Balance
FDA Label NDC 54616-001

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Bdmp, Llc for the product Balance (NDC 54616-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, otc - keep out of reach of children, directions, inactive ingredients, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Each dose contains:Bryonia 10C, 20C, 30C HPUSIgnatia 10C, 20C, 30C HPUSNux Vom 10C, 20C, 30C HPUSPhos 10C, 20C, 30C HPUSSepia 10C, 20C, 30C HPUSThe letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Purpose

Bryonia 10C, 20C, 30C HPUS.....................Minor headache, SleeplessnessIgnatia 10C, 20C, 30C HPUS......................Sexual frigidity, Changeable moodNux Vom 10C, 20C, 30C HPUS..................Faintness, SleeplessnessPhos 10C, 20C, 30C HPUS........................Aversion to coitus, Great indifferenceSepia 10C, 20C, 30C HPUS........................Hot flashes, Weakness

Uses

Temporarily relieves symptoms of menstrual irregularities such as: membrane dryness, hot flashes, sleeplessness, weakness or faintness, perspiration, sexual frigidity and minor headache pain as per Homeopathic Materia Medica.

Warnings

If pregnant or breast feeding, ask a health professional before use. 

In case of overdose get medical help or contact a Poison Control Center right away.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Directions

Shake well before using. Spay 3 to 6 sprays under the tongue 3 times a day or as needed. Adults and children under 18 years of age consult a physician.

Inactive Ingredients

Barbasco Extract, Black Cohosh Extract, Damiana, Eleuthero, Malic Acid, Muira Puama,

Natural Flavors, Potassium Sorbate, Sodium Benzoate, Stevia Leaf Extract, Tribulus, Water.

Storage And Handling

Safety-sealed for your protection. Do not use if seal is missing or broken.


Otc - Questions

Questions? Comments?

877-272-6611

Distributed by

BDMP LLC

1080 Bichara Boulevard

Lady Lake, Fl. 32159

Made in the USA

Description

Temporarily relieves symptoms of menstrual irregularities such as hot flashes, sleeplessness, weakness or

faintness and low libido.


Homeopathic Spray

Principal Display Panel

Mm1 (Balancelabel)

Mm1 (Balancelabel)

NDC 54616-001-00

                           BALANCE

                           BY FEMBALANCE

2 fl oz (60 mL)    Homeopathic Spray

Temporarily relieves symptoms of menstrual irregularities such as

hot flashes sleeplessness, weakness or faintness and low libido.


* Please review the disclaimer below.