Label: TETRACAINE gel

  • NDC Code(s): 71888-103-01, 71888-103-02
  • Packager: Bellus Medical, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 8, 2023

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  • ACTIVE INGREDIENT

    Tetracaine HCL 2%

  • INACTIVE INGREDIENT

    Water, Glycerin, Propylene Glycol, Hydroxyethyl Cellulose, Phenoxyethanol, Caprylyl Glycol, Aloe Barbadensis (Aloe Vera) Leaf Extract, Sorbic Acid, Tetrasodium EDTA

  • DOSAGE & ADMINISTRATION

    Uses : For the temporary relief of discomfort and pain associated with

    • Minor burns and skin irritations
    • Minor cuts and scrapes
    • Itching

    Directions : Adults and Children 12 years of age and older Apply to affected area not more than 3-4 times daily.

  • WARNINGS

    Warnings : For external use only. Avoid contact with the eyes.

    DO NOT USE : In large quantities, particularly over raw surfaces and blistered areas.

    Stop use and ask a doctor if:

    • Skin becomes irritated
    • Condition worsens or symptoms last more than 7 days
    • Symptoms clear up and reoccur within a few days.
  • PURPOSE

    Topical Anesthetic

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • INDICATIONS & USAGE

    Uses : For the temporary relief of discomfort and pain associated with

    • Minor burns and skin irritations
    • Minor cuts and scrapes
    • Itching

    Directions : Adults and Children 12 years of age and older Apply to affected area not more than 3-4 times daily.

  • PRINCIPAL DISPLAY PANEL

    BLT_4ml_Packet_T_170613 JPEG

  • INGREDIENTS AND APPEARANCE
    TETRACAINE 
    tetracaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71888-103
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TETRACAINE HYDROCHLORIDE (UNII: 5NF5D4OPCI) (TETRACAINE - UNII:0619F35CGV) TETRACAINE HYDROCHLORIDE20 mg  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SORBIC ACID (UNII: X045WJ989B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71888-103-0212 in 1 BOX06/01/2017
    1NDC:71888-103-014 mL in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01706/01/2017
    Labeler - Bellus Medical, LLC (005677967)
    Registrant - Bellus Medical, LLC (005677967)
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