Yeast Gard Homeopathic Gel Homeopathic Gel Treatment
Borax, Collinsonia Canadensis, Berberis Vulgaris, Hamamelis Virginiana
Wisconsin Pharmacal Company
Human Otc Drug
NDC 68093-7247Yeast Gard Homeopathic Gel Homeopathic Gel Treatment also known as Borax, Collinsonia Canadensis, Berberis Vulgaris, Hamamelis Virginiana is a human otc drug labeled by 'Wisconsin Pharmacal Company'. National Drug Code (NDC) number for Yeast Gard Homeopathic Gel Homeopathic Gel Treatment is 68093-7247. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Yeast Gard Homeopathic Gel Homeopathic Gel Treatment drug includes Berberis Vulgaris Root Bark - 6 [hp_X]/g Collinsonia Canadensis Root - 3 [hp_X]/g Hamamelis Virginiana Root Bark/stem Bark - 6 [hp_X]/g Sodium Borate - 3 [hp_X]/g . The currest status of Yeast Gard Homeopathic Gel Homeopathic Gel Treatment drug is Active.
Drug Information:
| Drug NDC: | 68093-7247 |
| 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: | Yeast Gard Homeopathic Gel Homeopathic Gel Treatment |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Yeast Gard Homeopathic Gel |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Homeopathic Gel Treatment |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| 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: | Borax, Collinsonia Canadensis, Berberis Vulgaris, Hamamelis Virginiana |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Wisconsin Pharmacal Company |
| 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: | BERBERIS VULGARIS ROOT BARK - 6 [hp_X]/g
COLLINSONIA CANADENSIS ROOT - 3 [hp_X]/g
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - 6 [hp_X]/g
SODIUM BORATE - 3 [hp_X]/g
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | VAGINAL
|
| 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: | 01 Apr, 2007 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 14 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: | Wisconsin Pharmacal Company
|
| 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: | 0012277665011
|
| UPC stands for Universal Product Code. |
| UNII: | 1TH8Q20J0U
O2630F3XDR
T7S323PKJS
91MBZ8H3QO
|
| 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 |
|---|
| 68093-7247-1 | 1 TUBE in 1 CARTON (68093-7247-1) / 28.35 g in 1 TUBE | 01 Apr, 2007 | 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 temporary relief from external vagianl discomfort including itching, burning, and irritation
Product Elements:
Yeast gard homeopathic gel homeopathic gel treatment borax, collinsonia canadensis, berberis vulgaris, hamamelis virginiana propanediol xanthan gum sodium hydroxide sodium benzoate gluconolactone hamamelis virginiana root bark/stem bark hamamelis virginiana root bark/stem bark edetate disodium edetic acid allantoin, (+)- benzalkonium chloride water polysorbate 20 tea tree oil collinsonia canadensis root collinsonia canadensis root sodium borate borate ion berberis vulgaris root bark berberis vulgaris root bark
Indications and Usage:
Uses for temporary relief of symptoms associate with vaginal yeast infection, including:itching, burning, and irritation.
Warnings:
Warnings for external vaginal use only. use only as directed. keep out of reach of children. if swallowed, get medial help or contact a poison control center right away. if in eyes, flush with water for 15 minutes and call a physician. stop use and ask doctor if symptoms worsen, last more than 7 days, or clear up and occur again within a few days. you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. do not use if you have never had a vaginal yeast infection diagnosed by a doctor. when using this product wash hands thoroughly with soap and water before and after use avoid contact with eyes if burning sensation occurs and lasts more than a few minutes, remove gel and discontinue use do not use more than one week unless directed by a doctor if yoyu do not get complete relief ask a doctor before using another product. ask a doctor before use if you have vaginal itching and discomfort for the first time lower abdominal, back or should
Read more...er pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. you may have a serious condition. vaginal yeast infections often (such as once a month or 3 in 6 months). you could be pregnant or have a serious underlying medical cause for you symptoms, including diabetes or a weakened immune system. been exposed to the human immunodeficiency virus (hiv) that causes aids you have an std (sexually transmitted disease) or pid (pelvic inflammatory disease) you have frequent and painful urination if pregnant or breast-feeding , ask a health professional before use.
Do Not Use:
Warnings for external vaginal use only. use only as directed. keep out of reach of children. if swallowed, get medial help or contact a poison control center right away. if in eyes, flush with water for 15 minutes and call a physician. stop use and ask doctor if symptoms worsen, last more than 7 days, or clear up and occur again within a few days. you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. do not use if you have never had a vaginal yeast infection diagnosed by a doctor. when using this product wash hands thoroughly with soap and water before and after use avoid contact with eyes if burning sensation occurs and lasts more than a few minutes, remove gel and discontinue use do not use more than one week unless directed by a doctor if yoyu do not get complete relief ask a doctor before using another product. ask a doctor before use if you have vaginal itching and discomfort for the first time lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. you may have a serious condition. vaginal yeast infections often (such as once a month or 3 in 6 months). you could be pregnant or have a serious underlying medical cause for you symptoms, including diabetes or a weakened immune system. been exposed to the human immunodeficiency virus (hiv) that causes aids you have an std (sexually transmitted disease) or pid (pelvic inflammatory disease) you have frequent and painful urination if pregnant or breast-feeding , ask a health professional before use.
When Using:
When using this product wash hands thoroughly with soap and water before and after use avoid contact with eyes if burning sensation occurs and lasts more than a few minutes, remove gel and discontinue use do not use more than one week unless directed by a doctor if yoyu do not get complete relief ask a doctor before using another product.
Dosage and Administration:
Directions directions apply to affected area as often as needed. because the area is irritated, you could experience a slight burning sensation. if this persists more than a few minutes, remove gel and discontinue use. wash hand thoroughly with soap an dwater before and after use. do not use for children under two years. consult a doctor if condition persists.
Stop Use:
Stop use and ask doctor if symptoms worsen, last more than 7 days, or clear up and occur again within a few days. you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge.
Package Label Principal Display Panel:
Tube carton
Further Questions:
Questions or comments? 1-800-635-3696