Hemorrhoidex
Hamamelis Virginiana, Ratanhia
Nartex Laboratorios Homeopaticos, S.a. De C.v.
Human Otc Drug
NDC 34666-405Hemorrhoidex also known as Hamamelis Virginiana, Ratanhia is a human otc drug labeled by 'Nartex Laboratorios Homeopaticos, S.a. De C.v.'. National Drug Code (NDC) number for Hemorrhoidex is 34666-405. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Hemorrhoidex drug includes Hamamelis Virginiana Root Bark/stem Bark - 1 [hp_X]/64.9g Krameria Lappacea Root - 3 [hp_X]/64.9g . The currest status of Hemorrhoidex drug is Active.
Drug Information:
| Drug NDC: | 34666-405 |
| 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: | Hamamelis Virginiana, Ratanhia |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Nartex Laboratorios Homeopaticos, S.a. De C.v. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Gel |
| 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]/64.9g
KRAMERIA LAPPACEA ROOT - 3 [hp_X]/64.9g
|
| 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: | 30 Dec, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 22 Dec, 2025 |
| 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, S.A. de C.V.
|
| 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. |
| 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 |
|---|
| 34666-405-01 | 1 TUBE in 1 CARTON (34666-405-01) / 64.9 g in 1 TUBE | 30 Dec, 2021 | 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 each dose contains equal parts of: hamamelis virginiana 1x hpus*............hemorrhoids, pulsation in anus ratanhia 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.
Product Elements:
Hemorrhoidex hamamelis virginiana, ratanhia aloe vera leaf carbomer homopolymer, unspecified type glycerin hamamelis virginiana root bark/stem bark hamamelis virginiana root bark/stem bark propylparaben sodium methylparaben sodium water propylene glycol trolamine krameria lappacea root krameria lappacea root
Indications and Usage:
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:
Warnings for external use only. do not put 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. stop use and aska doctor if condition 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. 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 put 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. stop use and aska doctor if condition 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. 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.
Dosage and Administration:
Directions adults, cleanse the affected area with an appropriate cleaning wipe. apply generously to affected area up to 2 times daily. reapply if needed.
Stop Use:
Stop use and aska doctor if condition 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.
Package Label Principal Display Panel:
Ndc 34666-405-01 care hemorrhoidex gel hamamelis, ratanhia homeopathic hemorrhoid gel temporary soothing and cooling relief from burning, itching and relieves external discomfort. temporarily shrinks, swollen, hemorrhoidal tissue. cooling relief claims based on traditional homeopathic practice, not accepted medical evidence. not fda evaluated and not clinically tested. smooth gel formula with aloe homeopathic net wt. 2.29 oz (64.9 g) 1 2
Further Questions:
Questions or comments? informacion@nartex-labs.com or call 1-877-248-1970 between 9am and 5pm cst.