Label: DIBUCAINE ointment

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated July 25, 2012

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  • Active Ingredient:

    Dibucaine 1%

  • Purpose:

    Topical Anesthetic

  • INDICATIONS & USAGE

    Uses:

    • for temporary relief of pain and itching associated with:
    • sunburn
    • minor burns
    • hemorrhoids
    • cuts
    • scratches
    • insect bites
    • stings
  • WARNINGS

    Warnings:

    For external use only

    Do not use in the eyes

    Stop use and ask a doctor if

    • the condition persists or if rash or irritation develops
    • you have rectal bleeding
  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions:

    • not for prolonged use
    • adults should not use more than the tube in 24 hours or 1/4 tube for child
    • apply to affected area 3 or 4 times daily
    • cover with light dressing, if necessary
  • SPL UNCLASSIFIED SECTION

    Other information:

    • store at room temperature.
    • see crimp of tube for Lot Number and Expiration Date.
  • Inactive Ingredients

    acetone sodium bisulfite 1/2% as a preservative, lanolin, purified water, white petrolatum

  • SPL UNCLASSIFIED SECTION

    Questions or comments? call toll free 1-800-645-9833

    E. FOUGERA & CO.

    A division of Fougera Pharmaceuticals Inc.

    Melville, NY 11747

    C4905B

    R12/11

  • PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER

    Fougera®

    NDC 0168-0046-31

    CHILD-RESISTANT PACKAGE

    DIBUCAINE OINTMENT USP, 1%

    TOPICAL ANESTHETIC

    NET WT 28.35g (1 Oz)

    FOR EXTERNAL USE ONLY

    DO NOT USE IN THE EYES

    PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – LABEL
  • PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CARTON

    NDC 0168-0046-31

    Fougera®

    DIBUCAINE OINTMENT USP, 1%

    TOPICAL ANESTHETIC

    NET WT 28.35g (1 Oz)

    Laminate Tube with Child-Resistant Cap

    FOR EXTERNAL USE ONLY

    DO NOT USE IN THE EYES

    PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CARTON
  • INGREDIENTS AND APPEARANCE
    DIBUCAINE 
    dibucaine ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0168-0046
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIBUCAINE (UNII: L6JW2TJG99) (DIBUCAINE - UNII:L6JW2TJG99) DIBUCAINE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ACETONE SODIUM BISULFITE (UNII: 47VY054OXY)  
    LANOLIN (UNII: 7EV65EAW6H)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0168-0046-311 in 1 CARTON
    128 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34601/01/1968
    Labeler - E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. (043838424)
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