SINSINPAS AREXGEL- l-menthol patch 
Sinsin Pharmaceutical Co., Ltd.

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SINSINPAS AREX GEL PATCH

Active Ingredients

L-Menthol 76.8mg

Methyl Salicylate 57.6mg

DL-Camphor 96.0mg

Purpose

Topical Analgesic

Uses

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

Warnings

For external use only


Do not use

Ask a doctor before use if you are allergic to any ingredients in this product.

When using this product

Stop use and ask a doctor if

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

Caution: This product contains natural rubber latex which may cause allergic reactions.

Keep out of reach of children

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Adults and children 12 years of age and over:

Children undress 12 years of age: consult a doctor

Other Information

Inactive Ingredients

Aloe vera gel, Butylated hydroxytoluene, Carboxymethylcellulose sodium, Castor oil, Concentrated glycerin, Disodium edetate hydrate, Dihydroxyalumium Aminoacetate, Gelatin, Kaolin, Methylparaben, Nonivamide, Polysorbate 80, Purified water, Sodium polyacrylate, Sorbitol, Tartaric acid, Titanium dioxide

SINSINPAS AREX GEL PATCH

SINSINPAS AREX GEL PATCH

SINSINPAS AREXGEL 
l-menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55264-114
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)96 mg
LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL76.8 mg
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE57.6 mg
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
NONIVAMIDE (UNII: S846B891OR)  
SORBITOL (UNII: 506T60A25R)  
GELATIN (UNII: 2G86QN327L)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
KAOLIN (UNII: 24H4NWX5CO)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CASTOR OIL (UNII: D5340Y2I9G)  
WATER (UNII: 059QF0KO0R)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55264-114-021 in 1 POUCH08/27/2021
1NDC:55264-114-016 in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01708/27/2021
Labeler - Sinsin Pharmaceutical Co., Ltd. (823149161)
Registrant - Sinsin Pharmaceutical Co., Ltd. (687867143)
Establishment
NameAddressID/FEIBusiness Operations
Sinsin Pharmaceutical Co., Ltd.687867143manufacture(55264-114)

Revised: 1/2024
Document Id: 0e3cb332-0192-23b2-e063-6294a90aed38
Set id: ca91bdca-0004-6617-e053-2a95a90ad7a0
Version: 3
Effective Time: 20240105
 
Sinsin Pharmaceutical Co., Ltd.