Label: COCOBATH WATERLESS- benzalkonium chloride shampoo

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated September 5, 2015

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  • ACTIVE INGREDIENT

    Benzalkonium Chloride 0.1%

  • PURPOSE

    Antibacterial

  • INDICATIONS & USAGE

    Provide sanitizing when soap and water not available
    Kill or reduces 99.9 of harmful bacteria/germs

  • DOSAGE & ADMINISTRATION

    Pump 2—3 times onto hand and rub adequately to make bubble
    Apply over top of head and wipe with towel after use

  • WARNINGS

    For external use only.
    Do not use on damaged or broken skin.
    When using this product, keep out of eyes. Rinse with water to remove.
    Stop using and ask a doctor if rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

  • INACTIVE INGREDIENT

    Cocamidopropyl Betaine, Disodium EDTA, Methylparaben, Hydrolyzed Silk, Dimethicone Copolyol, Acorus Calamus Root Extract, Rosmarinus Officinalis (Rosemary) Extract, Dipotassium Glycyrrhizate, Lactobacillus/Aloe Barbadensis Ferment Filtrate, perfume, Water

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    COCOBATH WATERLESS 
    benzalkonium chloride shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70072-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.19 g  in 191.64 g
    Inactive Ingredients
    Ingredient NameStrength
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    BOMBYX MORI FIBER (UNII: 6LK42KUV6W)  
    ACORUS CALAMUS ROOT (UNII: XY1K7KIQ0F)  
    ROSEMARY (UNII: IJ67X351P9)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70072-001-01191.64 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/05/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/05/2015
    Labeler - giod Co. (689514993)
    Registrant - giod Co. (689514993)
    Establishment
    NameAddressID/FEIBusiness Operations
    giod Co.689514993manufacture(70072-001)