Label: V-BELLA- boric acid suppository

  • NDC Code(s): 52747-155-03
  • Packager: US Pharmaceutical Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated August 25, 2020

If you are a consumer or patient please visit this version.

  • 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.

  • 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
  • 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.

  • 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 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 15˚ to 30˚ C (59˚ to 86˚ 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
  • 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

  • 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, LLC
    2443 Park Central Blvd.
    Decatur, GA 30035, USA

  • Package Label - Principal Display Panel

    Label

  • INGREDIENTS AND APPEARANCE
    V-BELLA 
    boric acid suppository
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52747-155
    Route of AdministrationVAGINAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BORIC ACID (UNII: R57ZHV85D4) (BORIC ACID - UNII:R57ZHV85D4) BORIC ACID3 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    LACTOBACILLUS CASEI (UNII: SA940P2U00)  
    LACTOBACILLUS GASSERI (UNII: Q66E0D2443)  
    PULLULAN (UNII: 8ZQ0AYU1TT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52747-155-033 in 1 CARTON08/01/2020
    11 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/01/2020
    Labeler - US Pharmaceutical Corporation (048318224)