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.

----------

[Manufacturer: Honest Co., Ltd.] Labeler : MJM SOURCING, LLC
77978-501-01
BioMiracle staysafe HAND SANITIZER

500 mL

BIOMIRACLE STAYSAFE HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77978-501
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL350 mL  in 500 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:77978-501-01500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/27/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/27/2020
Labeler - MJM SOURCING, LLC (078861054)
Establishment
NameAddressID/FEIBusiness Operations
Honest Co., Ltd.694773213manufacture(77978-501)

Revised: 5/2020
Document Id: a6fa5ea9-5728-c4ff-e053-2995a90af4be
Set id: a6fa5e3e-4b65-4666-e053-2995a90a0aa2
Version: 1
Effective Time: 20200531
 
MJM SOURCING, LLC