Label: KLEEN FREAK HAND SANITIZER- alcohol 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 July 18, 2020

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  • Drug Facts

  • Active ingredient

    Alcohol 75% (V/V)

  • Purpose

     Antibacterial

  • Use

    Hand sanitizer to help reduce germs on the skin that an potntially cause disease. Use when soap and water are not available

  • Warnings

    For external use only.

    Flammable,

    Keep away from fire or flame

    When using this product do not use in or near the eyes

    In case of contact, rinse eyes thoroughly with water.

    Discontinue use and ask a doctor if

    irritation or rash appears and lasts. 

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

    Directions

    • Wet hands thoroughly with product.
    • Rub hands together for no less than 15 seconds
    • Allow to dry without wiping or rub hands together briskly until dry
    • Store in a cool dry place below 104℉
  • Inactive ingredients

    Capom, Propylene Glycol, Allantoin, EDTA-2Na, Trimethylglycine, Methyl ESter, Sodium Hydroxide, DMDM Hydantoin, PEG-40 Hydrogenated Castor Oil

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    KLEEN FREAK HAND SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74447-106
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALLANTOIN (UNII: 344S277G0Z)  
    BETAINE (UNII: 3SCV180C9W)  
    METHYL 2-FUROATE (UNII: O9A8D29YDE)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74447-106-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product07/18/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/18/2020
    Labeler - Guangzhou Minghui Cosmetics Co., Ltd. (402686508)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Minghui Cosmetics Co., Ltd.402686508manufacture(74447-106)
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