SATOHAP COOL TYPE- camphor, menthol, methyl salicylate lotion 
Sato Pharmaceutical Co., Ltd.

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Satohap Lotion (Cool Type)

Active ingredients

Camphor

Menthol

Methyl salicylate

Purpose

Camphor   External analgesic

Menthol   External analgesic

Methyl salicylate   External analgesic

Uses  Temporarily relieves minor aches and pains of muscles and joints due to:

Warnings

For external use only

Flammable: Keep away from fire or flame

Do not use

  • on wounds
  • on irritated, broken, or damaged skin
  • otherwise than as directed

When using this product

  • avoid contact with the eyes or mucous membranes
  • do not bandage 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 were applied.  Read and follow all directions and warnings on this label.

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

Directions

Other information

Inactive ingredients

alcohol, propylene glycol, water.

Carton

SATOHAP COOL TYPE 
camphor, menthol, methyl salicylate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49873-620
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) LEVOMENTHOL6 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)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49873-620-011 in 1 CARTON01/10/2019
145 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01701/10/2019
Labeler - Sato Pharmaceutical Co., Ltd. (690575642)
Establishment
NameAddressID/FEIBusiness Operations
Sato Pharmaceutical Co., Ltd.715699133manufacture(49873-620) , pack(49873-620) , label(49873-620)

Revised: 11/2023
Document Id: 09956557-edf5-48db-e063-6294a90a7dc8
Set id: fe07a00a-2699-44d3-887d-bd068948ad7b
Version: 4
Effective Time: 20231107
 
Sato Pharmaceutical Co., Ltd.