SINSINPAS AREX FLEX GEL PAIN RELIEVING PATCH- l-menthol patch 
Sinsin Pharmaceutical Co., Ltd.

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Active Ingredients

L-Menthol 76.8mg

Methyl Salicylate 57.6mg

DL-Camphor 96.0mg

Purpose

Topical Analgesic

For the temporary relief of minor aches and pains of muscles and joints associated with:

For external use only

Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.


Do not use

When using this product

Stop use and ask a doctor if

If pregnant or breast-feeding, ask a health professional before use.

Keep out or reach of children

Keep out of reach of children.

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

Directions

Adults and children 12 years of age and over:

■ clean and dry affected area
■ remove patch from film
■ apply to affected area not more than 3 times daily
■ remove patch from skin after at most 8 hours of application

children under 12 years of age: Consult a doctor

Other Information

■ avoid storing product in direct sunlight
■ protect product from excessive moisture

Inactive Ingredients

Butylated hydroxytoluene, Methylparaben, Polysorbate 80, Castor Oil, D-Sorbitol Solution,
Concentrated Glycerin, Dihydroxyaluminum, Aminoacetate, Disodium Edetate Hydrate, Carboxymethylcellulose sodium, Kaolin, Titanium Dioxide, Sodium Polyacrylate, Aloe Vera Gel, Gelatin, Nikasol TS-620, Tartaric Acid, Nonylic acid vanillyamide, Purified Water

Sinsinpas Arex Flex Gel Patch

SINSINPAS AREX FLEX GEL PAIN RELIEVING PATCH 
l-menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55264-116
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE57.6 mg
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)96 mg
LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL76.8 mg
Inactive Ingredients
Ingredient NameStrength
METHYLPARABEN (UNII: A2I8C7HI9T)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
TARTARIC ACID (UNII: W4888I119H)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
SORBITOL (UNII: 506T60A25R)  
GELATIN (UNII: 2G86QN327L)  
CASTOR OIL (UNII: D5340Y2I9G)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
NONIVAMIDE (UNII: S846B891OR)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
WATER (UNII: 059QF0KO0R)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
KAOLIN (UNII: 24H4NWX5CO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55264-116-021 in 1 POUCH05/01/2024
1NDC:55264-116-016 in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01705/01/2024
Labeler - Sinsin Pharmaceutical Co., Ltd. (823149161)
Registrant - Sinsin Pharmaceutical Co., Ltd. (687867143)
Establishment
NameAddressID/FEIBusiness Operations
Sinsin Pharmaceutical Co., Ltd.687867143manufacture(55264-116)

Revised: 5/2024
Document Id: 1758ef9b-4fad-4066-e063-6394a90a8cc3
Set id: 1758ef9b-4fac-4066-e063-6394a90a8cc3
Version: 1
Effective Time: 20240501
 
Sinsin Pharmaceutical Co., Ltd.