Label: MERINGUE FOAMING DYE FREE ANTIBACTERIAL- choroxylenol liquid

  • NDC Code(s): 63998-758-01
  • Packager: United Laboratories Inc.
  • 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 December 22, 2022

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  • Active ingredient

    Chloroxylenol 0.25%

  • Purpose

    Antibacterial

  • Uses:

    For hand washing to decrease bacteria on the skin.

  • Warnings:

    For external use only

    When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

    Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

    Keep out of reach of children. Children must be surpervised in use of this product. If swallowed, get medical help or contact a Poison Control center right away.

  • Directions:

    For maximum efficiency, pump foam into dry hands, later vigorously for 30 seconds, rinse and dry.

  • Other Information:

    Store at 20 to 25 C [68 to 77 F]

  • Inactive ingredients:

    Water, Sodium Lauryl Ether Sulfate, Decyl Glucoside, Cocamidopropyl Betaine, Fragrance, Propylene Glycol and Preservative

  • PRINCIPAL DISPLAY PANEL

    UNITED

    Laboratories

    United 758

    MERINGUE

    Foaming Dye Free

    Antibacterial

    Hand Soap

    750 ml (25 fl.oz.) Made in USA 1018

    container label

  • INGREDIENTS AND APPEARANCE
    MERINGUE FOAMING DYE FREE ANTIBACTERIAL 
    choroxylenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63998-758
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL2.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63998-758-01750 mL in 1 BOTTLE; Type 0: Not a Combination Product12/22/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/22/2022
    Labeler - United Laboratories Inc. (001759737)
    Establishment
    NameAddressID/FEIBusiness Operations
    Woodbine Products Company004220323manufacture(63998-758)