Skip to Content

← See all Satohap brands

Satohap by Sato Pharmaceutical Co., Ltd.

Dosage form: spray
Ingredients: METHYL SALICYLATE 10g in 100mL, CAMPHOR (SYNTHETIC) 5g in 100mL, LEVOMENTHOL 4g in 100mL
Labeler: Sato Pharmaceutical Co., Ltd.
NDC Code: 49873-068

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

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

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

SATOHAP 
methyl salicylate, dl-camphor, l-menthol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49873-068
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE10 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
ALCOHOL 
LIQUEFIED PETROLEUM GAS 
PHENYLETHYL ALCOHOL 
PROPYLENE GLYCOL 
Packaging
#Item CodePackage Description
1NDC:49873-068-0270 mL in 1 CANISTER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/09/2006
Labeler - Sato Pharmaceutical Co., Ltd. (690575642)
Establishment
NameAddressID/FEIOperations
Sato Pharmaceutical Co., Ltd.715699133manufacture(49873-068)

 
Sato Pharmaceutical Co., Ltd.

← See all Satohap brands

Medically reviewed on Apr 17, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide