Label: HEMORRHOIDEX- ratanhia, hamamelis ointment

  • NDC Code(s): 34666-201-01
  • Packager: Nartex Laboratorios Homeopaticos SA DE CV
  • 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 February 28, 2022

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  • Active Ingredients

    Ratanhia........................3X HPUS

    Hamamelis....................1X HPUS

  • Purpose


    Ratanhia........................3X HPUS........Hemorrhoids, pain after stool, burning in anus

    Hamamelis....................1X HPUS.........Hemorrhoids, pulsation in rectum

    The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.  TINC is a homeopathic dilution: see www.nartexlabusa.com for details.
  • Uses

    Temporarily relieves discomforting symptoms such as itching, burning, and swelling associated with hemorrhoids. Product Uses are based on Homeopathic Materia Medica. 
    This product and its Uses have not been evaluated by the Food and Drug Administration.  This product has not been clinically tested by Nartex Labs USA, Inc.


  • Warnings

    For external use only

    Do not use

    • if you have an allergy or hypersensitivity to components of the formula or if you have had a prior reaction to this product

    Ask a doctor before use if you are

    •    under a doctor's care for any serious condition
    •    taking any other drug

    When using this product

    • avoid contact with the eyes.  If contact occurs, rinse eyes thoroughly with water
    • do not exceed the recommended daily dosage unless directed by physician

    Stop use and ask a doctor if

    • bleeding occurs
    • symptoms persist, worse, or if new symptoms occur after 7 days
    • rash develops

    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: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe.  Apply generously to affected area up to 2 times daily, especially at night, in the morning or after each bowel movement
    • reapply if needed
    • children under 12 years of age, consult a physician
  • Other Information

    • do not use if plastic seal around cap is broken or missing
    • store in a cool and dry place
  • Inactive Ingredients

    Glycerin, Glyceryl Monostearate, Lanolin, Purified Water, Talc USP, White petrolatum

  • Questions or comments?

    1-877-248-1970, between 9am and 5pm PT.
    informacion@nartexlabs.com

  • DESCRIPTION

    Distributed by:

    Nartex Labs USA, Inc.
    11711 Memorial dr #685
    Houston TX 77024
    www.nartexlabusa.com

  • Principal Display Panel

    HEMORRHOIDEX

    ointment

    Homeopathic Hemorrhoid Ointment



    Net Wt. 1.0 oz (28.35g)

    1

  • INGREDIENTS AND APPEARANCE
    HEMORRHOIDEX 
    ratanhia, hamamelis ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:34666-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    KRAMERIA LAPPACEA ROOT (UNII: P29ZH1A35Z) (KRAMERIA LAPPACEA ROOT - UNII:P29ZH1A35Z) KRAMERIA LAPPACEA ROOT3 [hp_X]  in 28.35 g
    HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS) HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK1 [hp_X]  in 28.35 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    LANOLIN (UNII: 7EV65EAW6H)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    TALC (UNII: 7SEV7J4R1U)  
    WATER (UNII: 059QF0KO0R)  
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:34666-201-011 in 1 CARTON04/17/2015
    128.35 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/17/2015
    Labeler - Nartex Laboratorios Homeopaticos SA DE CV (589914576)
    Registrant - Nartex Laboratorios Homeopaticos SA DE CV (589914576)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nartex Laboratorios Homeopaticos SA DE CV589914576manufacture(34666-201)
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