Label: DIBUCAINE ointment

  • NDC Code(s): 45802-050-03
  • Packager: Padagis Israel Pharmaceuticals Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 November 10, 2021

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  • Active ingredient

    Dibucaine 1%

  • Purpose

    Hemorrhoidal/topical analgesic

  • Uses

    for hemorrhoidal:

    •
    for the temporary relief of pain, itching and burning due to hemorrhoids and other anorectal disorders for topical analgesic:
    •
    for the temporary relief of pain and itching caused by sunburn, minor burns, minor cuts, scrapes, insect bites or minor skin irritation
  • Warnings

    For external use only

    Allergy warning: Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and ask a doctor.

    Do not use

    •
    in or near the eyes
    •
    in infants under 2 years of age or weighing less than 35 pounds

    When using this product

    for hemorrhoidal:

    •
    do not exceed the recommended daily dosage unless directed by a doctor
    •
    do not put this product into the rectum by using fingers or any mechanical device or applicator

    for topical analgesic:

    •
    do not use in large quantities, particularly over raw surfaces or blistered areas

    Stop use and ask a doctor if

    for hemorrhoidal:

    •
    condition worsens or does not improve within 7 days
    •
    bleeding occurs

    for topical analgesic:

    •
    condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

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

  • Directions

    for hemorrhoidal:

    •
    adults and children 12 years & older: when practical, clean the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with 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

    for topical analgesic:

    •
    adults and children 2 years of age and over: apply to affected area not more than 3 to 4 times daily
    •
    children under 2 years of age: ask a doctor
  • Other information

    store at 20°-25°C (68°-77°F)

  • Inactive ingredients

    acetone sodium bisulfite, lanolin, white petrolatum

  • Questions or comments?

    1-800-719-9260

  • Package/Label Principal Display Panel

    Child Resistant Packaging

    Temporary Relief of Local Discomfort, Burning and Itching Associated with Inflamed Hemorrhoidal Tissues

    Compare to Nupercainal® active ingredient

    Dibucaine Ointment 1%

    Hemorrhoidal & Topical Analgesic

    NET WT 1 OZ (28 g)

    Perrigo Dibucaine Ointment
  • INGREDIENTS AND APPEARANCE
    DIBUCAINE 
    dibucaine ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45802-050
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45802-050-031 in 1 CARTON06/20/2011
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34606/20/2011
    Labeler - Padagis Israel Pharmaceuticals Ltd (600093611)
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