Label: BALANCE - bryonia alba root, strychnos ignatii seed, strychnos nux-vomica seed, phosphorus and sepia officinalis juice spray
- NDC Code(s): 54616-001-60
- Packager: BDMP, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- 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.
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
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.Close
If pregnant or breast feeding, ask a health professional before use.Close
- KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children.Close
In case of overdose get medical help or contact a Poison Control Center right away.Close
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.Close
- Inactive Ingredients
Barbasco Extract, Black Cohosh Extract, Damiana, Eleuthero, Malic Acid, Muira Puama,
Natural Flavors, Potassium Sorbate, Sodium Benzoate, Stevia Leaf Extract, Tribulus, Water.Close
- STORAGE AND HANDLING
Safety-sealed for your protection. Do not use if seal is missing or broken.
1080 Bichara Boulevard
Lady Lake, Fl. 32159
Made in the USAClose
Temporarily relieves symptoms of menstrual irregularities such as hot flashes, sleeplessness, weakness or
faintness and low libido.
- Principal Display Panel
2 fl oz (60 mL) Homeopathic Spray
Temporarily relieves symptoms of menstrual irregularities such ashot flashes sleeplessness, weakness or faintness and low libido.
- INGREDIENTS AND APPEARANCE
bryonia, ignatia, nux vom, phos, sepia spray
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:54616-001 Route of Administration SUBLINGUAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BRYONIA ALBA ROOT (BRYONIA ALBA ROOT) BRYONIA ALBA ROOT 30 [hp_C] in 60 mL STRYCHNOS IGNATII SEED (STRYCHNOS IGNATII SEED) STRYCHNOS IGNATII SEED 30 [hp_C] in 60 mL STRYCHNOS NUX-VOMICA SEED (STRYCHNOS NUX-VOMICA SEED) STRYCHNOS NUX-VOMICA SEED 30 [hp_C] in 60 mL PHOSPHORUS (PHOSPHORUS) PHOSPHORUS 30 [hp_C] in 60 mL SEPIA OFFICINALIS JUICE (SEPIA OFFICINALIS JUICE) SEPIA OFFICINALIS JUICE 30 [hp_C] in 60 mL Inactive Ingredients Ingredient Name Strength BARBASCO BLACK COHOSH TURNERA DIFFUSA LEAFY TWIG ELEUTHERO MALIC ACID DULACIA INOPIFLORA WOOD POTASSIUM SORBATE SODIUM BENZOATE STEVIA REBAUDIUNA LEAF TRIBULUS TERRESTRIS WATER 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)