Label: ISSENGARD 24 HAND SANITIZER 3 OZ- benzalkonium chloride cream

  • 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 December 29, 2022

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  • Active Ingredient

    ACTIVE INGREDIENT

    Benzalkonium Chloride 0.18%

  • Purpose section

    Antimicrobial

  • Warnings

    For external uses only

  • Drug Facts

    Drug Facts

  • When using this product

    When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

  • Stop use and ask a doctor

    Stop use and ask a doctor if rash, irritation, or other allergic reaction occurs

  • Keep Out of Reach of Children

    Keep out of reach of children, if the product is swallowed, get medical help or contact a Poison Center right away.

  • Uses

    • to help reduce germs on the skin
    • Recommended use once a day or as needed
  • Directions

    Apply half an inch each morning on clean skin.

  • Inactive Ingredients

    Water (Aqua), Glycine soja (Soybean) Oil, Aloe Barbadensis Leaf Juice, Helianthus Annuus (Sunflower) Seed Oil, Caprylic/Capric Triglyceride, Tributyl Phosphate, Glycerin, t-Octylphenoxy-polyethoxyethanol, Hydroxy-ethylacrylate/Sodium Acryloyldimethyl Taurate, Copolymer, Isohexadecane, Polysorbate 60, Glyceryl Stearate, Stearic Acid, Stearyl Alcohol, Lavandula angustifolia (Lavender) Oil, Propylene Glycol, Ethyl Alcohol, Zinc Oxide CI 77947

  • Principal Display Panel - 30 mL

    ISSENGARD

    Hand Cream Protectant

    Kills > 99.99% of Germs

    Non-alcohol HAND SANITIZER

    1 FL OZ / 30 mL

    Made in USA

    Issengard 1 oz front label

    Issengard 1 oz back label

  • INGREDIENTS AND APPEARANCE
    ISSENGARD 24 HAND SANITIZER 3 OZ 
    benzalkonium chloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81495-112
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.18 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    OCTOXYNOL-1 (UNII: 20CAX7IO75)  
    ALCOHOL (UNII: 3K9958V90M)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    TRI-N-BUTYL PHOSPHATE (UNII: 95UAS8YAF5)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81495-112-0130 mL in 1 TUBE; Type 0: Not a Combination Product01/31/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/03/2022
    Labeler - CLEAR LAKE RESEARCH, LLC (077493647)
    Establishment
    NameAddressID/FEIBusiness Operations
    Clear Lake Research, LLC077493647label(81495-112)
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