NDC 34666-405 Hemorrhoidex

Hamamelis Virginiana, Ratanhia

NDC Product Code 34666-405

NDC 34666-405-01

Package Description: 1 TUBE in 1 CARTON > 64.9 g in 1 TUBE

NDC Product Information

Hemorrhoidex with NDC 34666-405 is a a human over the counter drug product labeled by Nartex Laboratorios Homeopaticos, S.a. De C.v.. The generic name of Hemorrhoidex is hamamelis virginiana, ratanhia. The product's dosage form is gel and is administered via topical form.

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

Hemorrhoidex Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.


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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)
  • METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)
  • WATER (UNII: 059QF0KO0R)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • TROLAMINE (UNII: 9O3K93S3TK)

Administration Route(s)

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

  • 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, S.a. De C.v.
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: 12-30-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Hemorrhoidex 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 Ingredients

Each dose contains equal parts of:Hamamelis virginiana 1X HPUS*Ratanhia 3X HPUS**The letters "HPUS" indciate that the components in the product are officially monographed in the Homeopathic Pharmacopoeia of the United States. "X" is an homeopathic dilution. See www.nartexlabsusa.com for more information.

Purpose

Each dose contains equal parts of:Hamamelis virginiana 1X HPUS*............Hemorrhoids, pulsation in anusRatanhia 3X HPUS*....................Hemorrhoids, pain after stool, burning in anus*The letters "HPUS" indciate that the components in the product are officially monographed in the Homeopathic Pharmacopoeia of the United States. "X" is an homeopathic dilution. See www.nartexlabsusa.com for more information.

Uses

Temporary soothing and cooling relief of external hemorrhoid symptoms such as itching, burning and relieves external discomfort. Temporary relief of shrinks, swollen, hemorrhoidal tissue.Claims based on traditional homeopathic practice, not accepted medical evidence. These uses have not been evaluated by FDA, and product has not been clincially tested.

Warnings

For external use only.

Otc - Do Not Use

  • Do notput this product into rectum by using fingers or any mechanical device or applicator.use if you have an allergy or hypersenstivity to components of the formula or if you have had a prior reaction to this.

Otc - Stop Use

  • Stop use and aska doctor ifcondition worsens.does not improve within 7 days.rash develops.do not exceed the recommended daily dosage unless directed by a doctor.in case of bleeding, consult a doctor promptly.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast feeding, ask 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.

Directions

  • Adults, cleanse the affected area with an appropriate cleaning wipe.apply generously to affected area up to 2 times daily.reapply if needed.

Other Information

  • Store at room temperaturedo not use if tube seal is broken or missingfor external use only

Inactive Ingredients

Aloe vera leaf powder, Carbomer, Glycerin, Methylparaben sodium, Propylene glycol, Propylparaben sodium, Purified water, Triethanolamine.

* Please review the disclaimer below.