Label: SUNDROPS 77- benzalkonium chloride soap

  • NDC Code(s): 63621-354-70, 63621-354-85
  • Packager: Sunburst Chemicals, Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated May 14, 2024

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  • Active Ingredient

    Benzalkonium Chloride 0.1%

  • Purpose

    Antimicrobial

  • Uses

    • For hand sanitizing to decrease bacteria on the skin
    • Recommended for repeated use
  • Warnings

    For external use only.

    When using this product avoid contact with eyes. In case of eye contact, flush eyes with water.

    Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Pump a small amount of foam into palm of hand.
    • Rub thoroughly over all surfaces of both hands.
    • Rub hands together briskly until dry.
  • Inactive Ingredients

    Water, Cocamidopropyl PG-Dimonium Chloride Phosphate, Dihydroxyethyl Cocamine Oxide, Acetamidoethoxyethanol, Fragrance, Citric Acid

  • PRINCIPAL DISPLAY PANEL

    Case Label - 8 x 1000 mL Bags

  • INGREDIENTS AND APPEARANCE
    SUNDROPS 77 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63621-354
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
    DIHYDROXYETHYL COCAMINE OXIDE (UNII: 8AR51R3BL5)  
    ACETAMIDOETHOXYETHANOL (UNII: LVX2APC4XR)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Product Characteristics
    Colorwhite (water white - colorless, dispensed as a white foam) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63621-354-858 in 1 BOX09/28/2012
    11000 mL in 1 BAG; Type 0: Not a Combination Product
    2NDC:63621-354-706 in 1 BOX05/08/200806/30/2022
    2500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)05/05/2008
    Labeler - Sunburst Chemicals, Inc. (006159339)
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