Label: MOISTURIZING HAND SANITIZER- benzethonium chloride lotion

  • NDC Code(s): 11344-478-16, 11344-478-26, 11344-478-32
  • Packager: Vi-Jon, LLC
  • 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 September 7, 2022

If you are a consumer or patient please visit this version.

  • Active ingredient

    Benzethonium chloride 0.2%

  • Purpose

    Antimicrobial

  • Uses

    • to decrease bacteria on the skin that could cause disease
    • recommended for repeated use
  • Warnings

    For external use only - hands only

  • When using this product

    • Keep out of eyes. In case of contact with eyes, flush thoroughly with water.
    • avoid contact with broken skin
  • 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
    • briskly rub hands together until absorbed
    • apply to hands as needed
    • for children under 6, use only under adult supervision
    • not recommended for infants
  • Inactive ingredients

    water, dimethicone, cetyl alcohol, cyclopentasiloxane, stearyl alcohol, polyquaternium-37, cocamidopropyl PG-dimonium chloride phosphate, glyceryl laurate, butylene glycol, Vitis vinifera (grape) seed oil, tocopheryl acetate, Butyrospermum parkii (shea) butter extract, Chamomilla recutita (matricaria) flower extract, Aloe barbadensis leaf juice, Camellia oleifera leaf extract, Thymus vulgaris (thyme) flower/leaf oil, Melaleuca alternifolia (tea tree) leaf oil, Litsea cubeba fruit oil, Origanum vulgare oil, cholecalciferol, ascorbic acid, retinyl palmitate, glycerin, glyceryl caprylate/caprate, propylene glycol, glyceryl stearate SE, steareth-2, steareth-21, polysorbate 20, beeswax, ethylhexylglycerin, ethylhexyl palmitate, tetrasodium EDTA, phenoxyethanol, methylparaben, ethylparaben, imidazolidinyl urea, DMDM hydantoin, potassium sorbate, sodium benzoate, citric acid

  • Rear label text

    *Effective at eliminating 99.99% of many common harmful germs and bacteria in as little as 15 seconds

    Distributed By: Vi-Jon, Inc.

    8515 Page Ave

    St. Louis, MO 63114

    www.germx.com

  • principal display panel

    germ-X Moisturizing Hand Sanitizer Lotion

    2 in 1 moisturize & sanitize hands

    KILLS 99.99% OF GERMS

    Fragrance Free

    Alcohol Free

    Dermatologist Tested

    NET WT 2 OZ (59 g)

    image description

  • INGREDIENTS AND APPEARANCE
    MOISTURIZING HAND SANITIZER 
    benzethonium chloride lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11344-478
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE1.98 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    POLYQUATERNIUM-37 (10000 MPA.S) (UNII: 41QWS48DFN)  
    COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
    GLYCERYL LAURATE (UNII: Y98611C087)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CHAMOMILE (UNII: FGL3685T2X)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
    THYME OIL (UNII: 2UK410MY6B)  
    TEA LEAF OIL (UNII: VC855RRT77)  
    LITSEA CUBEBA FRUIT (UNII: R3617MQA5Z)  
    LITSEA OIL (UNII: 2XIW34BN6O)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    glyceryl caprylate/caprate (UNII: G7515SW10N)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    STEARETH-2 (UNII: V56DFE46J5)  
    Steareth-21 (UNII: 53J3F32P58)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    IMIDUREA (UNII: M629807ATL)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11344-478-1656 g in 1 TUBE; Type 0: Not a Combination Product05/03/2016
    2NDC:11344-478-26113 g in 1 TUBE; Type 0: Not a Combination Product05/03/2016
    3NDC:11344-478-32340 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/03/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/03/2016
    Labeler - Vi-Jon, LLC (790752542)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(11344-478)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(11344-478)