Label: HAND SANITIZER- benzalkonium chloride gel

  • 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 October 9, 2020

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  • Active Ingredient(s)

    Benzalkonium Chloride 0.10% w/w. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    To eliminate viruses and bacteria on the skin

  • Warnings

    For external use only.

  • WHEN USING

    When using this product keep out of eyes. In case of contact, flush eyes with water.

    Stop use and ask a doctor if irritation or redness develops

    Keep out of reach of children. If swallowed, get medical assistance or contact a Poison Control Center immediately.

  • STOP USE

    Stop use and ask a doctor if irritation or redness develops.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical assistance or contact a Poison Control Center immediately.

  • Directions

    • Rub thoroughly over all surfaces of both hands.
    • Rub hands toghether briskly unitl dry.
  • Inactive ingredients

    Aloe Barbadensis Leaf Juice, Citrus Sinensis (Orange) Fruit Oil, Cocamidopropyl PG-Dimonium Chloride Phosphate, Glycerin, Hydroxyethylcellulose, PEG-8, PEG-90, Potassium Sorbate, Polysorbate 20, Purified Water, Quercus Borealis Bark Extract

  • Package Label - Principal Display Panel

    118 mL Sanitizer Label

  • Impact Diversity Solutions Label

    118 mL Impact Sanitizer

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    benzalkonium chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77238-221
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95) 2.2 g  in 100 mL
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) 1.8 g  in 100 mL
    WATER (UNII: 059QF0KO0R)  
    QUERCUS RUBRA BARK (UNII: X26K8566JX) 1 g  in 100 mL
    POLYSORBATE 20 (UNII: 7T1F30V5YH) 0.2 g  in 100 mL
    COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4) 1 g  in 100 mL
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 1 g  in 100 mL
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D) 0.7 g  in 100 mL
    ORANGE OIL (UNII: AKN3KSD11B) 0.1 g  in 100 mL
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 0.05 g  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77238-221-14118 mL in 1 BOTTLE; Type 0: Not a Combination Product06/22/2020
    2NDC:77238-221-24118 mL in 1 BOTTLE; Type 0: Not a Combination Product10/05/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/22/2020
    Labeler - DGH Pharma, Inc. (128884560)
    Registrant - DGH Pharma, Inc. (128884560)
    Establishment
    NameAddressID/FEIBusiness Operations
    DGH Pharma, Inc.128884560manufacture(77238-221)
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