Label: ANTIBACTERIAL WET WIPES- benzalkonium 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 May 7, 2020

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  • Active ingredient

    Benzalkonium chloride 0.1%...........Antiseptic 

    Purpose

    Antibacterial

  • Use

    decreases bacteria on skin

  • Warnings

    For external use only.

    Keep out of reach of children

    if swallowed

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

  • 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

  • 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, poly(hexamethyleneguanidine),PEG-7 glyceryl cocoate ,

    hydrochloride, glycine, tetrasodium EDTA,  tocopheryl acetate, citric acid,

    fragrance, methylchloroisothiazolinone, methylisothiazolinone,

    PEG-40 hydrogenated castor oil.

  • PRINCIPAL DISPLAY PANEL

    wet wipes

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL WET WIPES 
    benzalkonium chloride swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76772-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
    2-METHYL-1,2-BENZOISOTHIAZOLIN-3-ONE (UNII: 81PV9X5Y68)  
    PEG-40 HYDROGENATED LANOLIN (UNII: 959P5CXE48)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    WATER (UNII: 059QF0KO0R)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76772-008-4040 in 1 PACKAGE; Type 0: Not a Combination Product05/07/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/07/2020
    Labeler - TSM ITHALAT IHRACAT SANAYI VE DIS TICARET LIMITED SIRKETI (533120570)
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