Label: PRIMA FLEUR HAND SANITIZER BERGAMOTI NEROLI- ethyl alcohol gel

  • NDC Code(s): 71824-1800-1, 71824-1802-1, 71824-1808-1, 71824-1816-1
  • Packager: Prima Fleur Botanicals, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 31, 2024

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  • 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

  • INGREDIENTS AND APPEARANCE
    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)
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