NDC 34666-291 Hemorrhoid-x Treatment Pack

Hemorrhoid-x Treatment Pack

NDC Product Code 34666-291

NDC Code: 34666-291

Proprietary Name: Hemorrhoid-x Treatment Pack What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Hemorrhoid-x Treatment Pack What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 34666 - Nartex Laboratorios Homeopaticos Sa De Cv
    • 34666-291 - Hemorrhoid-x Treatment Pack

NDC 34666-291-01

Package Description: 1 KIT in 1 KIT * 1 TABLET in 1 BOX

NDC Product Information

Hemorrhoid-x Treatment Pack with NDC 34666-291 is a a human over the counter drug product labeled by Nartex Laboratorios Homeopaticos Sa De Cv. The generic name of Hemorrhoid-x Treatment Pack is hemorrhoid-x treatment pack. The product's dosage form is kit and is administered via oral; topical form.

Labeler Name: Nartex Laboratorios Homeopaticos Sa De Cv

Dosage Form: Kit - A packaged collection of related material.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)
  • STARCH, POTATO (UNII: 8I089SAH3T)
  • TALC (UNII: 7SEV7J4R1U)
  • GELATIN (UNII: 2G86QN327L)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • WATER (UNII: 059QF0KO0R)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • TALC (UNII: 7SEV7J4R1U)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • LANOLIN (UNII: 7EV65EAW6H)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Nartex Laboratorios Homeopaticos Sa De Cv
Labeler Code: 34666
Marketing Category: UNAPPROVED HOMEOPATHIC - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 04-11-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Hemorrhoid-x Treatment Pack Product Label Images

Hemorrhoid-x Treatment Pack Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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 anusCollinsonia 6C HPUS*.........Hemorrhoids, itching or burning in anus with swellingHamamelis 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.

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

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.

Otc - Ask Doctor

  • Ask a doctor before use if you are under a doctor's care for any serious conditiontaking any other drug

Ask a doctor before use if you areunder a doctor's care for any serious condition

taking any other drug

Otc - Stop Use

  • Stop use and ask a doctor ifSymptoms persist, worsen, or if new symptoms occur after 7 daysrash develops

  • Stop use and ask a doctor ifbleeding occurssymptoms persist, worsen, or if new symtoms occur after 7 daysrash develops

Otc - When Using

  • When using this productdo not exceed recommended daily dosage unless directed by a physcian.

  • When using this productavoid contact with eyes. If contact occurs, rinse eyes thoroughly with waterdo not exceed the recommended daily dosage unless directed by physiciando not put into the rectum by use of fingers or any mechanical device or applicator

Otc - Pregnancy Or Breast Feeding

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

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

Otc - 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.

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 hoursChildren under 12 years of age: consult a physician

  • 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 neededChildren under 12 years of age, consult a phsyician.

Other Information

Store in a cool and dry place.

  • Do not use if tube seal is broken or missingstore in a cool and dry placethere 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

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

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

Other

Product of Mexico / Producto de MexicoDistributed by:
Nartex Labs, USA, Inc.11711 Memorial Drive #685Houston, TX 77024www.nartexlabsusa.com

Active Ingredients

Ratanhia 3X HPUS*Hamamelis 1X HPUS*

Warnings

For external use only.

Otc - Do Not Use

  • Do not useif you have an allergy or hypersensitivity to the components of the fourmal or have had a prior reaction to this product.

* Please review the disclaimer below.

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