Label: DIBUCAINE- dibucaine 1% ointment

  • NDC Code(s): 63868-911-01
  • Packager: Chain Drug Marketing Association Inc.
  • 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 May 23, 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, bleeding 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 by patting or blotting with appropriate cleansing wipes or with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with a 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

  • Questions or Comments?

    Call Toll Free 1-800-935-2362

  • Other Information

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

  • Inactive Ingredients

    Lanolin, Light Mineral Oil, Purified Water, White Petrolatum

  • Distributed By

    Distributed by: CDMA, Inc.

    Novi, MI 48375 USA

    1-800-935-2362

    * This product is not manufactured or distributed by Ducere Pharma, Distributor of Nuper-Cainal

  • Packaging

    qc-dibucaine-1oz-CDER 2

  • INGREDIENTS AND APPEARANCE
    DIBUCAINE 
    dibucaine 1% ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-911
    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
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    WATER (UNII: 059QF0KO0R)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    LANOLIN (UNII: 7EV65EAW6H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-911-011 in 1 BOX09/14/2022
    128.3 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34609/14/2022
    Labeler - Chain Drug Marketing Association Inc. (011920774)
    Registrant - Trifecta Pharmaceuticals USA LLC. (079424163)
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