Label: NOVALENT SHIELD ADVANCED ANTISEPTIC HAND SANITIZER- benzalkonium chloride solution

  • NDC Code(s): 90020-000-01
  • Packager: IndusCo, Ltd. (dba) Novalent Biotech
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 9, 2023

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  • Drug Facts

  • Active Ingredient

    Benzalkonium chloride 0.13%

    Purpose

    Antispetic Hand Sanitizer

  • Uses

    • Hand Sanitizer to help decrease bacteria on the skin.
    • Recommended for repeated use.
  • Warnings

    For external use only.

    Do not use

    in ears or mouth and avoid mucus membranes.

    When using this product.

    • Avoid contact with the eyes.
    • In case of contact flush eyes with water.

    Stop use and ask a doctor if

    redness or irritation develop and persist for more than 72 hours.

    Keep out of reach of children.

    Children should be supervised when using this product.

  • Directions

    • Apply a small amount into palms of hands and spread on both hands.
    • Rub into skin until dry.
  • Inactive Ingredients

    Water, 3-(Trimethoxy) Propyl Dimethyl Octadecyl Ammonium Chloride, ethoxylated alcohol, Citrus Limon (Lemon) Fruit Oil.

  • Package Labeling:

    Box

  • INGREDIENTS AND APPEARANCE
    NOVALENT SHIELD ADVANCED ANTISEPTIC HAND SANITIZER 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:90020-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CITRUS LIMON FRUIT OIL (UNII: 0HNC1J1YED)  
    DIMETHYLOCTADECYL(3-(TRIMETHOXYSILYL)PROPYL)AMMONIUM CHLORIDE (UNII: IQ36O85WQ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:90020-000-0150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)08/01/2020
    Labeler - IndusCo, Ltd. (dba) Novalent Biotech (032138240)
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