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Satohap

Sato Pharmaceutical Co., Ltd.

Drug Facts




FULL PRESCRIBING INFORMATION

Active ingredient

Active ingredients
dl-Camphor 5%
l-Menthol 4%
Methyl salicylate 10%

Purpose

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

Uses

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

Satohap

Satohap

methyl salicylate, dl-camphor, l-menthol SPRAY

Product Information

Product Type Human otc drug label Item Code (Source) NDC:49873-068
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
methyl salicylate METHYL SALICYLATE 10 g
CAMPHOR (SYNTHETIC) 5 g
LEVOMENTHOL 4 g

Inactive Ingredients

Ingredient Name Strength
ALCOHOL
LIQUEFIED PETROLEUM GAS
PHENYLETHYL ALCOHOL
propylene glycol

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49873-068-02 70 in 1 CANISTER

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part348 2006-11-09


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Be sure to consult your doctor before taking any medication!
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