Label: WET WIPES- benzethonium 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 13, 2019

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  • ACTIVE INGREDIENT

    Active Ingredient                                    Purpose

    Benzethonium Chloride 0.3% ............... Antibacterial

  • PURPOSE

    Uses

    decrease bacteria on skin

  • KEEP OUT OF REACH OF CHILDREN

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

  • INDICATIONS & USAGE

    XtraCare Wet Wipes

    Antibacterial Hand Wipes

    Citrus Scent

    Kills 99.9% of germs

    Pull up here

    Resealable

    32 Thick Moist Wipes

    14.6 cm x 19 cm

    XtraCare Antibacterial Hand Wipes kill 99.9% of germs, helping prevent the spread of bacteria, and they remove dirt, providing a better clean-up after hand sanitizers. They are ideal for quick clean-ups after contact with germs, sticky foods, greasy dirt and everyday messes.

    XtraCare Antibacterial Hand Wipes are formulated to be tough on dirt and germs, yet gentle on skin. Help keep your family healthy and clean anytime and anywhere, when soap and water are not available.

  • WARNINGS

    Warnings

    For external use only

    Do not use 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.

  • DOSAGE & ADMINISTRATION

    Directions

    adults and children 2 years and over

    • apply to hands
    • allow to dry without wiping

    children under 2 years

    • ask a doctor before use
  • INACTIVE INGREDIENT

    Inactive Ingredients

    water, ethyl alcohol, propylene glycol, PEG-40 hydrogenated castor oil, fragrance, disodium EDTA, aloe barbadensis leaf juice, methylparaben, propylparaben.

  • PRINCIPAL DISPLAY PANEL

    label image

  • INGREDIENTS AND APPEARANCE
    WET WIPES 
    benzethonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57337-066
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.3 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57337-066-0132 in 1 PACKAGE; Type 0: Not a Combination Product12/08/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E12/08/2014
    Labeler - Rejoice International (078741245)
    Establishment
    NameAddressID/FEIBusiness Operations
    China Ningbo Shangge Cosmetic Technology Corp529287434manufacture(57337-066)
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