NDC 52747-155 V-bella

Boric Acid

NDC Product Code 52747-155

NDC 52747-155-03

Package Description: 3 PACKET in 1 CARTON > 1 SUPPOSITORY in 1 PACKET

NDC Product Information

V-bella with NDC 52747-155 is a a human over the counter drug product labeled by Us Pharmaceutical Corporation. The generic name of V-bella is boric acid. The product's dosage form is suppository and is administered via vaginal form.

Labeler Name: Us Pharmaceutical Corporation

Dosage Form: Suppository - A solid body of various weights and shapes, adapted for introduction into the rectal orifice of the human body; they usually melt, soften, or dissolve at body temperature.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

V-bella Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • BORIC ACID 3 [hp_X]/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • MALTODEXTRIN (UNII: 7CVR7L4A2D)
  • .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
  • ASCORBIC ACID (UNII: PQ6CK8PD0R)
  • LACTOBACILLUS CASEI (UNII: SA940P2U00)
  • LACTOBACILLUS GASSERI (UNII: Q66E0D2443)
  • PULLULAN (UNII: 8ZQ0AYU1TT)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Vaginal - Administration into the vagina.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Us Pharmaceutical Corporation
Labeler Code: 52747
Marketing Category: UNAPPROVED HOMEOPATHIC - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/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.

Start Marketing Date: 08-01-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

V-bella Product Label Images

V-bella Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredient

Boricum Acidum 3X* HPUS***X is a homeopathic dilution. **The letters HPUS indicates that this ingredient is officially monographed in the Homeopathic Pharmacopoeia of the United States.

Purpose

Restores vaginal pH and relieves vaginal itching, burning and irritation.

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

For vaginal use only

Do Not Use

Do not use if you have never had a vaginal yeast infection diagnosed by a doctor.

Otc - When Using

  • Ask a doctor before use if you havevaginal itching and discomfort for the first timelower 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 productdo 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 intercoursemild increase in vaginal burning, itching or irritation may occurif you do not get complete relief ask a doctor before using another product

Otc - Stop Use

  • Stop use and ask a doctor ifsymptoms do not get better in 3 dayssymptoms last more than 7 daysyou 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.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1- 800-222-1222) right away.

How Supplied

  • How supplied, storage and handlingV-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 15˚ to 30˚ C (59˚ to 86˚ F)Other informationV-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 compromiseddo not use if seal over applicator has been punctureddo not purchase if carton is open

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) daysfor chronic infection, use an additional package of three (3) vaginal capsule suppositoriesthrow applicator away after each useChildren under 12 years of age: ask a doctor

Other Information

  • Store between 15-30C (59-86F)Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients

Maltodextrin, Antioxidants-Vitamin E (DL-Alpha-Tocopheryl Acetate) &  Vitamin C (Ascorbic Acid), Lactobacillus casei (KE-99), Lactobacillus gasseri and Capsule Ingredient (Pullulan). 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 BeBe & Bella, LLC. at the address listed below. Distributed by: BeBe & Bella, LLC2443 Park Central Blvd.Decatur, GA 30035, USA

* Please review the disclaimer below.