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Satohap by Sato Pharmaceutical Co., Ltd.

Dosage form: lotion
Ingredients: METHYL SALICYLATE 10g in 100mL, CAMPHOR (SYNTHETIC) 5g in 100mL, LEVOMENTHOL 4g in 100mL
Labeler: Sato Pharmaceutical Co., Ltd.
NDC Code: 49873-065

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 5%
l-Menthol 4%
Methyl salicylate 10%

Purpose
dl-Camphor    External analgesic
l-Menthol    External analgesic
Methyl salicylate    External analgesic

Uses

temporarily relieves minor aches and pains of muscles and joints due to
■ backache     ■ arthritis     ■ strains     ■ bruises     ■ sprains

Warnings
For external use only

Do not use
■ on wounds
■ on damaged or irritated skin

When using this product
■ avoid contact with the eyes and mucous membranes
■ do not bandage tightly

Stop use and ask a doctor if
■ excessive irritation develops
■ condition worsens
■ symptoms persist for more than 7 days
■ symptoms clear up and occur again within a few days
■ when using for pain of arthritis if:
    ■ pain persist for more than 10 days
    ■ redness is present
    ■ in conditions affecting children under 12 years of age

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: apply to affected area not more than 3 to 4 times daily.
■ children under 2 years of age: do not use, ask a doctor.

Inactive ingredients
edetate disodium, alcohol, propylene glycol, water

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SATOHAP 
methyl salicylate, dl-camphor, l-menthol lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49873-065
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (salicylic acid) salicylic acid10 g  in 100 mL
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC)5 g  in 100 mL
LEVOMENTHOL (LEVOMENTHOL) LEVOMENTHOL4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
EDETATE DISODIUM 
ALCOHOL 
PROPYLENE GLYCOL 
WATER 
Packaging
#Item CodePackage Description
1NDC:49873-065-011 BOTTLE, WITH APPLICATOR (BOTTLE) in 1 CARTON
145 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/05/1991
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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