Label: ANTIBACTERIAL MOIST WIPE- benzalkonium chloride swab

  • Category: HUMAN OTC DRUG LABEL

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 October 10, 2013

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  • Active Ingredient

    Benzalkonium chloride 0.1%

    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

    avoid contact with eyes.

    In contact occurs, flush 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.

  • Directions

    • for adults and children of 2 years and over
    • children under 2 years ask a doctor before use
    • allow to dry without wiping
  • Inactive ingredient

    Water, Sodium Lauryl sulfate, Fragrance, 2-Bromo-2-Nitropropane-1, 3-Diol, Aloe Barbadensis Leaf Extract, Disodium EDTA, Triethanolamine, Glycerin, Tocopheryl Acetate

  • Antibacterial Moist Wipes 20 count (33992-2100-0)

    DrugFacts

    PackageLabel

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL MOIST WIPE  
    benzalkonium chloride swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-2100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    BRONOPOL (UNII: 6PU1E16C9W)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:33992-2100-080 mL in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/10/2012
    Labeler - Greenbrier International, Inc. (610322518)
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