Label: BABY SHARK ANTIBACTERIAL HAND SANITIZING WIPES- benzalkonium chloride cloth

  • 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 September 2, 2020

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  • Active ingredient

    Benzalkonium chloride 0.12%

    Purpose

    Antibacterial

  • Use

    decreases bacteria on skin

  • Warnings

    For external use only.

    Do not use over large areas of the body

    if you are allergic to any of the ingredients.

    When using this product do not get into eyes.

    If contact occurs, rinse thoroughly with water.

    Stop use and ask a doctor if irritation or rash

    develops and continues for more than 72 hours.
    Keep out of reach of children.
    If swallowed, get medical help or contact
    a Poison Control Center right away.

    Keep out of reach of children

    if swallowed

    get medical help or contact a Poison Control Center right away.

  • Directions

    For adults and children of 2 years and over use

    on hands and face to clean and refresh, allow

    skin to air dry.

    For children under 2 years ask a doctor before use.

  • INACTIVE INGREDIENT

    Water, Propylene glycol, Cocamidopropyl betaine,
    Aloe barbadensis leaf extract, Tocopheryl acetate,
    Polysorbate 20, Polyaminopropyl biguanide,
    Phenoxyethanol, Disodium EDTA, lodopropynyI
    butylcarbamate, Citric acid.

  • PRINCIPAL DISPLAY PANEL

    4321

  • INGREDIENTS AND APPEARANCE
    BABY SHARK ANTIBACTERIAL HAND SANITIZING WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42255-902
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.12 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    POLYAMINOPROPYL BIGUANIDE (UNII: DT9D8Z79ET)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42255-902-0124 in 1 CARTON09/02/2020
    120 in 1 BAG
    14.8 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    2NDC:42255-902-0224 in 1 CARTON09/02/2020
    230 in 1 BAG
    24.8 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    3NDC:42255-902-0324 in 1 CARTON09/02/2020
    340 in 1 BAG
    34.8 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    4NDC:42255-902-0424 in 1 CARTON09/02/2020
    450 in 1 BAG
    44.8 g in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/02/2020
    Labeler - ZHEJIANG GREENFACE HOUSEWARES CO., LTD. (546596567)
    Establishment
    NameAddressID/FEIBusiness Operations
    ZHEJIANG GREENFACE HOUSEWARES CO., LTD.527999264manufacture(42255-902)
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