Fuji Seal, Inc. DRUG FACTS

Drug Labeling and Warnings

Drug Details [pdf]

SATOGESIC HOT- capsaicin patch 
Fuji Seal, Inc.

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.

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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.

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

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

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

SATOGESIC HOT 
capsaicin patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71895-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.25 mg

Inactive Ingredients
Ingredient Name	Strength
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 132584PQMO)
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)
ACRYLIC ACID/SODIUM ACRYLATE COPOLYMER (1:1; 600 MPA.S AT 0.2%) (UNII: M4PPW69Y4H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71895-003-01	1 in 1 CARTON	11/22/2006
1		5 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/22/2006

Labeler - Fuji Seal, Inc. (718108843)

Establishment
Name	Address	ID/FEI	Business Operations
Fuji Seal, Inc.		718023935	manufacture(71895-003)

Revised: 12/2017

Document Id: e05b38ff-0640-4cbd-b214-f99da8692dc8

34390-5

Set id: 66f14f27-ed04-4560-a44a-b31b69fae618

Version: 2

Effective Time: 20171231

 

Fuji Seal, Inc.