Label: TRIDERGEL- benzalkonium chloride gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 8, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Benzalkonium Chloride (0.1%)

  • Purpose

    Antimicrobial

  • INDICATIONS & USAGE

    Indications for management of:

    • Stage 1-2 open wounds
    • Superficial stasis ulcers
    • Superficial diabetic skin ulcers
    • Post-surgical incisions
    • First and second-degree burns
    • Cuts
    • Abrasions and skin irritations
  • Warnings

    For external use only.

    When using this product avoid contact with eyes; rinse immediately with cool tap water if contact occurs.

    Do not use more than the recommended dose or longer than prescribed without checking with your physician. Talk with your physician before you use any other medicines or cleansers on your skin. Ask your physician before prolonged sun exposure. If your symptoms do not improve or they worsen, contact your physician

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

  • Directions

    • Clean the wound before each application
    • Apply a thin layer of Tridergel™ wound care gel to the wound surface and skin immediately surrounding the wound
    • Cover the wound as directed by your physician
  • Inactive Ingredients

    Aloe Barbadensis Leaf Juice Extract, Aminomethyl Propanol, Butylparaben, Carbomer, Decyl Glucoside, Ethylparaben, Glycerin, Hydrolyzed Eggshell Membrane, Isobutylparaben, Methylparaben, Phenoxyethanol, Propylparaben, Purified Water, Sodium Hyaluronate.

  • QUESTIONS OR COMMENTS

    CALL (210) 944-6920

  • PRINCIPAL DISPLAY PANEL - 29.6 mL Bottle Label

    TRIFLUENT
    PHARMA®

    TRIDERGEL™
    WOUND CARE GEL

    BENZALKONIUM CHLORIDE

    IN A GEL CONTAINING
    TRANSFORMING GROWTH
    FACTOR – β

    NDC 73352-520-01

    1.0 FL OZ (29.6 mL)

    PRODUCT SHOULD BE ADMINISTERED
    UNDER THE SUPERVISION OF A
    LICENSED MEDICAL PRACTITIONER

    PRINCIPAL DISPLAY PANEL - 29.6 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    TRIDERGEL 
    benzalkonium chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73352-520
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.001 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    EGG SHELL MEMBRANE (UNII: N7QBR4212V)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73352-520-0129.6 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product12/11/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM00512/11/2023
    Labeler - Trifluent Pharma LLC (117167281)
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