Label: PRE FENSE UNSCENTED- benzalkonium chloride liquid

  • NDC Code(s): 48404-050-01, 48404-050-02, 48404-050-03
  • Packager: Prefense LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 2, 2023

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  • PURPOSE

    Hand and Skin Sanitizer

  • ACTIVE INGREDIENT

    Drug Facts

    Active Ingredient

    Benzalkonium Chloride ............0.12%

  • INDICATIONS & USAGE

    Hand sanitizer to help reduce germs that potentially cause disease.

  • WARNINGS

    For external use only. Avoid contact with eyes. In case of eye contact, flush with water. Discontinue use if irritation or redness occurs.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    Apply to dry hands, rub together, and let dry.

  • INACTIVE INGREDIENT

    3-Chloropropyltrimethoxysilane, Acetic Acid, Anhydrous Citric Acid, Cocomidoprophyl betaine, Octadecyldimethyl (3-trimethoxysilylpropyl)ammonium chloride, Isotonic Sodium Chloride Solution, Water

  • Package Label - 1.5 FL. OZ. BOTTLE LABEL

    pre•fense ™

    Hand Sanitizer

    Unscented

    protects

    kills up to 99.99% of germs on contact

    Moisturizes

    silica based, alcohol-free

    alcohol-free

    won't dry out skin

    120 Pumps

    1.5 fl. oz.

    1

  • INGREDIENTS AND APPEARANCE
    PRE FENSE UNSCENTED 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48404-050
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE120 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    WATER (UNII: 059QF0KO0R)  
    (3-CHLOROPROPYL)TRIMETHOXYSILANE (UNII: T21BNL1S7F)  
    ISOTONIC SODIUM CHLORIDE SOLUTION (UNII: VR5Y7PDT5W)  
    METHYL ALCOHOL (UNII: Y4S76JWI15)  
    DIMETHYLOCTADECYL(3-(TRIMETHOXYSILYL)PROPYL)AMMONIUM CHLORIDE (UNII: IQ36O85WQ4)  
    ACETIC ACID (UNII: Q40Q9N063P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:48404-050-0144.4 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
    2NDC:48404-050-02236.6 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
    3NDC:48404-050-03502.8 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)05/15/2020
    Labeler - Prefense LLC (832498625)
    Registrant - Prefense LLC (832498625)
    Establishment
    NameAddressID/FEIBusiness Operations
    Reynolds Engineering807186333manufacture(48404-050) , label(48404-050) , pack(48404-050)
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