Label: NUPERCAINAL- dibucaine ointment

  • 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 June 15, 2016

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Dibucaine 1%

  • Purpose

    Hemorrhoidal ointment

  • Use

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

    For external use only

    Allergy alert

    • certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, 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 within 7 days

    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. 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
  • Other information

    • store at 20-25°C (68-77°F)
  • Inactive ingredients

    acetone sodium bisulfite, lanolin, light mineral oil, purified water, white petrolatum

  • Questions?

    call 1-800-790-6417

  • PRINCIPAL DISPLAY PANEL - 56.7g Tube Box

    LONGEST LASTING
    INGREDIENT

    UP TO 8 HOURS

    NDC 55741-402-02

    NUPERCAINAL®
    HEMORRHOIDAL OINTMENT
    DIBUCAINE 1%

    Fast Temporary Relief of Pain, Itching,
    and Burning Due to Hemorrhoids.

    NET WT 2 oz. (56.7g)

    Principal Display Panel - 56.7g Tube Box
  • INGREDIENTS AND APPEARANCE
    NUPERCAINAL 
    dibucaine ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55741-402
    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)  
    light mineral oil (UNII: N6K5787QVP)  
    water (UNII: 059QF0KO0R)  
    petrolatum (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55741-402-021 in 1 BOX05/24/2016
    156.7 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34605/24/2016
    Labeler - Dr. Reddy's Laboratories Inc. (802315887)
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