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 February 18, 2016

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  • Active ingredient

    Benzalkonium chloride 0.1%

    Purpose

    Antibacterial

  • Use

    decreases bacteria on skin perfect for quick clean-ups when soap and water are not available.use anytime.

  • Warnings

    For external use only.

    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

    Keep out of reach of children. If swallowed, get

    medical help or contact aPoisonControlCenter

    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,Phenoxyethanol,Benzalkonium Chloride,Chlorhexidine digluconate,PROPYLENE GLYCOL,DECYL GLUCOSIDE,PROTEIN SOLUBILIZER 20

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL WET WIPES 
    benzalkonium chloride swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69304-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CHLORHEXIDINE (UNII: R4KO0DY52L)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69304-002-011 in 1 PACKAGE
    10.228 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/18/2016
    Labeler - Lin’an Jiameihui Cleaning Co., Ltd. (421042652)
    Registrant - Lin’an Jiameihui Cleaning Co., Ltd. (421042652)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lin’an Jiameihui Cleaning Co., Ltd.421042652manufacture(69304-002)
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