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.
Updated August 25, 2020
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- Active Ingredient
- Do not use
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
- KEEP OUT OF REACH OF CHILDREN
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)
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
- 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
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.
BeBe & Bella, LLC
2443 Park Central Blvd.
Decatur, GA 30035, USA
- Package Label - Principal Display Panel
INGREDIENTS AND APPEARANCE
boric acid suppository
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52747-155 Route of Administration VAGINAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BORIC ACID (UNII: R57ZHV85D4) (BORIC ACID - UNII:R57ZHV85D4) BORIC ACID 3 [hp_X] Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:52747-155-03 3 in 1 CARTON 08/01/2020 1 1 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 08/01/2020 Labeler - US Pharmaceutical Corporation (048318224)