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

  • NDC Code(s): 59062-3001-1, 59062-3001-2, 59062-3001-5
  • 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 June 10, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Benzalkonium chloride 0.12%

  • 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, propanediol, cocamidopropylamine oxide, cetrimonium chloride, pyrus malus (apple) fruit extract, aloe barbadensis leaf juice1, calendula officinalis flower extract1, chamomilla recutita (matricaria) flower extract1, olea europaea (olive) leaf extract1, glycerin, citric acid

    1
    Certified Organic Ingredient • Unless otherwise specified, product not labeled as organic.
  • PRINCIPAL DISPLAY PANEL - 249 mL Bottle Label

    babyganics®

    alcohol-free foaming
    hand sanitizer

    fragrance free

    kills 99.9% of bacteria*

    dermatologist tested

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

    8.45 FL OZ (249 mL)

    1137400

    Principal Display Panel - 249 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    BABYGANICS ALCOHOL-FREE FOAMING HAND SANITIZER 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59062-3001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.12 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    APPLE (UNII: B423VGH5S9)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CHAMOMILE (UNII: FGL3685T2X)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59062-3001-2250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/01/2022
    2NDC:59062-3001-550 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/01/2022
    3NDC:59062-3001-1473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333E06/01/2022
    Labeler - KAS Direct LLC dba BabyGanics (002764605)
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