Label: DIBUCAINE ointment

  • NDC Code(s): 71399-2829-1, 71399-2829-2
  • Packager: Akron Pharma Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 12, 2025

If you are a consumer or patient please visit this version.

  • Drug Facts

    Active ingredient                        Purpose

    Dibucaine 1%                  Hemorrhoidal ointment

  • Uses

    temporanly relieves pain and nching due to hemorrhoids or other anorectal disorders

  • Warninigs

    For External Use Only

    Allergy alert

    • certain persons can develop allergic reactions to ingredients in this product. If the symptoms being treated does not subside or redness, irritation, swelling, bleeding or other symptoms develop or increase, discontinue use and ask a doctor.
  • Do not use

    • in children under 2 years at age
    • in or near the eyes
  • When using this product

    • avoid contact wnh eyes
    • do not use more than directed unless directed by a doctor
    • do not put this product into the rectum by using fingers or any mechanical device or applicator

    lf pregnant or breast feeding, ask a health care professional before use.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

    Stop use and ask a doctor if

    • bleeding occurs
    • condition worsens or does not improve wnhin 7 days
  • Directions

    • adults and children 12 years and over: if possible, clean the affected area with mild soap and wann water and nnse thoroughly. Dry by patting or blotting withh toilet tissue or a soft cloth before applying.
    • apply externally to the affected area up to 3 or 4 times daily
    • children under 12 years of age: ask a doctor
  • Inactive Ingredients

    Lanolin, Light Mineral Oil, Purified water, White Petrotalum

  • STORAGE AND HANDLING

    Store at room temperature 20o-25oC (68o-77oF)

  • Questions or Comments?

    call toll-free 1(877)225-6999

    Manufactured for
    Akron Pharma, Inc.,
    Fairfeld, NJ - 07004

  • PRINCIPAL DISPLAY PANEL

    1oz

    2oz

  • INGREDIENTS AND APPEARANCE
    DIBUCAINE 
    dibucaine ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71399-2829
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIBUCAINE (UNII: L6JW2TJG99) (DIBUCAINE - UNII:L6JW2TJG99) DIBUCAINE0.28 g  in 28 g
    Inactive Ingredients
    Ingredient NameStrength
    LANOLIN (UNII: 7EV65EAW6H)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    WATER (UNII: 059QF0KO0R)  
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71399-2829-128 g in 1 TUBE; Type 0: Not a Combination Product01/06/2025
    2NDC:71399-2829-21 in 1 PACKAGE01/06/2025
    256 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01501/06/2025
    Labeler - Akron Pharma Inc. (067878881)