Label: ANTIBACTERIAL MOIST WIPE - benzalkonium chloride swab

  • NDC Code(s): 33992-2100-0
  • Packager: Greenbrier International, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 10/13

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Benzalkonium chloride 0.1%

    Purpose

    Antibacterial

    Close
  • Use

    decreases bacteria on skin

    Close
  • Warnings

    For external use only.

    Close
  • Do not use

    • over large areas of the body
    • if you are allergic to any of the ingredients
    Close
  • When using this product

    avoid contact with eyes.

    In contact occurs, flush thoroughly with water.

    Close
  • Stop use and ask a doctor if

    irritation or rash develops and continues for more than 72 hours

    Close
  • Keep out of reach of children.

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

    Close
  • Directions

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

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

    Close
  • Antibacterial Moist Wipes 20 count (33992-2100-0)
  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL MOIST WIPE  
    benzalkonium chloride swab
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:33992-2100
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE 1 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    SODIUM LAURYL SULFATE  
    BRONOPOL  
    ALOE VERA LEAF  
    EDETATE DISODIUM  
    TROLAMINE  
    GLYCERIN  
    .ALPHA.-TOCOPHEROL ACETATE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:33992-2100-0 80 mL in 1 PACKAGE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 10/10/2012
    Labeler - Greenbrier International, Inc. (610322518)
    Close