PRIMA FLEUR HAND SANITIZER- ethyl alcohol gel 
Prima Fleur Botanicals, Inc.

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Prima Fleur Botanicals Hand Sanitizer

Directions for use

Directions for use

Warnings

warnings

Inactive Ingredients

Inactive Ingredients

Warnings

Warnings

Use

Use

Active Ingredients

Active Ingredients

Use

Use:

Prima Fleur Hand Sanitizer Gal front

gallon front label

Prima Fleur Hand Sanitizer 16oz front

16oz front

Prima Fleur Hand Sanitizer 8oz front

8 oz front label

Prima Fleur Hand Sanitizer 2oz front

2oz front label

PRIMA FLEUR HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71824-1702
Route of AdministrationCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL41.40297 mL  in 59.15 mL
Inactive Ingredients
Ingredient NameStrength
HYDROXYPROPYL GUAR (2500-4500 MPA.S AT 1%) (UNII: 3A1I7376TC)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71824-1702-11 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/11/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph Drug505G(a)(3)08/11/2020
PRIMA FLEUR HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71824-1708
Route of AdministrationCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL165.6116 mL  in 236.588 mL
Inactive Ingredients
Ingredient NameStrength
HYDROXYPROPYL GUAR (2500-4500 MPA.S AT 1%) (UNII: 3A1I7376TC)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71824-1708-11 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/11/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph Drug505G(a)(3)08/11/2020
PRIMA FLEUR HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71824-1716
Route of AdministrationCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL331.2232 mL  in 473.176 mL
Inactive Ingredients
Ingredient NameStrength
HYDROXYPROPYL GUAR (2500-4500 MPA.S AT 1%) (UNII: 3A1I7376TC)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71824-1716-11 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/11/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph Drug505G(a)(3)08/11/2020
PRIMA FLEUR HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71824-1700
Route of AdministrationCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL2649.787 mL  in 3785.41 mL
Inactive Ingredients
Ingredient NameStrength
HYDROXYPROPYL GUAR (2500-4500 MPA.S AT 1%) (UNII: 3A1I7376TC)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71824-1700-11 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/11/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph Drug505G(a)(3)08/11/2020
Labeler - Prima Fleur Botanicals, Inc. (825058308)
Registrant - Prima Fleur Botanicals, Inc. (825058308)
Establishment
NameAddressID/FEIBusiness Operations
Prima Fleur Botanicals, Inc.825058308manufacture(71824-1700, 71824-1702, 71824-1708, 71824-1716)

Revised: 2/2024
Document Id: 10570edd-49ad-857a-e063-6294a90aa09b
Set id: aca372a3-9b44-5816-e053-2995a90a2d6b
Version: 3
Effective Time: 20240201
 
Prima Fleur Botanicals, Inc.