VagiBiom - Vaginal Health Suppositories

VagiBiom by

Drug Labeling and Warnings

VagiBiom by is a Homeopathic medication manufactured, distributed, or labeled by Biom Pharmaceutical Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

VAGIBIOM- homeopathic suppository for yeast infections suppository 
Biom Pharmaceutical Corporation

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.

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VagiBiom - Vaginal Health Suppositories

Active Ingredients

SODIUM BORATE

HAMAMELIS VIRGINIANA TOP

Purpose

Temporary relief from symptoms of Vaginal yeast infection

Uses

For the temporary relief of symptoms associated with Vaginal yeast infections including

• Itching
• Burning
• Irritation

Warnings For vaginal use only.

Use only as directed.

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

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 infections often (such as once a month or 3 in 6 months). You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system.
• Been exposed to the human immunodeficiency virus (HIV) that causes AIDS .
• You have an STD (sexually transmitted disease) or PID (pelvic inflammatory disease).
• You have frequent and painful urination.

When using this product.

If you do not get complete relief ask a doctor before using another product.

Stop use and ask a doctor if

• 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.

If swallowed, get medical help or contact a Poison Control Center right away.

Other information.

• Suppositories are not a contraceptive and should not be used to prevent pregnancy.
• Do not. Use it foil seal on suppositories is torn, open or incompletely sealed. Purchase if carton is open.
• Store at room temperature.
• Lot number and expiration dates: see bottom of box.

DIRECTIONS FOR USE:

Wash hands, insert suppository deep into vagina for oil to dissolve. Wear panty liner if there is leakage. To clear yeast infection use three suppositories in three consecutive days; after two days use one suppository every other day (5 dose).

Inactive Ingredients

COCONUT OIL, HYALURONIC ACID, LACTIC ACID, LECITHIN, SOYBEAN, MALTODEXTRIN

VAGIBIOM 
homeopathic suppository for yeast infections suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72959-002
Route of Administration	VAGINAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM BORATE (UNII: 91MBZ8H3QO) (BORATE ION - UNII:44OAE30D22)	SODIUM BORATE	3 [hp_X]
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS)	HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK	6 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
COCONUT OIL (UNII: Q9L0O73W7L)
HYALURONIC ACID (UNII: S270N0TRQY)
LACTIC ACID (UNII: 33X04XA5AT)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
MALTODEXTRIN (UNII: 7CVR7L4A2D)

Product Characteristics
Color	white	Score
Shape	BULLET	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72959-002-02	5 in 1 BOX; Type 0: Not a Combination Product	10/08/2021	03/10/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		10/08/2021	03/10/2022

Labeler - Biom Pharmaceutical Corporation (080828422)

Establishment
Name	Address	ID/FEI	Business Operations
Biom Pharmaceutical Corporation		080828422	manufacture(72959-002)

Revised: 1/2023

Document Id: af8ec108-0bea-4f3a-b43c-3768752064ec

34390-5

Set id: 990df28c-fe76-4712-874c-26d09c5ee0f9

Version: 3

Effective Time: 20230127