V-bella
Boric Acid
U.s. Pharmaceutical Corporation
Human Otc Drug
NDC 52747-155V-bella also known as Boric Acid is a human otc drug labeled by 'U.s. Pharmaceutical Corporation'. National Drug Code (NDC) number for V-bella is 52747-155. This drug is available in dosage form of Suppository. The names of the active, medicinal ingredients in V-bella drug includes Boric Acid - 3 [hp_X]/1 . The currest status of V-bella drug is Active.
Drug Information:
| Drug NDC: | 52747-155 |
| 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: | V-bella |
| 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 |
| 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: | 01 Aug, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 08 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 |
|---|
| 52747-155-03 | 3 PACKET in 1 CARTON (52747-155-03) / 1 SUPPOSITORY in 1 PACKET | 01 Aug, 2020 | 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 restores vaginal ph and relieves vaginal itching, burning and irritation.
Product Elements:
V-bella boric acid maltodextrin .alpha.-tocopherol acetate, dl- ascorbic acid lacticaseibacillus casei lactobacillus gasseri pullulan boric acid boric acid
Indications and Usage:
Uses treats and relieves symptoms of vaginal and urinary infections. rebalances vaginal ph and restores normal vaginal health. helps relieve symptoms of external and internal vaginal burning, itching, irritation and dryness. helps reduce vaginal odor due to vaginal infections.
Warnings:
Warnings for vaginal use only
Do Not Use:
Warnings for vaginal use only
When Using:
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 more serious condition. vaginal yeast infection often (such as once a month or 3 in 6 months). you could be pregnant or a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system. been exposed to human immunodeficiency virus (hiv) that causes aids. ask a doctor or pharmacist before use if you are taking prescription blood thinning medicine warfarin, because bleeding or bruising may occur. when using this product 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). do not have vaginal intercourse mild increase in vaginal burning, itching or irritation may occur if you do not get complete relief ask a doctor before using another product
Dosage and Administration:
Directions before using this product, read all consumer information provided on carton and insert, adults and children 12 years of age and over: place vaginal capsule suppository in applicator and gently insert into the vagina. for acute infection, use one (1) capsule suppository a day for three (3) days for chronic infection, use an additional package of three (3) vaginal capsule suppositories throw applicator away after each use children under 12 years of age: ask a doctor
Stop Use:
Stop use and ask a doctor if symptoms do not get better in 3 days symptoms last more than 7 days 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.
How Supplied:
How supplied, storage and handling v-bella ⢠is supplied in a clear natural plantcap capsule in three (3) individual foil packets of one (1) capsule each, ndc # 52747-0155-03 with three (3) disposable vaginal applicators in each carton. avoid sunlight and store unopened pouches at 15Ë to 30Ë c (59Ë to 86Ë f) other information v-bella ⢠is not a contraceptive and should not be used to prevent pregnancy or to prevent or treat sexually transmitted diseases (stds). do not use if suppository pouch seal is compromised do not use if seal over applicator has been punctured do not purchase if carton is open
Package Label Principal Display Panel:
Package label - principal display panel label