Label: TRILOGEL- lidocaine hydrochloride gel

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

Drug Label Information

Updated June 24, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Lidocaine HCl, USP 2.8%

  • Purpose

    Topical analgesic

  • Uses

    For the temporary relief of pain associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations.

  • Warnings

    For external use only

    Do not use in large quantities, particularly over raw surfaces or blistered areas.

    When using this product avoid contact with eyes

    Stop use and ask a physician if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.

    If pregnant or breastfeeding, ask a health professional before use.

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

  • Directions

    • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
    • Children under 2 years of age: Do not use; consult a physician.
  • Other Information

    Store at 20-25°C (68-77°F). Protect from freezing.

  • Inactive Ingredients

    Caprylyl Glycol, Carica Papaya (Papaya) Fruit Extract, Disodium EDTA, Ethylhexylglycerin, Glycerin, Hexylene Glycol, Hydroxypropylcellulose, Phenoxyethanol, Purified Water, Sodium Lactate, Xanthan Gum.

  • Questions or Comments?

    (210) 944-6920

  • PRINCIPAL DISPLAY PANEL - 57 G Pouch Label

    Tear at notch to open. Do not use if seal is broken.

    NDC: 73352-620-01

    TRIFLUENT
    PHARMA™

    Trilogel™

    Lidocaine HCl 2.8%

    Topical Analgesic Gel

    For the temporary relief of pain associated with minor burns, sunburn,
    minor cuts, scrapes, insect bites, and minor skin irritations.

    NET WT. 2 OZ. (57 G)

    PRINCIPAL DISPLAY PANEL - 57 G Pouch Label
  • INGREDIENTS AND APPEARANCE
    TRILOGEL 
    lidocaine hydrochloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73352-620
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE28 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 9XZ8H6N6OH)  
    PAPAYA (UNII: KU94FIY6JB)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73352-620-011 in 1 POUCH06/24/2024
    157 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH DRUGM01706/24/2024
    Labeler - Trifluent Pharma LLC (117167281)
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