MEGACLEAN HAND SANITIZER- ethanol gel 
MEGACITY GROUP LLC

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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MegaClean HAND SANITIZER 1 Gallon Gel type
77799-001-01

1 Gallon Gel Type

MEGACLEAN HAND SANITIZER 
ethanol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77799-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL2646 mL  in 3780 mL
Inactive Ingredients
Ingredient NameStrength
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TROLAMINE (UNII: 9O3K93S3TK)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77799-001-013780 mL in 1 BOTTLE; Type 0: Not a Combination Product05/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/31/2020
Labeler - MEGACITY GROUP LLC (094579228)
Establishment
NameAddressID/FEIBusiness Operations
BL Cosmetic Co., Ltd695735124manufacture(77799-001)

Revised: 5/2020
Document Id: a6f97c38-2f81-c63d-e053-2995a90ae39f
Set id: a6f96f14-99ab-23d7-e053-2a95a90aedd1
Version: 1
Effective Time: 20200531
 
MEGACITY GROUP LLC