Label: ANTIBACTERIAL WIPES- benzethonium chloride swab

  • NDC Code(s): 70031-001-01, 70031-001-02, 70031-001-03, 70031-001-04, view more
    70031-001-06
  • Packager: TIANJIN YANSHENG INDUSTRIAL TRADE COMPANY
  • 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 March 19, 2022

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  • Active ingredient

    Benzalkonium chloride 0.3%

    Purpose

    Antiseptic

  • Use

    hand sanitizer to help reduce bacteria on the skin

  • Warnings

    For external use only.
    Flammabel.keep away from heat and flame.

    do not use in the eyes,in case of caotact,rinse eyes thoroughly with water.

    stop use and ask a doctor if irritation or redness develop and persist for more than 72 hours.

    Keep out of reach of children

    if swallowed

    get medical help or contact a Poison Control Center

  • Directions

    tear open packet,remove and unfold wipe.

    thoroughly wipe hands (palms ,backs and between fingers)

    supervise children in use of this product

  • INACTIVE INGREDIENT

    aloe barbadensis leaf juice,citric acid,disodium EDTA,ethyl alcohol ,fragrance,methylparaben,PEG-60 lanolin,PEG-dimethicone,potassium sorbate,propylparaben,quaternium-52,water(aqua)

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL WIPES 
    benzethonium chloride swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70031-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETIC ACID (UNII: 9G34HU7RV0)  
    ALCOHOL (UNII: 3K9958V90M)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    POTASSIUM BENZOATE (UNII: 763YQN2K7K)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70031-001-0112 in 1 BAG01/08/2018
    10.0108 g in 1 POUCH; Type 0: Not a Combination Product
    2NDC:70031-001-021 in 1 BAG01/08/2018
    20.0108 g in 1 POUCH; Type 0: Not a Combination Product
    3NDC:70031-001-031 in 1 BOTTLE, PLASTIC01/08/2018
    30.0108 g in 1 POUCH; Type 0: Not a Combination Product
    4NDC:70031-001-045 in 1 BAG01/08/2018
    40.0108 g in 1 POUCH; Type 0: Not a Combination Product
    5NDC:70031-001-066 in 1 BAG01/08/2018
    50.0108 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 finalpart333A08/05/2015
    Labeler - TIANJIN YANSHENG INDUSTRIAL TRADE COMPANY (679914791)
    Registrant - TIANJIN YANSHENG INDUSTRIAL TRADE COMPANY (679914791)
    Establishment
    NameAddressID/FEIBusiness Operations
    TIANJIN YANSHENG INDUSTRIAL TRADE COMPANY679914791manufacture(70031-001)
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