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

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Prima Fleur Hand Sanitizer Bergamot Neroli

Directions for Use

Directions for Use

Warnings

Warnings

Inactive Ingredients

Inactive Ingredients

Directions for Use

Directions for Use2

Warnings

Warnings2

Use

Use

Active Ingredient

Active Ingredient

Prima Fleur Hand Sanitizer Bergamot Neroli gallon front label

gallon front label

Prima Fleur Hand Sanitizer Bergamot Neroli 16oz front label

16oz front label

Prima Fleur Hand Sanitizer Bergamot Neroli 8oz front label

8oz front label

Prima Fleur Hand Sanitizer Bergamot Neroli 2oz front label

2oz front label

PRIMA FLEUR HAND SANITIZER BERGAMOTI NEROLI 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71824-1800
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
HYDROXYPROPYL GUAR (2500-4500 MPA.S AT 1%) (UNII: 3A1I7376TC)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
GLYCERIN (UNII: PDC6A3C0OX)  
CITRUS AURANTIUM FLOWER OIL (UNII: D4BGE91OXH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71824-1800-11 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/14/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph Drug505G(a)(3)08/14/2020
PRIMA FLEUR HAND SANITIZER BERGAMOTI NEROLI 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71824-1816
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
HYDROXYPROPYL GUAR (2500-4500 MPA.S AT 1%) (UNII: 3A1I7376TC)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERIN (UNII: PDC6A3C0OX)  
CITRUS AURANTIUM FLOWER OIL (UNII: D4BGE91OXH)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71824-1816-11 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/14/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph Drug505G(a)(3)08/14/2020
PRIMA FLEUR HAND SANITIZER BERGAMOTI NEROLI 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71824-1802
Route of AdministrationCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL41.40297 mL  in 59.51 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
HYDROXYPROPYL GUAR (2500-4500 MPA.S AT 1%) (UNII: 3A1I7376TC)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERIN (UNII: PDC6A3C0OX)  
CITRUS AURANTIUM FLOWER OIL (UNII: D4BGE91OXH)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71824-1802-11 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product08/14/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph Drug505G(a)(3)08/14/2020
PRIMA FLEUR HAND SANITIZER BERGAMOTI NEROLI 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71824-1808
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
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
HYDROXYPROPYL GUAR (2500-4500 MPA.S AT 1%) (UNII: 3A1I7376TC)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERIN (UNII: PDC6A3C0OX)  
CITRUS AURANTIUM FLOWER OIL (UNII: D4BGE91OXH)  
BERGAMOT OIL (UNII: 39W1PKE3JI)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71824-1808-11 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/14/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph Drug505G(a)(3)08/14/2020
Labeler - Prima Fleur Botanicals, Inc. (825058308)
Registrant - Prima Fleur Botanicals, Inc. (825058308)
Establishment
NameAddressID/FEIBusiness Operations
Prima Fleur Botanicals, Inc.825058308manufacture(71824-1800, 71824-1816, 71824-1808, 71824-1802)

Revised: 1/2024
Document Id: 1047f882-e135-43ca-e063-6294a90ae42f
Set id: acde9963-c47f-3051-e053-2a95a90a6fd2
Version: 3
Effective Time: 20240131
 
Prima Fleur Botanicals, Inc.