Label: XTRACARE WET WIPES- benzethonium chloride swab

  • 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

    hand sanitizer to reduce bacteria on the skin.

  • KEEP OUT OF REACH OF CHILDREN

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

  • INDICATIONS & USAGE

    XtraCare Wet Wipes

    Antibacterial

    Fresh Citrus Scent

    Pocket Size

    Kills 99.9% of Germs

  • 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 eye contact occurs, rinse thoroughly with water.

    Stop use and ask a doctor if irritation and redness develops, and continues for more than 72 hours.

  • DOSAGE & ADMINISTRATION

    Directions

    for adults and children 2 years and older

    • apply to hands
    • allow to dry without wiping
    • ask a doctor before using on children under 2 years
  • INACTIVE INGREDIENT

    Inactive Ingredients

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

  • OTHER SAFETY INFORMATION

    Questions/comments? 1-855-345-5575

    DISTRIBUTED BY

    REJOICE INTERNATIONAL INC

    NORTHVILLE, MI 48168 USA

    MADE IN CHINA

  • PRINCIPAL DISPLAY PANEL

    label image

  • INGREDIENTS AND APPEARANCE
    XTRACARE WET WIPES 
    benzethonium chloride swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57337-062
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE3 mg  in 100 mg
    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:57337-062-0118 in 1 PACKAGE03/13/2014
    1100 mg in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/13/2014
    Labeler - Rejoice International (078741245)
    Establishment
    NameAddressID/FEIBusiness Operations
    China Ningbo Shangge Cosmetic Technology Corp529287434manufacture(57337-062)
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