BIOMIRACLE STAYSAFE HAND SANITIZER- alcohol gel 
MJM SOURCING, 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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[Manufacturer:WHITE COSPHARM CO.,LTD.]
[Labeler : MJM SOURCING, LLC]
77978-108-01
BioMiracle staysafe HAND SANITIZER

1 GALLON

BIOMIRACLE STAYSAFE HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77978-108
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL2649 mL  in 3785 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
TROLAMINE (UNII: 9O3K93S3TK)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GRAPEFRUIT (UNII: O82C39RR8C)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77978-108-013785 mL in 1 BOTTLE; Type 0: Not a Combination Product07/13/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/13/2020
Labeler - MJM SOURCING, LLC (078861054)
Establishment
NameAddressID/FEIBusiness Operations
WHITE COSPHARM CO.,LTD.688442259manufacture(77978-108)

Revised: 7/2020
Document Id: aa5fa6bc-87bc-4e8c-e053-2a95a90a7ded
Set id: aa5fab87-19e1-5031-e053-2995a90a06df
Version: 1
Effective Time: 20200713
 
MJM SOURCING, LLC