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

  • NDC Code(s): 59062-3000-1, 59062-3000-2, 59062-3000-5
  • 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 July 23, 2020

If you are a consumer or patient please visit this version.

View All Sections
  • 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, flush eyes with water.

    Stop use and ask a doctor if irritation or redness develops, or if condition persists 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

  • SPL UNCLASSIFIED SECTION

    dist. by KAS direct, LLC
    Westbury, NY 11590

  • PRINCIPAL DISPLAY PANEL - 250 mL Bottle Label

    babyganics™
    alcohol-free
    foaming hand sanitizer
    fragrance free

    moisturizing formula • non-allergenic
    kills 99.9% of germs* • dermatologist tested

    formulated without: parabens • sulfates
    phthalates • dyes • fragrances

    Discover which of our ingredients are
    Certified Organic on back panel.

    8.45 FL OZ (250 mL)
    040-10050-B02

    Principal Display Panel - 250 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    BABYGANICS ALCOHOL FREE FOAMING HAND SANITIZER 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59062-3000
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59062-3000-550 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/15/2013
    2NDC:59062-3000-2250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/15/2013
    3NDC:59062-3000-1473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/15/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333E08/15/2013
    Labeler - KAS Direct LLC dba BabyGanics (002764605)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!