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

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SINSINPAS COLD PATCH

Active Ingredients

L-Menthol (5%)

Purpose

Topical Analgesic

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.

Uses

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

Warnings

For external use only


Do not use

When using this product

Ask a doctor before use if you are prone to allergic reaction from aspirin or salicylates

Stop use and ask a doctor if

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

Directions

Adults and children 12 years of age and over:

Children undress 12 years of age: consult a doctor

Inactive Ingredients

Aloe vera gel, BHT, Castor oil, concentrated glycerin, disodium edetate hydrate, dried aluminum hydoxide gel, gelatin, isopropyl myristate, kaolin, magnesium aluminometasilicate, methyl paraben, PEG monostearte, polysorbate 80, polyvinyl alcohol, purified water, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, tocopherol acetate.

SINSINPAS COLD PATCH

SINSINPAS COLD PATCH LABEL

SINSINPAS COLD 
l-menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55264-104
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.85 g  in 17 g
Inactive Ingredients
Ingredient NameStrength
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
POVIDONE (UNII: FZ989GH94E)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
GELATIN (UNII: 2G86QN327L)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
SILODRATE (UNII: 9T3UU8T0QK)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
CASTOR OIL (UNII: D5340Y2I9G)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
KAOLIN (UNII: 24H4NWX5CO)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55264-104-024 in 1 POUCH08/01/2018
1NDC:55264-104-0117 g in 1 PATCH; Type 0: Not a Combination Product
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01708/01/2018
Labeler - Sinsin Pharmaceutical Co., Ltd. (823149161)
Registrant - Sinsin Pharmaceutical Co., Ltd. (687867143)
Establishment
NameAddressID/FEIBusiness Operations
Sinsin Pharmaceutical Co., Ltd.687867143manufacture(55264-104)

Revised: 1/2024
Document Id: 0e3cb18b-0257-3807-e063-6394a90a3793
Set id: 730e54c9-7dbc-4c0a-919c-3e8cb625e144
Version: 19
Effective Time: 20240105
 
Sinsin Pharmaceutical Co., Ltd.