Satogesic by Sato Pharmaceutical Co., Ltd. Satogesic Spray; De-list

Satogesic by

Drug Labeling and Warnings

Satogesic by is a Otc medication manufactured, distributed, or labeled by Sato Pharmaceutical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SATOGESIC- dl-camphor, l-menthol, methyl salicylate spray 
Sato Pharmaceutical Co., Ltd.

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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Satogesic Spray; De-list

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

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

For external use only.

Extremely flammable.  Keep away from fire or flame.

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 weere applied.  Read and follow all directions and warnings on this label.

Warning-contents under pressure

  • do not puncture or incinerate container
  • do not expose to heat or store at temperatures above 120 degrees F.

Keep out of reach of children to avoid accidental poisoning.  If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • adults and children 3 years of age and over:  Hold can upright and spray until wet.  Apply to affected area not more than 3 to 4 times daily.
  • children under 3 years of age:  Do not use and ask a doctor.

Inactive ingredients

alcohol, fragrance, liquefied petroleum gas, phenylethyl alcohol, propylene glycol

Carton

SATOGESIC 
dl-camphor, l-menthol, methyl salicylate spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 49873-067
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)5 g  in 100 mL
LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL4 g  in 100 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE10 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
LIQUEFIED PETROLEUM GAS (UNII: 5K616HU99V)  
PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 49873-067-01100 mL in 1 CAN; Type 0: Not a Combination Product11/25/199101/01/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/25/199101/01/2016
Labeler - Sato Pharmaceutical Co., Ltd. (690575642)
Establishment
NameAddressID/FEIBusiness Operations
Sato Pharmaceutical Co., Ltd.715699133manufacture(49873-067)

Revised: 4/2020
 
Sato Pharmaceutical Co., Ltd.