Label: HEMORRHOID-X TREATMENT PACK kit

  • NDC Code(s): 34666-291-01
  • Packager: Nartex Laboratorios Homeopaticos SA DE CV
  • Category: HUMAN OTC DRUG LABEL

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 12, 2019

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Hemorrhoid-x Treatment Pack - Hemorrhoidex Tablets

  • Drug Facts

  • Active Ingredient (in each tablet)

    Aesculus Hipp 6C HPUS*

    Collinsonia 6C HPUS*

    Hamamelis 6C HPUS*

  • Purpose

    Aesculus Hipp 6C HPUS*.........Hemorrhoids, pain after stool, aching, swollen, burning in anus

    Collinsonia 6C HPUS*.........Hemorrhoids, itching or burning in anus with swelling

    Hamamelis 6C 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. "C" is an homeopathic dilution. See www.nartexlabsusa.com formore information.

  • Uses

    Temporarily relieves discomforting symptoms such as itching, burning, and swelling associated with hemorrhoids. Product claims and Uses are based on Homeopathic Materia Medica not clinical test. 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

  • ASK DOCTOR

    Ask a doctor before use if you are

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

    Stop use and ask a doctor if

    • Symptoms persist, worsen, or if new symptoms occur after 7 days
    • rash develops
  • WHEN USING

    When using this product

    • do not exceed recommended daily dosage unless directed by a physcian.
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Adults and childrenover 12 years: take 2 tablets every 6 hours
    • Children under 12 years of age: consult a physician
  • Other Information

    Store in a cool and dry place.

  • Inactive Ingredients

    Gelatin, Lactose, Magnesium stearate, Potato stach, Sodium Benzoate, Talc

  • Questions or Comments?

    Call 1-877-248-1970 between 9am and 5pm PT.

    Informacion@nartexlabs.com

  • SPL UNCLASSIFIED SECTION

    Product of Mexico / Producto de Mexico

    Distributed by: Nartex Labs, USA, Inc.

    11711 Memorial Drive #685

    Houston, TX 77024

    www.nartexlabsusa.com

  • Hemorrhoid-x Treatment Pack - Hemorrhoidex ointment

  • Drug Facts

  • 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 offically monographed in the Homeopathic Pharmacopoeia of the United States. X is an homeopathic dilution: see www.nartexlabsusa.com for more information.

  • Uses

    Temporarily relieves discomforting symptoms such as itching, burning, and swelling associated with hemorrhoids. Product claims and Uses are based on Homeopathic Materia Medica not clinical test. 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. This product has not been shown to relieve symptoms such as itching, burning, and swelling associated with hemorrhoids.

  • Warnings

    For external use only.

  • DO NOT USE

    Do not use

    • if you have an allergy or hypersensitivity to the components of the fourmal or have had a prior reaction to this product.
  • ASK DOCTOR

    Ask a doctor before use if you are

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

  • WHEN USING

    When using this product

    • avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water
    • do not exceed the recommended daily dosage unless directed by physician
    • do not put into the rectum by use of fingers or any mechanical device or applicator
  • STOP USE

    Stop use and ask a doctor if

    • bleeding occurs
    • symptoms persist, worsen, or if new symtoms occur after 7 days
    • rash develops
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast feeding, consult a health professional before use,

  • KEEP OUT OF REACH OF CHILDREN

    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 phsyician.
  • Other Information

    • do not use if tube seal is broken or missing
    • store in a cool and dry place
    • there is no scientific evidence that the product works. Product claims are based only on theories of homeopathy from the 1700's that are not accepted by most modern medical experts.
  • Inactive Ingredients

    Glycerin, Glyceryl monostearate, Lanolin, Purifed water, Talc, White petrolatum

  • Questions or Comments?

    1-877-248-1970 between 9am and 5pm CST.

    informacion@nartexlabs.com

  • Principal Display Panel

    TREATMENT PACK

    HOMEOPATHIC

    HEMORRHOID-X

    Temporarily relieves discomforting symptoms such as itching, burning, and swelling associated with

    Hemorroids

    COMBO pack

    There is no scientific evidence that the product works. Product's claims are based only on theories of homeopathy from the 1700's that are not accepted by most modern medical experts.

    Contains

    1 tube Net. Wt. 1.0oz (28.35g) and 1 box 30 tablets.

    Hemorrhoid-x Twin Pack

  • INGREDIENTS AND APPEARANCE
    HEMORRHOID-X TREATMENT PACK 
    hemorrhoid-x treatment pack kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:34666-291
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:34666-291-011 in 1 KIT; Type 1: Convenience Kit of Co-Package04/11/2019
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 130 BOX 30 
    Part 2 2   in 2 
    Part 1 of 2
    HEMORRHOIDEX 
    hemorrhoidex tablet
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    COLLINSONIA CANADENSIS WHOLE (UNII: IOS9HV04K7) (COLLINSONIA CANADENSIS WHOLE - UNII:IOS9HV04K7) COLLINSONIA CANADENSIS WHOLE6 [hp_C]
    AESCULUS HIPPOCASTANUM WHOLE (UNII: 2331W47PSX) (AESCULUS HIPPOCASTANUM WHOLE - UNII:2331W47PSX) AESCULUS HIPPOCASTANUM WHOLE6 [hp_C]
    HAMAMELIS VIRGINIANA WHOLE (UNII: V663Q8TEFU) (HAMAMELIS VIRGINIANA WHOLE - UNII:V663Q8TEFU) HAMAMELIS VIRGINIANA WHOLE6 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    STARCH, POTATO (UNII: 8I089SAH3T)  
    TALC (UNII: 7SEV7J4R1U)  
    GELATIN (UNII: 2G86QN327L)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    Colorwhite (white) Scorescore with uneven pieces
    ShapeROUND ((tablet)) Size10mm
    FlavorImprint Code none
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    11 in 1 BOX; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/11/2019
    Part 2 of 2
    HEMORRHOIDE-X 
    hemorrhoide-x ointment
    Product Information
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    KRAMERIA LAPPACEA WHOLE (UNII: 97AC37R8BM) (KRAMERIA LAPPACEA WHOLE - UNII:97AC37R8BM) KRAMERIA LAPPACEA WHOLE3 [hp_X]  in 1 g
    HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV) (HAMAMELIS VIRGINIANA LEAF - UNII:T07U1161SV) HAMAMELIS VIRGINIANA LEAF1 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TALC (UNII: 7SEV7J4R1U)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    LANOLIN (UNII: 7EV65EAW6H)  
    Product Characteristics
    ColorwhiteScore    
    ShapeFREEFORMSize
    FlavorImprint Code
    Contains    
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/11/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/11/2019
    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(34666-291)