SINSINPAP COOL- levomenthol, thymol, camphor, mentha, eucalyptus patch 
Sinsin Pharmaceutical Co., Ltd.

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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SINSINPAP COOL

Active ingredients

L-Menthol 49.4 mg

Thymol 16.5 mg

DL-Camphor 82.4 mg

Mentha Oil 164.7 mg

Eucalyptus Oil 16.5 mg

Purpose

Topical Analgesic

Uses

Temporarily relieves minor pain associated with

Warnings

For external use only

When using this product:

Stop use and ask a doctor if

Keep out of reach of children.

If swallowed, get medical help from hospital right away

Directions

Storage condition

Inactive ingredients

BHT, Castor oil, Concentrated Glycerin, Disodium edetate hydrate, D-sorbitol, Isopropyl myristate, Kaolin, Magnesium aluminometasilicate, Methyl Paraben, PEG-4 stearate, Polysorbate 80, Titanium dioxide, Carboxymethylcellulose Sodium, Sodium Polyacrylate, Polyvinyl alchol, Gelatin, Tataric acid, Purified water

Manufactured by:

SINSIN PHARM. CO., LTD.

Distributed by SS Pharmed USA

Made in Korea

NDC # : 55264-012-01

Principal Display Panel

Sinsin Pap Cool

SINSINPAP COOL 
levomenthol, thymol, camphor, mentha, eucalyptus patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55264-012
Route of AdministrationTOPICAL, CUTANEOUS, TRANSDERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL49.4 mg
THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E) THYMOL16.5 mg
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)82.4 mg
PEPPERMINT OIL (UNII: AV092KU4JH) (PEPPERMINT - UNII:V95R5KMY2B) PEPPERMINT OIL164.7 mg
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL16.5 mg
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CASTOR OIL (UNII: D5340Y2I9G)  
GLYCERIN (UNII: PDC6A3C0OX)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SORBITOL (UNII: 506T60A25R)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
KAOLIN (UNII: 24H4NWX5CO)  
SILODRATE (UNII: 9T3UU8T0QK)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PEG-4 STEARATE (UNII: J33E8608YN)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
TARTARIC ACID (UNII: W4888I119H)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55264-012-051 in 1 CARTON05/30/2016
1NDC:55264-012-045 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/30/2016
Labeler - Sinsin Pharmaceutical Co., Ltd. (823149161)
Registrant - Sinsin Pharmaceutical Co., Ltd. (687867143)
Establishment
NameAddressID/FEIBusiness Operations
Sinsin Pharmaceutical Co., Ltd.687867143manufacture(55264-012)

Revised: 2/2023
Document Id: f5b822e0-794c-1f53-e053-2995a90a77d9
Set id: 9d47855f-ccb5-4557-a31a-a2b336fa9806
Version: 3
Effective Time: 20230227
 
Sinsin Pharmaceutical Co., Ltd.