Label: 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 January 17, 2020

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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 and face.

    If 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

    Keep out of reach of children. If swallowed, get medical help or contact aPoisonControlCenter right away.

  • Directions

    Foradults 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,trithanolamine ,glycerin,tocopheryl acetate

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    WET WIPES 
    benzalkonium chloride swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71198-001
    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
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    2-BROMO-2-NITROETHANOL (UNII: FA22WV2B2Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
    COPPER TRIETHANOLAMINE (UNII: YBM44X0B6H)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71198-001-0110 in 1 PACKAGE02/13/2017
    10.042 g in 1 POUCH; Type 0: Not a Combination Product
    2NDC:71198-001-0215 in 1 PACKAGE02/13/2017
    20.06 g in 1 POUCH; Type 0: Not a Combination Product
    3NDC:71198-001-0330 in 1 PACKAGE02/13/2017
    30.126 g in 1 POUCH; Type 0: Not a Combination Product
    4NDC:71198-001-0580 in 1 PACKAGE02/13/2017
    40.336 g in 1 POUCH; Type 0: Not a Combination Product
    5NDC:71198-001-0450 in 1 PACKAGE02/13/2017
    50.21 g in 1 POUCH; Type 0: Not a Combination Product
    6NDC:71198-001-06100 in 1 PACKAGE02/13/2017
    60.42 g in 1 POUCH; Type 0: Not a Combination Product
    7NDC:71198-001-071200 in 1 PACKAGE02/13/2017
    75.04 g in 1 POUCH; Type 0: Not a Combination Product
    8NDC:71198-001-0850 in 1 BOTTLE02/13/2017
    80.21 g in 1 POUCH; Type 0: Not a Combination Product
    9NDC:71198-001-0980 in 1 BOTTLE02/13/2017
    90.336 g in 1 POUCH; Type 0: Not a Combination Product
    10NDC:71198-001-10100 in 1 BOTTLE02/13/2017
    100.42 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 finalpart333A02/13/2017
    Labeler - HANGZHOU BRIGHT DAILY CHEMICAL CO.,LTD (543255067)
    Establishment
    NameAddressID/FEIBusiness Operations
    HANGZHOU BRIGHT DAILY CHEMICAL CO.,LTD543255067manufacture(71198-001)