Label: DIBUCAINE- dibucaine 1% ointment

  • NDC Code(s): 57896-131-01
  • Packager: Geri-Care Pharmaceuticals, Corp
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 20, 2023

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  • Drug Facts

  • Active Ingredient

    Dibucaine 1%

  • PURPOSE

    Hemorrhoidal Ointment

  • INDICATIONS & USAGE

    Temporarily relieves pain and itching due to hemorrhoids or other anorectal disorders.

  • If Pregnant or Breast-Feeding

    Ask a health care professional before use.

  • Stop Use and ask a doctor

    • Bleeding occurs
    • Condition worsens or does not improve within 7 days

  • Keep out of the reach of Children

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

  • Do Not Use

    In or near eyes

    In children under 2 years of age

  • Warnings

    For External use only

    Allergy alert

    Certain persons can develop allergic reactions to ingredients in this product.

    If the symptoms being treated do not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and ask a doctor.

  • 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.

  • Directions

    • Adults and children 12 years of age or older. If possible, clean the affected area with mild soap and warm water and rinse thoroughly. Dry by patting or blotting 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 20º-25ºC (68º-77ºF)

    Tamper-evident; do not use if foil seal is broken or missing

  • Inactive Ingredients

    Lanolin, Light Mineral Oil, Purified Water, White Petrolatum

  • Distributed By

    Geri-Care Pharmaceuticals Corp.

    1650 63rd Street

    Brooklyn, NY 11204

    1-800-540-3765

    Product of China

    * This product is not manufactured or distributed by the owner of the registered trademark Nupercainal®

  • Packaging

    gericare-dibucaine-1oz-CDER

  • INGREDIENTS AND APPEARANCE
    DIBUCAINE 
    dibucaine 1% ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57896-131
    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
    WATER (UNII: 059QF0KO0R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    LANOLIN (UNII: 7EV65EAW6H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57896-131-011 in 1 BOX09/22/2020
    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 DrugM01709/22/2020
    Labeler - Geri-Care Pharmaceuticals, Corp (611196254)
    Registrant - Trifecta Pharmaceuticals USA LLC. (079424163)
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