SATOGESIC HOT- capsaicin patch 
Sato Pharmaceutical Co., Ltd.

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DRUG FACTS

Active ingredient    
Capsicum extract 0.04% (Containing Capsaicin 0.025%)

Purpose
Capsaicin    External analgesic

Uses  temporary relieves minor aches and pains of muscles and joints associated with
■ simple backache    ■ arthritis    ■ strains    ■ bruises    ■ sprains

Warnings
For external use only

Do not use

■ on wounds, or on damaged, or irritated skin

■ on children under 12 years with arthritis-like conditions unless directed by a doctor


When using this product

■ avoid contact with eyes or mucous membranes ■ do not cover with any additional wrap

Stop use and ask a doctor if

■ rash, itching or excessive irritation develops ■ redness occurs ■ condition worsens

■ symptoms persist for more than 7 days ■ symptoms clear up and occur again withn a few days


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


Other information
■ store unused pads in the pouch  ■ reseal the pouch after opening and keep tightly closed

Directions

■ Adults and children 2 years of age and over:

■ strip off the polyethylene film and place adhesive pad over affected area

■ pad may be cut with scissors for small areas such as fingers

■ change pad 1 or 2 times a day

■ apply to affected area not more than 3 or 4 times daily

■ Children under 2 years of age: do not use, consult a doctor

Inactive ingredients
Butylparaben, carbomer, carboxymethylcellulose sodium, dried aluminum hydroxide gel, edetate disodium, glycerin, malic acid, methacrylic acid and n-butyl acrylate copolymer, methylparaben, partially neutralized polyacrylate, polyethylene glycol 3000 hydrogenated castor oil, polyvinyl alcohol, purified water, sorbitol, titanium dioxide

Carton, Part A




Carton, Part B


SATOGESIC HOT 
capsaicin patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49873-608
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.25 mg
Inactive Ingredients
Ingredient NameStrength
BUTYL ACRYLATE/METHACRYLIC ACID COPOLYMER (2% METHACRYLIC ACID) (UNII: Q984S31CYH)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
SORBITOL (UNII: 506T60A25R)  
GLYCERIN (UNII: PDC6A3C0OX)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ALGELDRATE (UNII: 03J11K103C)  
MALIC ACID (UNII: 817L1N4CKP)  
WATER (UNII: 059QF0KO0R)  
BUTYLPARABEN (UNII: 3QPI1U3FV8)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYOXYL 60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)  
CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 132584PQMO)  
ACRYLIC ACID/SODIUM ACRYLATE COPOLYMER (1:1; 600 MPA.S AT 0.2%) (UNII: M4PPW69Y4H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49873-608-011 in 1 CARTON05/17/2012
15 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01711/22/2006
Labeler - Sato Pharmaceutical Co., Ltd. (690575642)
Establishment
NameAddressID/FEIBusiness Operations
Sato Pharmaceutical Co., Ltd.715699133manufacture(49873-608) , label(49873-608) , pack(49873-608)

Revised: 11/2023
Document Id: 09d8a40d-02a1-c265-e063-6294a90a8a0b
Set id: 16b47cb5-ea5f-4514-9a89-141ee4cc60f8
Version: 5
Effective Time: 20231110
 
Sato Pharmaceutical Co., Ltd.