Canagyn
Homeopathic Antifungal
Palcare Enterprises Inc
Human Otc Drug
NDC 82349-120Canagyn also known as Homeopathic Antifungal is a human otc drug labeled by 'Palcare Enterprises Inc'. National Drug Code (NDC) number for Canagyn is 82349-120. This drug is available in dosage form of Suppository. The names of the active, medicinal ingredients in Canagyn drug includes Boric Acid - .3 mg/1 . The currest status of Canagyn drug is Active.
Drug Information:
| Drug NDC: | 82349-120 |
| 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: | Canagyn |
| 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: | Homeopathic Antifungal |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Palcare Enterprises Inc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Suppository |
| 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: | BORIC ACID - .3 mg/1
|
| 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 Feb, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 07 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, 2024 |
| 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: | Palcare Enterprises 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. |
| UPC: | 0896968000677
|
| UPC stands for Universal Product Code. |
| UNII: | R57ZHV85D4
|
| 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 |
|---|
| 82349-120-77 | 14 SUPPOSITORY in 1 BOX (82349-120-77) | 01 Feb, 2022 | 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 antifungal
Product Elements:
Canagyn homeopathic antifungal glyceryl ricinoleate ceteareth-25 lactic acid hydrogenated coco-glycerides boric acid boric acid sodium lactate, l-
Indications and Usage:
Use uses: helps reduce the overgrowth of recurrent or resistant vaginal yeast. relieve recurrent vaginal infections such as candidiasis. helps to reduce the incidence of recurrent vulvovaginal candidiasis. relieves secretions associated with vaginitis. helps to treat symptoms of recurrent yeast vaginitis and vulvovaginal candidiasis.
Warnings:
Warnings not for oral use. there is enough boron in this package to cause serious harm if ingested. consult a health care practitioner if symptoms persist or worsen. consult a health care practitioner prior to use if you have been diagnosed with estrogen-dependent cancer or if you have a kidney disorder
Do Not Use:
Warnings not for oral use. there is enough boron in this package to cause serious harm if ingested. consult a health care practitioner if symptoms persist or worsen. consult a health care practitioner prior to use if you have been diagnosed with estrogen-dependent cancer or if you have a kidney disorder
When Using:
Consult a health care practitioner if symptoms persist or worsen. consult a health care practitioner prior to use if you have been diagnosed with estrogen-dependent cancer or if you have a kidney disorder
Dosage and Administration:
Directions insert 1 suppository per day into the vagina before bedtime for 14 consecutive days.
Stop Use:
Discontinue use and consult a healthcare practitioner if you experience vaginal pain, irritation or burning. symptoms such as burning sensation, watery discharge, and erythema have been known to occur.
Package Label Principal Display Panel:
Package label - principal display panel canagyn antifungal