Label: TETRACAINE gel

  • 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 December 20, 2017

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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
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SORBIC ACID (UNII: X045WJ989B)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    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 not finalpart34806/01/2017
    Labeler - Bellus Medical, LLC (005677967)
    Registrant - Bellus Medical, LLC (005677967)
    Establishment
    NameAddressID/FEIBusiness Operations
    Filltech USA, LLC965596435manufacture(71888-103)
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