BALANCE- bryonia, ignatia, nux vom, phos, sepia spray

BALANCE by

Drug Labeling and Warnings

BALANCE by is a Homeopathic medication manufactured, distributed, or labeled by BDMP, LLC , Adjunct Therapeutics Manufacturing, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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

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. 

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

WARNINGS

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

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.

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

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.

INGREDIENTS AND APPEARANCE

BALANCE  
bryonia, ignatia, nux vom, phos, sepia spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54616-001
Route of Administration	SUBLINGUAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	30 [hp_C]  in 60 mL
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K)	STRYCHNOS IGNATII SEED	30 [hp_C]  in 60 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	30 [hp_C]  in 60 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	30 [hp_C]  in 60 mL
SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2)	SEPIA OFFICINALIS JUICE	30 [hp_C]  in 60 mL

Inactive Ingredients
Ingredient Name	Strength
BARBASCO (UNII: 5ZAQ44W04C)
BLACK COHOSH (UNII: K73E24S6X9)
TURNERA DIFFUSA LEAFY TWIG (UNII: RQ2CFA7WWJ)
ELEUTHERO (UNII: ZQH6VH092Z)
MALIC ACID (UNII: 817L1N4CKP)
DULACIA INOPIFLORA WOOD (UNII: K04M7D9VEC)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
TRIBULUS TERRESTRIS (UNII: 4X4HLN92OT)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54616-001-60	1 in 1 CARTON
1		60 mL in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		02/21/2013

Labeler - BDMP, LLC (078676990)

Establishment
Name	Address	ID/FEI	Business Operations
Adjunct Therapeutics Manufacturing, LLC		043042937	manufacture(54616-001)