Label: BALANCE- bryonia, ignatia, nux vom, phos, sepia spray
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Contains inactivated NDC Code(s)
NDC Code(s): 54616-001-60 - Packager: BDMP, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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.
Drug Label Information
Updated February 21, 2013
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- Active Ingredients
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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
- Warnings
- KEEP OUT OF REACH OF CHILDREN
- WARNINGS
- Directions
- Inactive Ingredients
- STORAGE AND HANDLING
- QUESTIONS
- DESCRIPTION
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
BALANCE
bryonia, ignatia, nux vom, phos, sepia sprayProduct 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)