Hemorrhoidex
Ratanhia, Hamamelis
Nartex Laboratorios Homeopaticos Sa De Cv
Human Otc Drug
NDC 34666-201Hemorrhoidex also known as Ratanhia, Hamamelis is a human otc drug labeled by 'Nartex Laboratorios Homeopaticos Sa De Cv'. National Drug Code (NDC) number for Hemorrhoidex is 34666-201. This drug is available in dosage form of Ointment. The names of the active, medicinal ingredients in Hemorrhoidex drug includes Hamamelis Virginiana Root Bark/stem Bark - 1 [hp_X]/28.35g Krameria Lappacea Root - 3 [hp_X]/28.35g . The currest status of Hemorrhoidex drug is Active.
Drug Information:
| Drug NDC: | 34666-201 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Hemorrhoidex |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Ratanhia, Hamamelis |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Nartex Laboratorios Homeopaticos Sa De Cv |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Ointment |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - 1 [hp_X]/28.35g
KRAMERIA LAPPACEA ROOT - 3 [hp_X]/28.35g
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | UNAPPROVED HOMEOPATHIC |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 17 Apr, 2015 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 09 May, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Nartex Laboratorios Homeopaticos SA DE CV
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0844827000399
|
| UPC stands for Universal Product Code. |
| UNII: | T7S323PKJS
P29ZH1A35Z
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 34666-201-01 | 1 TUBE in 1 CARTON (34666-201-01) / 28.35 g in 1 TUBE | 17 Apr, 2015 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
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.
Product Elements:
Hemorrhoidex ratanhia, hamamelis glycerin lanolin glyceryl monostearate talc water white petrolatum krameria lappacea root krameria lappacea root hamamelis virginiana root bark/stem bark hamamelis virginiana root bark/stem bark
Indications and Usage:
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:
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.
Do Not Use:
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.
When Using:
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
Dosage and Administration:
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
Stop Use:
Stop use and ask a doctor if bleeding occurs symptoms persist, worse, or if new symptoms occur after 7 days rash develops
Description:
Distributed by: nartex labs usa, inc. 11711 memorial dr #685 houston tx 77024 www.nartexlabusa.com
Package Label Principal Display Panel:
Principal display panel hemorrhoidex ointment homeopathic hemorrhoid ointment net wt. 1.0 oz (28.35g) 1
Further Questions:
Questions or comments? 1-877-248-1970, between 9am and 5pm pt. informacion@nartexlabs.com