INTOSKIN ANTISEPTIC HAND SANITIZER GEL- ethyl alcohol gel 
Beauty Signal 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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INTOSKIN ANTISEPTIC HAND SANITIZER GEL 60 ML (PET) : 76654-062-01

60pet

INTOSKIN ANTISEPTIC HAND SANITIZER GEL 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76654-062
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL37.2 mL  in 60 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PANTHENOL (UNII: WV9CM0O67Z)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76654-062-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product04/24/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A04/24/2020
Labeler - Beauty Signal Co., Ltd. (694206316)
Establishment
NameAddressID/FEIBusiness Operations
KOREA COSPACK CO.,LTD.689059789manufacture(76654-062)

Revised: 4/2020
Document Id: a412a119-da89-f317-e053-2995a90aba09
Set id: a412a119-da88-f317-e053-2995a90aba09
Version: 1
Effective Time: 20200424
 
Beauty Signal Co., Ltd.