SANITIZING HAND- benzethonium chloride lotion

Drug Labeling and Warnings

Drug Details [pdf]

  • Directions For Use

    - Press dispensing pump to release product into hands, and rub thoroughly around both sides of hands and between fingers. Do not wipe off. Let air dry.

    - For adults and children 2 years and over.

    - For children under 2 years of age, consult a doctor before use

  • PRINCIPAL DISPLAY PANEL - 400 ml Bottle Label

    PURIGEN™

    Sanitizing
    Hand Lotion

    • Kills 99.9% of Germs
    • Safe for Sensitive Skin
    • Dual Use Sanitizer & Moisturizer

    Paraben Free
    No Artificial Fragrance
    Made with Organic Ingredients

    13.5 fl oz (400 ml)

    PRINCIPAL DISPLAY PANEL - 400 ml Bottle Label
  • INGREDIENTS AND APPEARANCE
    SANITIZING HAND 
    benzethonium chloride lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 80994-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE0.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    LICORICE (UNII: 61ZBX54883)  
    CHAMOMILE (UNII: FGL3685T2X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-AMINOBUTYRIC ACID, L- (UNII: 0QAJ5KN9IM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 80994-002-01250 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
    2NDC: 80994-002-02400 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
    3NDC: 80994-002-033785 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2020
    4NDC: 80994-002-04150 in 1 BOX05/01/2020
    41.2 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333A05/01/2020
    Labeler - BELLA BRANDS INC (034908755)
    Establishment
    NameAddressID/FEIBusiness Operations
    BELLA BRANDS INC034908755MANUFACTURE(80994-002)

  • © 2020 FDA.report
    This site is not affiliated with or endorsed by the FDA.