8010500e-451e-4a80-9908-20950e8f69f9

SPL v1

SPL

SPL Set ID 8010500e-451e-4a80-9908-20950e8f69f9

Route

sublingual

Published

Effective Date 2013-02-21

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

bryonia alba root (30 [hp_C]) strychnos ignatii seed strychnos nux-vomica seed phosphorus sepia officinalis juice

Inactive Ingredients

barbasco black cohosh turnera diffusa leafy twig eleuthero malic acid dulacia inopiflora wood potassium sorbate sodium benzoate stevia rebaudiuna leaf tribulus terrestris water

Identifiers & Packaging

Marketing Status

unapproved homeopathic active Since 2013-02-21

Purpose

Bryonia 10C, 20C, 30C HPUS.....................Minor headache, Sleeplessness Ignatia 10C, 20C, 30C HPUS......................Sexual frigidity, Changeable mood Nux Vom 10C, 20C, 30C HPUS..................Faintness, Sleeplessness Phos 10C, 20C, 30C HPUS........................Aversion to coitus, Great indifference Sepia 10C, 20C, 30C HPUS........................Hot flashes, Weakness

Description

Each dose contains: Bryonia 10C, 20C, 30C HPUS Ignatia 10C, 20C, 30C HPUS Nux Vom 10C, 20C, 30C HPUS Phos 10C, 20C, 30C HPUS Sepia 10C, 20C, 30C HPUS The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Medication Information

Warnings and Precautions

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

Warnings

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

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.

Purpose

Bryonia 10C, 20C, 30C HPUS.....................Minor headache, Sleeplessness

Ignatia 10C, 20C, 30C HPUS......................Sexual frigidity, Changeable mood

Nux Vom 10C, 20C, 30C HPUS..................Faintness, Sleeplessness

Phos 10C, 20C, 30C HPUS........................Aversion to coitus, Great indifference

Sepia 10C, 20C, 30C HPUS........................Hot flashes, Weakness

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.

Description

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

faintness and low libido.

Homeopathic Spray

Principal Display Panel

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.

Section 44425-7

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

Section 50565-1

Keep out of reach of children.

Section 53413-1

Questions? Comments?

877-272-6611

Distributed by

BDMP LLC

1080 Bichara Boulevard

Lady Lake, Fl. 32159

Made in the USA

Active Ingredients

Each dose contains:

Bryonia 10C, 20C, 30C HPUS

Ignatia 10C, 20C, 30C HPUS

Nux Vom 10C, 20C, 30C HPUS

Phos 10C, 20C, 30C HPUS

Sepia 10C, 20C, 30C HPUS

The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Structured Label Content

Warnings and Precautions (34071-1)

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

Warnings

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

Uses

Purpose

Bryonia 10C, 20C, 30C HPUS.....................Minor headache, Sleeplessness

Ignatia 10C, 20C, 30C HPUS......................Sexual frigidity, Changeable mood

Nux Vom 10C, 20C, 30C HPUS..................Faintness, Sleeplessness

Phos 10C, 20C, 30C HPUS........................Aversion to coitus, Great indifference

Sepia 10C, 20C, 30C HPUS........................Hot flashes, Weakness

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.

Description (34089-3)

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

faintness and low libido.

Homeopathic Spray

Principal Display Panel

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.

Section 44425-7 (44425-7)

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

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 53413-1 (53413-1)

Questions? Comments?

877-272-6611

Distributed by

BDMP LLC

1080 Bichara Boulevard

Lady Lake, Fl. 32159

Made in the USA

Active Ingredients

Each dose contains:

Bryonia 10C, 20C, 30C HPUS

Ignatia 10C, 20C, 30C HPUS

Nux Vom 10C, 20C, 30C HPUS

Phos 10C, 20C, 30C HPUS

Sepia 10C, 20C, 30C HPUS

The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

Advanced Ingredient Data

[{"name": "BRYONIA ALBA ROOT", "unii": "T7J046YI2B", "classCode": "ACTIB", "strengthNumerator": "30", "strengthDenominator": "60", "strengthNumeratorUnit": "[hp_C]", "strengthDenominatorUnit": "mL"}, {"name": "STRYCHNOS IGNATII SEED", "unii": "1NM3M2487K", "classCode": "ACTIB", "strengthNumerator": "30", "strengthDenominator": "60", "strengthNumeratorUnit": "[hp_C]", "strengthDenominatorUnit": "mL"}, {"name": "STRYCHNOS NUX-VOMICA SEED", "unii": "269XH13919", "classCode": "ACTIB", "strengthNumerator": "30", "strengthDenominator": "60", "strengthNumeratorUnit": "[hp_C]", "strengthDenominatorUnit": "mL"}, {"name": "PHOSPHORUS", "unii": "27YLU75U4W", "classCode": "ACTIB", "strengthNumerator": "30", "strengthDenominator": "60", "strengthNumeratorUnit": "[hp_C]", "strengthDenominatorUnit": "mL"}, {"name": "SEPIA OFFICINALIS JUICE", "unii": "QDL83WN8C2", "classCode": "ACTIB", "strengthNumerator": "30", "strengthDenominator": "60", "strengthNumeratorUnit": "[hp_C]", "strengthDenominatorUnit": "mL"}, {"name": "BARBASCO", "unii": "5ZAQ44W04C", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BLACK COHOSH", "unii": "K73E24S6X9", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TURNERA DIFFUSA LEAFY TWIG", "unii": "RQ2CFA7WWJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ELEUTHERO", "unii": "ZQH6VH092Z", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MALIC ACID", "unii": "817L1N4CKP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DULACIA INOPIFLORA WOOD", "unii": "K04M7D9VEC", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POTASSIUM SORBATE", "unii": "1VPU26JZZ4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEVIA REBAUDIUNA LEAF", "unii": "6TC6NN0876", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRIBULUS TERRESTRIS", "unii": "4X4HLN92OT", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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.", "34071-1": "In case of overdose get medical help or contact a Poison Control Center right away.", "34089-3": "Temporarily relieves symptoms of menstrual irregularities such as hot flashes, sleeplessness, weakness or faintness and low libido. Homeopathic Spray", "44425-7": "Safety-sealed for your protection. Do not use if seal is missing or broken.", "50565-1": "Keep out of reach of children.", "53413-1": "Questions? Comments? 877-272-6611 Distributed by BDMP LLC 1080 Bichara Boulevard Lady Lake, Fl. 32159 Made in the USA", "Purpose": "Bryonia 10C, 20C, 30C HPUS.....................Minor headache, Sleeplessness Ignatia 10C, 20C, 30C HPUS......................Sexual frigidity, Changeable mood Nux Vom 10C, 20C, 30C HPUS..................Faintness, Sleeplessness Phos 10C, 20C, 30C HPUS........................Aversion to coitus, Great indifference Sepia 10C, 20C, 30C HPUS........................Hot flashes, Weakness", "Warnings": "If pregnant or breast feeding, ask a health professional before use. ", "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.", "Active Ingredients": "Each dose contains: Bryonia 10C, 20C, 30C HPUS Ignatia 10C, 20C, 30C HPUS Nux Vom 10C, 20C, 30C HPUS Phos 10C, 20C, 30C HPUS Sepia 10C, 20C, 30C HPUS The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.", "Inactive Ingredients": "Barbasco Extract, Black Cohosh Extract, Damiana, Eleuthero, Malic Acid, Muira Puama, Natural Flavors, Potassium Sorbate, Sodium Benzoate, Stevia Leaf Extract, Tribulus, Water.", "Principal Display Panel": "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."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:09:11.812065 · Updated: 2026-03-14T23:14:22.697