Label: SOLDAMIST DN-420- 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

    Sanitizes to kills germs and helps reduce bacteria.

  • WARNINGS

    For external use only.

    Avoid usage if allergic to any of the ingredients.

    Stop using and consult a doctor if redness or irritation develops and persists for more than 72 hours.

  • KEEP OUT OF REACH OF CHILDREN

    Keep away from children. In case of accidental ingestion, seek medical help or contact a poison control center immediately (1-800-222-1222).

  • DIRECTIONS

    Spray sufficient amount of solution and allow to dry without wiping.

  • INACTIVE INGREDIENTS

    Water, Glycerine, Propylene Glycol, Rosemary Oil, Thyme Oil, Lemon Grass Oil.

  • PRINCIPAL DISPLAY PANEL

    01b LBL_Soldmist Hand Sanitizer_75mL

  • INGREDIENTS AND APPEARANCE
    SOLDAMIST   DN-420
    benzalkonium chloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77015-420
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    THYME OIL (UNII: 2UK410MY6B)  
    WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77015-420-1375 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)