SATOHAP COOL AND HOT PADS- camphor, capsaicin, menthol patch 
Sato Pharmaceutical Co., Ltd.

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Satohap Cool & Hot Pads - 5 pads in 1 pouch - (13cm by 8cm each pad)

Active ingredients

Camphor 3.1%

Capsaicin 0.025%

Menthol 6%

Purpose

External analgesic

External analgesic

External analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints due to:

Warnings

For external use only

Do not use

  • on irritated or damaged skin
  • on wounds

Ask a doctor or pharmacist before use if you have

  • any concerns about using this product

When using this product

  • avoid contact with the eyes or mucus membranes
  • do not bandage tightly
  • do not apply heat to the area in the form of heating pads, hot water bottles, or lamps (doing so increases 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.
  • you feel actual pain or experience blistering or burning after application (it is normal to feel a warming or cooling sensation)
  • when using for pain or arthritis:
  • pain persists for more than 10 days
  • redness is present
  • in conditions affecting children under 12 years of age

Report any unexpected side effects from the use of this product to the FDA MedWatch Program

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

carboxymethylcellulose sodium, dihydroxyaluminum aminoacetate, dried aluminum hydroxide gel, edetate disodium, emulsion of methyl acrylate and 2-ethylhexyl acrylate copolymer, glycerin, malic acid, partially neutralized polyacrylate, polysorbate 80, polyvinyl alcohol, sorbitol solution, talc, titanium dioxide, and water on a polyester fiber backing and covered with a polyethylene film.

Questions or comments?

Satohap Cool and Hot Pads

Satohap Cool and Hot Pads

SATOHAP COOL AND HOT PADS 
camphor, capsaicin, menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49873-621
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)3.1 g  in 100 g
LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL6 g  in 100 g
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.025 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ACRYLIC ACID/SODIUM ACRYLATE COPOLYMER (1:1; 600 MPA.S AT 0.2%) (UNII: M4PPW69Y4H)  
2-ETHYLHEXYL ACRYLATE (UNII: HR49R9S6XG)  
METHYL ACRYLATE (UNII: WC487PR91H)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
WATER (UNII: 059QF0KO0R)  
MALIC ACID (UNII: 817L1N4CKP)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
GLYCERIN (UNII: PDC6A3C0OX)  
TALC (UNII: 7SEV7J4R1U)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49873-621-011 in 1 BOX12/18/2020
15 in 1 POUCH
19.36 g in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01712/18/2020
Labeler - Sato Pharmaceutical Co., Ltd. (690575642)
Establishment
NameAddressID/FEIBusiness Operations
Sato Pharmaceutical Co., Ltd.715699133label(49873-621) , manufacture(49873-621) , pack(49873-621)
Establishment
NameAddressID/FEIBusiness Operations
Fuji Seal, Inc.718023935label(49873-621) , pack(49873-621)

Revised: 9/2024
Document Id: 21ad4b4b-1f8b-9b58-e063-6394a90a3a61
Set id: b6bf1eab-4ab9-f500-e053-2995a90a8d7b
Version: 4
Effective Time: 20240901
 
Sato Pharmaceutical Co., Ltd.