UNSCENTED HAND SANITIZER GEL- alcohol gel 
HAND SANITIZER GEL WITH DRAGONS BREATH- alcohol gel 
HAND SANITIZER GEL WITH LAVENDER- alcohol gel 
NATURE'S FUSIONS, 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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Hand Sanitizer Gel

Gel with dragon's breath Dragon's Breath Gel

Unscented Clear Gel

Lavender gel Lavender gel

UNSCENTED HAND SANITIZER GEL 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73769-050
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL69.8 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73769-050-0259 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
HAND SANITIZER GEL WITH DRAGONS BREATH 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73769-051
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL69.8 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
CINNAMON BARK OIL (UNII: XE54U569EC)  
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
GLYCERIN (UNII: PDC6A3C0OX)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
EUCALYPTUS RADIATA LEAF OIL (UNII: SB9A7612BD)  
OREGANO LEAF OIL (UNII: 7D0CGR40U1)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
LEMON OIL (UNII: I9GRO824LL)  
CLOVE OIL (UNII: 578389D6D0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73769-051-0259 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
HAND SANITIZER GEL WITH LAVENDER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73769-054
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL69.8 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
GLYCERIN (UNII: PDC6A3C0OX)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73769-054-0259 mL in 1 BOTTLE; Type 0: Not a Combination Product08/26/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/26/2020
Labeler - NATURE'S FUSIONS, LLC (051472644)
Establishment
NameAddressID/FEIBusiness Operations
NATURE'S FUSIONS, LLC051472644manufacture(73769-050, 73769-051, 73769-054)

Revised: 8/2020
Document Id: adcecb8c-ab05-fc92-e053-2a95a90a3f62
Set id: a1539d98-6907-550f-e053-2995a90a7909
Version: 2
Effective Time: 20200826
 
NATURE'S FUSIONS, LLC