Yeast Gard Advanced
Berberis Vulgaris, Borax, Collinsonia Canadensis, Hamamelis Virginiana
Wisconsin Pharmacal Company
Human Otc Drug
NDC 68093-0668Yeast Gard Advanced also known as Berberis Vulgaris, Borax, Collinsonia Canadensis, Hamamelis Virginiana is a human otc drug labeled by 'Wisconsin Pharmacal Company'. National Drug Code (NDC) number for Yeast Gard Advanced is 68093-0668. This drug is available in dosage form of Douche. The names of the active, medicinal ingredients in Yeast Gard Advanced 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 Advanced drug is Active.
Drug Information:
| Drug NDC: | 68093-0668 |
| 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 Advanced |
| 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: | Berberis Vulgaris, Borax, Collinsonia Canadensis, 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: | Douche |
| 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 Oct, 2007 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 25 Jun, 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: | 0012277668456
|
| 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 |
|---|
| 68093-0668-1 | 2 BOTTLE in 1 CARTON (68093-0668-1) / 133.07 g in 1 BOTTLE | 01 Oct, 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 vaginal itching, burning and irritation
Product Elements:
Yeast gard advanced berberis vulgaris, borax, collinsonia canadensis, hamamelis virginiana hamamelis virginiana root bark/stem bark hamamelis virginiana root bark/stem bark berberis vulgaris root bark berberis vulgaris root bark sodium benzoate sodium lauryl sulfate bacillus coagulans edetate disodium edetic acid maltodextrin citric acid monohydrate water sodium borate borate ion collinsonia canadensis root collinsonia canadensis root sodium phosphate, tribasic, anhydrous
Indications and Usage:
Uses uses for the temporary relief of symptoms associated with vagianl yeast infection, including: itching burning irritation
Warnings:
Warnings use only as directed for vaginal use only 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 stop use and ask a doctor if: symptoms last more than 7 days you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vagina. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. keep out of reach of children. if swallowed, get medial help
Read more...or contact a poison control center right away do not use if you have never had a vaginal yeast infection diagnosed by a doctor when using this product if you do not get complete relief ask a doctor before using another product
Do Not Use:
Warnings use only as directed for vaginal use only 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 stop use and ask a doctor if: symptoms last more than 7 days you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vagina. if pregnant or breast-feeding, ask a health professional before use. keep out of reach of children. keep out of reach of children. if swallowed, get medial help or contact a poison control center right away do not use if you have never had a vaginal yeast infection diagnosed by a doctor when using this product if you do not get complete relief ask a doctor before using another product
When Using:
When using this product if you do not get complete relief ask a doctor before using another product
Dosage and Administration:
Directions directions tamper evident: if the foil seal on bottle opening is missing, torn or damaged in any way, do not use. wash hands thoroughly with soap and water before and after use remove cap and safety seal from bottle. carefully open teh packet and pour homeopathic contents into the douche bottle. screw cap back onto bottle and shake thoroughly to fully mix powder into solution. after fully mixed, remove cap. remove sanitary wrap from nozzle. screw nozzle onto douche bottle. slowly insert nozzle into vagina about 3 inches. if needed, a small amount of personal lubricant can be applied to nozzle to ease insertion of nozzle into vagina. gently squeeze bottle until solution is dispensed. use while sittion on the toilet, standing in the shower or in the tub. after douching discard bottle and nozzle.
Stop Use:
Stop use and ask a doctor if: symptoms last more than 7 days you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vagina.
Package Label Principal Display Panel:
Carton
Further Questions:
Questions or commetns? 1-800-635-3696