANIUM DIOXIDE 
EDETATE DISODIUM 
ALGELDRATE 
MALIC ACID 
WATER 
BUTYLPARABEN 
METHYLPARABEN 
POLYOXYL 60 HYDROGENATED CASTOR OIL 
Packaging
#Item CodePackage Description
1NDC:49873-608-011 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 not finalpart34811/22/2006
Labeler - Sato Pharmaceutical Co., Ltd. (690575642)
Establishment
NameAddressID/FEIOperations
Sato Pharmaceutical Co., Ltd.715699133manufacture, label, pack

Revised: 05/2012
 
Sato Pharmaceutical Co., Ltd.

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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