Prima Fleur Hand Sanitizer - Lemon & Thyme

Prima Fleur Hand Sanitizer Lemon Thyme by

Drug Labeling and Warnings

Prima Fleur Hand Sanitizer Lemon Thyme by is a Otc medication manufactured, distributed, or labeled by Prima Fleur Botanicals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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Prima Fleur Hand Sanitizer - Lemon & Thyme

Directions for Use

Use

Warnings

Warnings

Inactive Ingredients

Inactive Ingredients

Use

Use:

Active Ingredients

active ingredients

Warnings

Warnings:

Use

Use3

Prima Fleur Hand Sanitizer Lemon Thyme gal front label

gal front label

Prima Fleur Hand Sanitizer Lemon Thyme 16oz front label

16oz front label

Prima Fleur Hand Sanitizer Lemon Thyme 8oz front label

8oz front label

Prima Fleur Hand Sanitizer Lemon Thyme 2oz front label

2oz front label

PRIMA FLEUR HAND SANITIZER LEMON THYME 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 71824-1908
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
BACKHOUSIA CITRIODORA LEAF OIL (UNII: 2UQQ0PI06P)  
LEPTOSPERMUM PETERSONII LEAF OIL (UNII: N37UWG52T3)  
HYDROXYPROPYL GUAR (2500-4500 MPA.S AT 1%) (UNII: 3A1I7376TC)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
LITSEA CUBEBA FRUIT (UNII: R3617MQA5Z)  
THYMUS VULGARIS LEAF (UNII: GRX3499643)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T)  
GLYCERIN (UNII: PDC6A3C0OX)  
LEMON OIL, DISTILLED (UNII: ET5GD00TRP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 71824-1908-11 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/13/202003/01/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph Drug505G(a)(3)08/13/202003/01/2024
PRIMA FLEUR HAND SANITIZER LEMON THYME 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 71824-1900
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
BACKHOUSIA CITRIODORA LEAF OIL (UNII: 2UQQ0PI06P)  
LEPTOSPERMUM PETERSONII LEAF OIL (UNII: N37UWG52T3)  
HYDROXYPROPYL GUAR (2500-4500 MPA.S AT 1%) (UNII: 3A1I7376TC)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
LEMON OIL, DISTILLED (UNII: ET5GD00TRP)  
LITSEA CUBEBA FRUIT (UNII: R3617MQA5Z)  
THYMUS VULGARIS LEAF (UNII: GRX3499643)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 71824-1900-11 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/13/202003/01/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph Drug505G(a)(3)08/13/202003/01/2024
PRIMA FLEUR HAND SANITIZER LEMON THYME 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 71824-1902
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
BACKHOUSIA CITRIODORA LEAF OIL (UNII: 2UQQ0PI06P)  
LEPTOSPERMUM PETERSONII LEAF OIL (UNII: N37UWG52T3)  
HYDROXYPROPYL GUAR (2500-4500 MPA.S AT 1%) (UNII: 3A1I7376TC)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
LITSEA CUBEBA FRUIT (UNII: R3617MQA5Z)  
THYMUS VULGARIS LEAF (UNII: GRX3499643)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T)  
GLYCERIN (UNII: PDC6A3C0OX)  
LEMON OIL, DISTILLED (UNII: ET5GD00TRP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 71824-1902-11 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/13/202003/01/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph Drug505G(a)(3)08/13/202003/01/2024
PRIMA FLEUR HAND SANITIZER LEMON THYME 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 71824-1916
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
BACKHOUSIA CITRIODORA LEAF OIL (UNII: 2UQQ0PI06P)  
LEPTOSPERMUM PETERSONII LEAF OIL (UNII: N37UWG52T3)  
HYDROXYPROPYL GUAR (2500-4500 MPA.S AT 1%) (UNII: 3A1I7376TC)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
LITSEA CUBEBA FRUIT (UNII: R3617MQA5Z)  
THYMUS VULGARIS LEAF (UNII: GRX3499643)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
CITRUS AURANTIUM FRUIT OIL (UNII: 59JDQ5VT0T)  
GLYCERIN (UNII: PDC6A3C0OX)  
LEMON OIL, DISTILLED (UNII: ET5GD00TRP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 71824-1916-11 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/13/202003/01/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph Drug505G(a)(3)08/13/202003/01/2024
Labeler - Prima Fleur Botanicals, Inc. (825058308)
Registrant - Prima Fleur Botanicals, Inc. (825058308)
Establishment
NameAddressID/FEIBusiness Operations
Prima Fleur Botanicals, Inc.825058308manufacture(71824-1900, 71824-1902, 71824-1908, 71824-1916)

Revised: 3/2024