Label: NUPERCAINAL BIO-ACTIVE HEMORRHOIDAL- hamamelis virginiana root bark/stem bark, echinacea purpurea, centella asiatica, and sambucus nigra flowering top cream

  • 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 18, 2014

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Hamamelis virginiana 2x
    Proprietary herbal blend 2x:

    -
    Echinacea purpurea
    -
    Centella asiatica
    -
    Sambucus nigra
  • Purpose

    relief of external hemorrhoids

  • Use

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

    For external use only

    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 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 6 times daily
    • children under 12 years of age: ask a doctor
  • Other information

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

    petrolatum, PEG-40 hydrogenated castrol oil, propylene glycol, beeswax, paraffin, lanolin, olive oil, titanium dioxide, phenoxy ethanol, menthol, aloe vera, dmdm hydantoin

  • 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 - 56.7 g Tube Carton

    Herbal Formula

    NDC 55741-412-02

    NUPERCAINAL®
    Bio-Active    ™
    HEMORRHOIDAL CREAM

    Relieves Pain, Itching & Burning of External Hemorrhoids

    ✓ Fast Acting Relief ✓ Soothing Herbal Cream

    HOMEOPATHIC

    NET WT 2 oz (56.7g)

    Principal Display Panel - 56.7 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    NUPERCAINAL BIO-ACTIVE HEMORRHOIDAL 
    hamamelis virginiana root bark/stem bark, echinacea purpurea, centella asiatica, and sambucus nigra flowering top cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55741-412
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Hamamelis Virginiana Root Bark/Stem Bark (UNII: T7S323PKJS) (Hamamelis virginiana root bark/stem bark - UNII:T7S323PKJS) Hamamelis Virginiana Root Bark/Stem Bark5 g  in 100 g
    Echinacea purpurea (UNII: QI7G114Y98) (Echinacea purpurea - UNII:QI7G114Y98) Echinacea purpurea5 g  in 100 g
    Centella asiatica (UNII: 7M867G6T1U) (Centella asiatica - UNII:7M867G6T1U) Centella asiatica5 g  in 100 g
    Sambucus Nigra Flowering Top (UNII: CT03BSA18U) (Sambucus nigra flowering top - UNII:CT03BSA18U) Sambucus Nigra Flowering Top5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    petrolatum (UNII: 4T6H12BN9U)  
    Polyoxyl 40 Hydrogenated Castor Oil (UNII: 7YC686GQ8F)  
    propylene glycol (UNII: 6DC9Q167V3)  
    yellow wax (UNII: 2ZA36H0S2V)  
    paraffin (UNII: I9O0E3H2ZE)  
    lanolin (UNII: 7EV65EAW6H)  
    olive oil (UNII: 6UYK2W1W1E)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    menthol (UNII: L7T10EIP3A)  
    aloe vera leaf (UNII: ZY81Z83H0X)  
    dmdm hydantoin (UNII: BYR0546TOW)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55741-412-021 in 1 CARTON
    156.7 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED HOMEOPATHIC04/07/2014
    Labeler - Ducere Pharma (078715029)
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