BIOE CALM- aconitum napellus root, arsenic trioxide, sodium borate, activated charcoal, causticum, matricaria chamomilla, strychnos ignatii seed, lithium carbonate, sodium chloride, strychnos nux-vomica seed, lead, sepia officinalis juice, thuja occidentalis leafy twig, valerian liquid
BioEnergetics, Inc.

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.

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BioE Calm

Active Ingredients

Aconite 12x, Arsenicum alb 12x, Borax 9x, Carbo veg 12x, Causticum 6x, Chamomilla 6x, Ignatia 12x, Lithium carb 12x, Natrum mur 9x, Nux vomica 12x, Plumbum met 12x, Sepia 12x Thuja 12x, Valeriana 6x

Purpose

Inactive ingredients:

alcohol 20%, purified water.

Symptoms include apprehension, uneasiness, worry, dread.

These uses are based on traditional homeopathic practice. They have not been evauated by the FDA.

Dosage:

In general, 10 drops under the tongue 3 times daily. In acute conditions, 10 drops every 15 minutes. Children, one half the above dosage. For children 2 years and under, and for people nursing a baby or pregnant, seek the advice of a health professional before use.

DO NOT USE

IF BioE IMPRINTED SEAL ON NECK IS BROKEN

If symptoms worsen or persist for more than 7 days, consult a physician.

Keep out of the reach of children.

Package Labeling:

BioE Calm

BIOE CALM
aconitum napellus root, arsenic trioxide, sodium borate, activated charcoal, causticum, matricaria chamomilla, strychnos ignatii seed, lithium carbonate, sodium chloride, strychnos nux-vomica seed, lead, sepia officinalis juice, thuja occidentalis leafy twig, valerian liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:57293-4429
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACONITUM NAPELLUS ROOT (UNII: KPD2N7348X) (ACONITUM NAPELLUS ROOT - UNII:KPD2N7348X)	ACONITUM NAPELLUS ROOT	12 [hp_X] in 60 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	12 [hp_X] in 60 mL
SODIUM BORATE (UNII: 91MBZ8H3QO) (BORATE ION - UNII:44OAE30D22)	SODIUM BORATE	9 [hp_X] in 60 mL
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10)	ACTIVATED CHARCOAL	12 [hp_X] in 60 mL
CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU)	CAUSTICUM	6 [hp_X] in 60 mL
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ)	MATRICARIA CHAMOMILLA	6 [hp_X] in 60 mL
STRYCHNOS IGNATII SEED (UNII: 1NM3M2487K) (STRYCHNOS IGNATII SEED - UNII:1NM3M2487K)	STRYCHNOS IGNATII SEED	12 [hp_X] in 60 mL
LITHIUM CARBONATE (UNII: 2BMD2GNA4V) (LITHIUM CATION - UNII:8H8Z5UER66)	LITHIUM CARBONATE	12 [hp_X] in 60 mL
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)	SODIUM CHLORIDE	9 [hp_X] in 60 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	12 [hp_X] in 60 mL
LEAD (UNII: 2P299V784P) (LEAD - UNII:2P299V784P)	LEAD	12 [hp_X] in 60 mL
SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2)	SEPIA OFFICINALIS JUICE	12 [hp_X] in 60 mL
THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397)	THUJA OCCIDENTALIS LEAFY TWIG	12 [hp_X] in 60 mL
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW)	VALERIAN	6 [hp_X] in 60 mL

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:57293-4429-2	60 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	03/12/2018	07/31/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		03/12/2018	07/31/2021

Labeler - BioEnergetics, Inc. (102847014)

Registrant - BioEnergetics, Inc. (102847014)

Revised: 12/2021

Document Id: d34f840b-d8c8-461e-e053-2995a90aedc9

Set id: 78aa5103-0202-449d-a402-8b91a16d8032

Version: 3

Effective Time: 20211216

BioEnergetics, Inc.