Label: BABYGANICS KIDS ALCOHOL FREE FOAMING HAND SANITIZER BERRY BERRY- benzalkonium chloride liquid
BABYGANICS KIDS ALCOHOL FREE FOAMING HAND SANITIZER CUPCAKE- benzalkonium chloride liquid

  • NDC Code(s): 59062-4100-1, 59062-4200-1
  • Packager: KAS Direct LLC dba BabyGanics
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 15, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Benzalkonium chloride 0.1%

  • Purpose

    Antimicrobial

  • Uses

    • for hand sanitizing to decrease bacteria on the skin
    • recommended for repeated use
  • Warnings

    For external use only

    When using this product avoid contact with eyes. In case of eye contact, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation or redness develops, or if condition lasts for more than 72 hours

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • pump a small amount of foam into palm of hand
    • rub thoroughly over all surfaces of both hands
    • rub hands together briskly until dry
  • Inactive ingredients

    water, cetrimonium chloride, laurtrimonium chloride, dihydroxyethyl cocamine oxide, glycereth-17 cocoate, citric acid, fragrance1

    1
    Learn about these and all our ingredients and the choices we make at babyganics.com/products
  • SPL UNCLASSIFIED SECTION

    dist. by KAS Direct, LLC
    San Francisco, CA 94111

  • PRINCIPAL DISPLAY PANEL - 249 mL Bottle Label - Berry Berry

    kids
    by babyganics®

    hand sanitizer
    berry berry

    kills 99.9% of bacteria*

    alcohol-free, moisturizing

    Discover which of our
    ingredients are certified organic
    on the back panel.

    8.45 FL OZ (249 mL)

    1123758

    PRINCIPAL DISPLAY PANEL - 249 mL Bottle Label - Berry Berry
  • PRINCIPAL DISPLAY PANEL - 249 mL Bottle Label - Cupcake

    kids
    by babyganics®

    hand sanitizer
    cupcake

    kills 99.9% of bacteria*

    alcohol-free, moisturizing

    Discover which of our
    ingredients are certified organic
    on the back panel.

    8.45 FL OZ (249 mL)

    1123771

    PRINCIPAL DISPLAY PANEL - 249 mL Bottle Label - Cupcake
  • INGREDIENTS AND APPEARANCE
    BABYGANICS KIDS ALCOHOL FREE FOAMING HAND SANITIZER BERRY BERRY 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59062-4100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
    DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)  
    GLYCERETH-17 COCOATE (UNII: 3057VPT0KC)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59062-4100-1250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product02/15/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333E02/15/2021
    BABYGANICS KIDS ALCOHOL FREE FOAMING HAND SANITIZER CUPCAKE 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59062-4200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    LAURTRIMONIUM CHLORIDE (UNII: A81MSI0FIC)  
    DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)  
    GLYCERETH-17 COCOATE (UNII: 3057VPT0KC)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59062-4200-1250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product02/15/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333E02/15/2021
    Labeler - KAS Direct LLC dba BabyGanics (002764605)
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