Label: DIBUCAINE- dibucaine 1% ointment

  • NDC Code(s): 69396-023-01
  • Packager: Trifecta Pharmaceuticals USA LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 2, 2024

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

View All Sections
  • 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 platting or blotting with an appropriate cleansing wipe, 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 1-888-296-9067

  • Other Information

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

  • Inactive Ingredients

    Lanolin, Light Mineral Oil, Purified Water, White Petrolatum

  • Distributed By

    Trifecta Pharmaceuticals USA

    101 NE Third Avenue, Suite 1500

    Ft. Lauderdale, FL. 33301 USA

    1-888-296-9067

    Made in China

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

    Child Resistant Packaging

  • Packaging

    globe-dibucaine-1oz-CDER

  • INGREDIENTS AND APPEARANCE
    DIBUCAINE 
    dibucaine 1% ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-023
    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
    PETROLATUM (UNII: 4T6H12BN9U)  
    WATER (UNII: 059QF0KO0R)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    LANOLIN (UNII: 7EV65EAW6H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69396-023-011 in 1 BOX09/14/2022
    128.4 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01709/14/2022
    Labeler - Trifecta Pharmaceuticals USA LLC (079424163)
    Registrant - Trifecta Pharmaceuticals USA LLC. (079424163)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!