Hylafem Boricum Acidum 3x
Boricum Acidum
U.s. Pharmaceutical Corporation
Human Otc Drug
NDC 52747-255Hylafem Boricum Acidum 3x also known as Boricum Acidum is a human otc drug labeled by 'U.s. Pharmaceutical Corporation'. National Drug Code (NDC) number for Hylafem Boricum Acidum 3x is 52747-255. This drug is available in dosage form of Suppository. The names of the active, medicinal ingredients in Hylafem Boricum Acidum 3x drug includes Boric Acid - 3 [hp_X]/1 . The currest status of Hylafem Boricum Acidum 3x drug is Active.
Drug Information:
| Drug NDC: | 52747-255 |
| 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: | Hylafem Boricum Acidum 3x |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Hylafem |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | BORICUM ACIDUM 3X |
| 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: | Boricum Acidum |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | U.s. Pharmaceutical Corporation |
| 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 [hp_X]/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: | 09 Dec, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 09 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: | U.S. PHARMACEUTICAL CORPORATION
|
| 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: | 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 |
|---|
| 52747-255-03 | 1 CAPSULE in 1 CARTON (52747-255-03) / 3 SUPPOSITORY in 1 CAPSULE | 09 Dec, 2019 | 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:
Product Elements:
Hylafem boricum acidum 3x boricum acidum maltodextrin .alpha.-tocopherol acetate ascorbic acid lacticaseibacillus casei lactobacillus gasseri boric acid boric acid
Indications and Usage:
Uses ï§ treats and relieves symptoms of vaginal and urinary infections ï§ rebalances vaginal ph and restores normal vaginal health ï§ helps relieve symptoms of external and internal vaginal burning, itching, irritation and dryness ï§ helps reduce vaginal odor due to vaginal infections
Warnings:
Warnings for vaginal use only do not use if you have never had a vaginal yeast infection diagnosed by a doctor.
When Using:
When using this product ï§ do not use tampons, douches, spermicides or other vaginal products. condoms and diaphragms may be damaged and fail to prevent pregnancy or sexual transmitted disease (stds). ï§ do not have vaginal intercourse ï§ mild increase in vaginal burning, itching or irritation may occur ï§ if you do not get complete relief ask a doctor before using another product
Dosage and Administration:
Other information ï§ hylafem ph is not a contraceptive and should not be used to prevent pregnancy or to prevent or treat sexually transmitted diseases (stds). ï§ do not use if suppository pouch seal is compromised ï§ do not use if seal over applicator has been punctured ï§ do not purchase if carton is open
Stop Use:
Stop use and ask a doctor if ï§ symptoms do not get better in 3 days ï§ symptoms last more than 7 days ï§ you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. 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 (1-800-222-1222) right away.
Adverse Reactions:
Adverse reactions and side effects the adverse effects are considered mild and may include watery discharge, erythema, or slight burning sensation. you should contact your healthcare provider for medical advice about adverse events or report a serious adverse event, by contacting us pharmaceutical corporation at the address listed below. distributed by: us pharmaceutical corporation 2443 park central blvd decatur, ga 30035, usa
How Supplied:
How supplied, storage and handling hylafem ph is supplied in a clear natural plantcap capsule in three (3) individual foil packets of one (1) capsule each, ndc # 52747-0255-03 with three (3) disposable vaginal applicators in each carton. avoid sunlight and store unopened pouches at 15Ë to 30Ë c (59Ë to 86Ë f)
Package Label Principal Display Panel:
Product label label