Label: LUSTI SKIN SOFTENING HAND SANITIZER- ethyl alcohol liquid

  • NDC Code(s): 49681-400-04
  • Packager: New Life Products, 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 February 2, 2023

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  • Drug Facts

  • Active ingredient

    Ethyl Alcohol 65%

  • Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Use • Hand sanitizer to decrease bacteria on skin • Recommended for repeated use

  • WARNINGS

    Warnings • For external use only. Flammable.

    Keep away from fire or flame.

    When using this product avoid contact with face, eyes and broken skin. If eye contact occurs, flush thoroughly with water and seek medical advice.

    Stop use and ask a doctor if irritation and redness develops.

    Keep out of reach of children

  • DOSAGE & ADMINISTRATION

    Directions• Wet hands thoroughly with product and rub into skin until dry.

    • Children under 6 years of age should be supervised by an adult when using this product

  • Inactive ingredients

    Water (Aqua), Isopropyl Alcohol, Glycerin, Carbomer, Aminomethyl Propanol, Mentha Piperita (Peppermint) Oil, Panthenol, Tocopheryl Acetate, Fragrance(Parfum).

  • SPL UNCLASSIFIED SECTION

    ADVANCED FORMULA

    with PEPPERMINT OIL

    KILLS GERMS FAST &

    LEAVES HANDS SOFT & PROTECTED

    JF LABS INC. Chicago,IL 60629

    (800)262-2326 Watford WD247GN, UK

    www.afamconcept.com ISO and cGMP compliant

    MADE IN USA

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    LUSTI SKIN SOFTENING HAND SANITIZER 
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49681-400
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49681-400-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product05/25/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/25/2020
    Labeler - New Life Products, Inc. (117815140)
    Establishment
    NameAddressID/FEIBusiness Operations
    New Life Products, Inc.117815140manufacture(49681-400)
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