Label: DIBUCAINE TOPICAL ANESTHETIC 1% HEMORRHOIDAL- dibucaine ointment

  • NDC Code(s): 0536-1211-95
  • Packager: Rugby Laboratories Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 24, 2023

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  • ​Drug Facts

  • ​Active ingredient

    Dibucaine 1%

    ​Purpose

    Hemmorhoidal ointment

  • ​Use

    • temporarily relieves pain and itching due to hemorrhoids and other anorectal disorders
  • ​Warnings

    ​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 if redness, irritaion, swelling, bleeding or other symptoms develop or increase, discontinue use and ask a doctor.

    Do not use

    • in or near the eyes
    • in children under 2 years of age

    When using this product

    • 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

    Stop use and ask a doctor if

    • bleeding occurs
    • condition worsens or does not improve

    If 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.

  • ​Directions

    • adults and children 12 years and over:  If possible, clean the affected area with mild soap and warm water and rinse thoroughly. Dry by patting or with toilet tissue or a soft cloth before applying.
    • apply externally to the affected area up to 3 to 4 times daily.
    • children under 12 years of age:  ask a doctor
  • ​Other information

    • Store at 20-25 ​C (68-77 ​F) ​o​o
    • tamper-evident:  do not use if foil seal is broken or missing
  • undefined

    Lanolin, Light Mineral Oil, Purified Water, White Petrolatum

  • Questions or comments?

    call 1-800-645-2158

  • Package Labeling:

    Package 1 OZ

  • INGREDIENTS AND APPEARANCE
    DIBUCAINE TOPICAL ANESTHETIC 1% HEMORRHOIDAL 
    dibucaine ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1211
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIBUCAINE (UNII: L6JW2TJG99) (DIBUCAINE - UNII:L6JW2TJG99) DIBUCAINE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    LANOLIN (UNII: 7EV65EAW6H)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    WATER (UNII: 059QF0KO0R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0536-1211-951 in 1 BOX08/19/2019
    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 DrugM01508/19/2019
    Labeler - Rugby Laboratories Inc. (079246066)
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