Label: MONK HAND SANITIZING WIPES- benzethonium chloride cloth

  • 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 6, 2010

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    MM1

    Label



  • ACTIVE INGREDIENT

    Active Ingredients:
    Benzethonium Chloride (0.3%)
  • PURPOSE

    Purpose:

    Antibacterial

  • DOSAGE & ADMINISTRATION

    Use decreases bacteria on skin

  • WARNINGS

    Warnings For external use only

  • DO NOT USE

    Do not use
    • over large areas
    • If you are allergic to any of the ingredients
  • WHEN USING

    When using this product

    • do not get into eyes
    If contact occurs, rinse thoroughly with water
  • STOP USE

    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 Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions: Adults and children 2 years and over: apply on hands and face to clean and refresh. Allow skin to dry without wiping. Children under 2 years: as a doctor before use. For Children under 6 use only under supervision.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, SD Alcohol 40-B, Sodium Benzoate, Diazolidinyl Urea, Glycerin, Propylene Glycol, Potassium Sorbate, Disodium EDTA, Tocopheryl Acetate, Aloe

  • STORAGE AND HANDLING

    Store under 110 F

  • QUESTIONS

    Questions and Comments: For products or technical information, contact National Towelette Monday to Friday 8 AM to 4 PM EST at 1-800-738-9068, or visit our website at www.towelettes.com

  • INGREDIENTS AND APPEARANCE
    MONK  HAND SANITIZING WIPES
    benzethonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50320-111
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzethonium Chloride (UNII: PH41D05744) (Benzethonium - UNII:1VU15B70BP) Benzethonium Chloride30 mL  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R) 879 mL  in 1000 mL
    Ethanol (UNII: 3K9958V90M) 111.60 mL  in 1000 mL
    Sodium Benzoate (UNII: OJ245FE5EU) 1.30 mL  in 1000 mL
    Diazolidinylurea (UNII: H5RIZ3MPW4) 1.30 mL  in 1000 mL
    Glycerin (UNII: PDC6A3C0OX) 1.00 mL  in 1000 mL
    Propylene Glycol (UNII: 6DC9Q167V3) 1.00 mL  in 1000 mL
    Potassium Sorbate (UNII: 1VPU26JZZ4) .75 mL  in 1000 mL
    Edetate Disodium (UNII: 7FLD91C86K) .45 mL  in 1000 mL
    Alpha-Tocopherol Acetate (UNII: 9E8X80D2L0) 0.10 mL  in 1000 mL
    Aloe (UNII: V5VD430YW9) 0.09 mL  in 1000 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50320-111-58500 mL in 1 CANISTER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33301/06/2010
    Labeler - National Towelette Company (782795041)
    Registrant - National Towelette Company (782795041)
    Establishment
    NameAddressID/FEIBusiness Operations
    National Towelette Company782795041repack
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