Label: PRIMA FLEUR HAND SANITIZER LEMON THYME- ethyl alcohol gel

  • NDC Code(s): 71824-1900-1, 71824-1902-1, 71824-1908-1, 71824-1916-1
  • Packager: Prima Fleur Botanicals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 1, 2024

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  • 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

  • INGREDIENTS AND APPEARANCE
    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 Product08/13/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)08/13/2020
    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 Product08/13/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)08/13/2020
    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 Product08/13/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)08/13/2020
    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 Product08/13/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)08/13/2020
    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)
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