Gy-na-tren
Boric Acid, Marigold, Coneflower, Arborvitae, Borate Of Sodium, Beechwood Kreosote, Wind Flower, Lactobacillus Acidophilus, Vitamin C
Natren Inc.
Human Otc Drug
NDC 32267-940Gy-na-tren also known as Boric Acid, Marigold, Coneflower, Arborvitae, Borate Of Sodium, Beechwood Kreosote, Wind Flower, Lactobacillus Acidophilus, Vitamin C is a human otc drug labeled by 'Natren Inc.'. National Drug Code (NDC) number for Gy-na-tren is 32267-940. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Gy-na-tren drug includes . The currest status of Gy-na-tren drug is Active.
Drug Information:
| Drug NDC: | 32267-940 |
| 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: | Gy-na-tren |
| 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: | Boric Acid, Marigold, Coneflower, Arborvitae, Borate Of Sodium, Beechwood Kreosote, Wind Flower, Lactobacillus Acidophilus, Vitamin C |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Natren Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Kit |
| 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: | |
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | |
| 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: | 02 May, 2016 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 05 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: | Natren Inc.
|
| 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: | |
| 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 |
|---|
| 32267-940-14 | 1 KIT in 1 CARTON (32267-940-14) * 14 SUPPOSITORY in 1 PACKAGE (32267-941-14) | 02 May, 2016 | 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:
Boricum acidum 3x 120 mg hpus (boric acid) calendula officinalis 1x 120 mg hpus (marigold) echinacea angustifolia 1x 120 mg hpus (coneflower) thuja occidentalis 1x 120 mg hpus (arborvitae) borax veneta 3x 27 mg hpus (borate of sodium) kreosotum 12x 27 mg hpus (beechwood kreosote) pulsatilla pratensis 30x 27 mg hpus (wind flower) for the relief of external and internal irritation, burning, itching, and discharge associated with vaginal yeast overgrowth.^ the letters "hpus" indicate that the component in this product is officially monographed in the homeopathic pharmacopoeia of the united states.
Product Elements:
Gy-na-tren boric acid, marigold, coneflower, arborvitae, borate of sodium, beechwood kreosote, wind flower, lactobacillus acidophilus, vitamin c gy-na-tren lactobacillus acidophilus, vitamin c powdered cellulose leucine potato chickpea hypromellose, unspecified lactobacillus acidophilus lactobacillus acidophilus ascorbic acid ascorbic acid none none none gy-na-tren boric acid, marigold, coneflower, arborvitae, borate of sodium, beechwood kreosote, wind flower powdered cellulose gelatin hypromellose, unspecified coconut oil potato sodium ascorbate sodium phosphate boric acid boric acid wood creosote wood creosote sodium borate borate ion pulsatilla pratensis pulsatilla pratensis calendula officinalis flowering top calendula officinalis flowering top echinacea angustifolia echinacea angustifolia thuja occidentalis leafy twig thuja occidentalis leafy twig
Indications and Usage:
Temporarily relieves symptoms associated with vaginal yeast overgrowth.^
Warnings:
For vaginal use only. do not ingest use while using a tampon use if you are pregnant or suspect you are pregnant use if you have a known hypersensitivity to any ingredient in the product ask a doctor before use if you experiencing pelvic or vaginal pain are having a high fever are experiencing vaginal discharge with a foul smell are under a doctor's care for any serious condition have a sexually tansmitted disease (std), pelvic inflammatory disease (pid), or urinary tract infection (uti) stop use and ask a doctor if you experience vaginal pain high fever severe irritation or burning vaginal discharge with a foul smell symptoms persisting for more than 14 days or if they clear up and occur again within a few days a worsening condition âif pregnant or breast feeding, ask a health professional before use. âkeep out of reach of children.
Do Not Use:
For vaginal use only. do not ingest use while using a tampon use if you are pregnant or suspect you are pregnant use if you have a known hypersensitivity to any ingredient in the product ask a doctor before use if you experiencing pelvic or vaginal pain are having a high fever are experiencing vaginal discharge with a foul smell are under a doctor's care for any serious condition have a sexually tansmitted disease (std), pelvic inflammatory disease (pid), or urinary tract infection (uti) stop use and ask a doctor if you experience vaginal pain high fever severe irritation or burning vaginal discharge with a foul smell symptoms persisting for more than 14 days or if they clear up and occur again within a few days a worsening condition âif pregnant or breast feeding, ask a health professional before use. âkeep out of reach of children.
Dosage and Administration:
(for complete directions see insert) wash hands before use when vaginal area is clean and dry, using your index finger, gently insert v-capsul into your vagine as far as comfortable adults and children over 12 years of age: insert one capsule daily before bedtime repeat for 14 consecutive days the use of a panty liner is recommended during the application of this product children under 12 years of age: consult a doctor
Stop Use:
Stop use and ask a doctor if you experience vaginal pain high fever severe irritation or burning vaginal discharge with a foul smell symptoms persisting for more than 14 days or if they clear up and occur again within a few days a worsening condition
Description:
^indications based on homeopathic materia medica for self limiting conditions. these statements have not been evaluated by the food and drug administration.
Package Label Principal Display Panel:
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Further Questions:
Call 1.800.992.3323 between 7am and 4pm pacific time