Label: NUPERCAINAL BIO-ACTIVE HEMORRHOIDAL- echinacea purpurea, centella asiatica, and sambucus nigra flowering top suppository

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated April 25, 2014

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Proprietary herbal blend 2x:
        - Echinacea purpurea
        - Centella asiatica
        - Sambucus nigra

  • Purpose

    relief of internal hemorrhoids

  • Use

    • helps relieve the local itching and discomfort associated with hemorrhoids
    • temporarily relieves burning and shrinks hemorrhoidal tissue
    • temporarily provides a coating for relief of anorectal discomforts
    • temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful
  • Warnings

    For rectal use only

    When using this product do not exceed the recommended daily dosage unless directed by a doctor.

    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: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe
    • gently dry by patting or blotting with a tissue or a soft cloth before insertion of this product
    • detach one suppository from the strip; remove the wrapper before inserting into the rectum as follows:
      • hold suppository with rounded end up
      • as shown, carefully separate tabs by inserting tip of fingernail at end marked "peel down"
      • slowly and evenly peel apart (do not tear) by pulling tabs down both sides, to expose the suppository
      • remove exposed suppository from wrapper
      • insert one suppository into rectum up to 4 times daily, especially at night, in the morning or after each bowel movement
    • children under 12 years of age: ask a doctor
  • Other information

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

    hydrogenated cocoglyceride base, cocoa butter, propylene glycol

  • Questions?

    call 1-800-790-6417 Monday thru Friday 8am-5pm EST

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Ducere Pharma • Somerville, NJ 08876 USA

  • PRINCIPAL DISPLAY PANEL - 24 Suppository Carton

    NDC 55741-424-24

    Herbal Formula

    NUPERCAINAL®
    Bio-Active
    HEMORRHOIDAL SUPPOSITORIES

    Relieves Pain, Itching & Burning
    of Internal Hemorrhoids

    Shrinks Internal Swollen
    Hemorrhoidal Tissue
    Soothing Herbal Formula

    HOMEOPATHIC
    24
    SUPPOSITORIES

    PRINCIPAL DISPLAY PANEL - 24 Suppository Carton
  • INGREDIENTS AND APPEARANCE
    NUPERCAINAL BIO-ACTIVE HEMORRHOIDAL 
    echinacea purpurea, centella asiatica, and sambucus nigra flowering top suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55741-424
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Echinacea purpurea (UNII: QI7G114Y98) (Echinacea purpurea - UNII:QI7G114Y98) Echinacea purpurea0.1 g
    Centella asiatica (UNII: 7M867G6T1U) (Centella asiatica - UNII:7M867G6T1U) Centella asiatica0.1 g
    Sambucus nigra flowering top (UNII: CT03BSA18U) (Sambucus nigra flowering top - UNII:CT03BSA18U) Sambucus nigra flowering top0.1 g
    Inactive Ingredients
    Ingredient NameStrength
    hydrogenated coco-glycerides (UNII: XDD37N2GPR)  
    cocoa butter (UNII: 512OYT1CRR)  
    propylene glycol (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55741-424-244 in 1 CARTON
    16 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC04/07/2014
    Labeler - Ducere Pharma (078715029)