Label: CLEAN MONSTER LAVENDER PEPPERMINT HAND SANITIZER- ethanol liquid

  • 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 June 1, 2020

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  • ACTIVE INGREDIENT

    Ethanol 70%

  • Purpose:

    Antiseptic

  • Uses:

    Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • WARNINGS:

    For external use only. Flammable. Keep away from heat or flame.

    Do not use

    • In children less than 2 months of age
    • On open skin wounds

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

    Keep out of reach of children. If swallowed, get medical help or contact the Poison Control Center right away.

  • Directions:

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.

  • STORAGE AND HANDLING

    Store at room temperature 20-25 °C (66-77 °F)

  • Inactive Ingredients:

    Aqua, Glycerin, Lavandula Angustifolia (Lavender) Oil, Mentha piperita (Peppermint) Oil, Tocopherol.

  • PRINCIPAL DISPLAY PANEL

    Clean Monster

  • INGREDIENTS AND APPEARANCE
    CLEAN MONSTER LAVENDER PEPPERMINT HAND SANITIZER 
    ethanol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78723-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78723-001-0259 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/01/2020
    2NDC:78723-001-04118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product06/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/01/2020
    Labeler - Clean Monster LLC (131398718)
    Establishment
    NameAddressID/FEIBusiness Operations
    GPS Associates096942063manufacture(78723-001)
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