Label: SOLDANIZER DN-723- benzalkonium chloride spray

  • 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 January 10, 2023

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  • ACTIVE INGREDIENT

    BENZALKONIUM CHLORIDE 0.13%

  • PURPOSE

    ANTIMICROBIAL

  • USES

    • HAND SANITIZER HELPS REDUCE BACTERIA ON THE SKIN.
    • CAN BE USED REPEATEDLY.
  • WARNINGS

    FOR EXTERNAL USE ONLY.

    AVOID CONTACT WITH OR NEAR EYES WHEN USING THIS PRODUCT. IN CASE OF CONTACT, RINSE EYES THOROUGHLY WITH WATER.

    IF IRRITATION OR RASH APPEARS, OR IF CONDITION PERSISTS, STOP USE AND CONTACT A DOCTOR.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

    IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

  • DIRECTIONS

    • SPRAY PRODUCT INTO THE PALM OF HAND.
    • RUB HANDS TOGETHER THOROUGHLY UNTIL DRY.
    • SUPERVISE CHILDREN UNDER 6 YEARS OF AGE WHEN USING PRODUCT.
  • INACTIVE INGREDIENTS

    WATER, DIDECYL DIMETHYL AMMONIUM CHLORIDE, PROPYLENE GLYCOL, METHYLPARABEN, DIAZOLIDINYL UREA, PROPYLPARABEN, COCAMIDOPROPYLAMINE OXIDE, ALLANTOIN, COCAMIDOPROPYL BETAINE, CETRIMONIUM CHLORIDE, TRIETHANOLAMINE, CITRIC ACID.

  • PRINCIPAL DISPLAY PANEL

    LABEL

  • INGREDIENTS AND APPEARANCE
    SOLDANIZER   DN-723
    benzalkonium chloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77015-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    COCAMIDOPROPYLAMINE OXIDE (UNII: M4SL82J7HK)  
    ALLANTOIN (UNII: 344S277G0Z)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77015-100-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product01/20/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/20/2021
    Labeler - 3VETS LLC (117147912)
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