BACK ACHE- berberis vulgaris root bark, lytta vesicatoria, rhododendron aureum leaf, toxicodendron pubescens leaf, sepia officinalis juice, solidago virgaurea flowering top 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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Back Ache Drops

Active Ingredients

Berberis vulg 6x,

Bryonia alba 6x,

Cantharis 6x,

Rhododendron chr 8x,

Solidago vigr 6x.

Purpose

Inactive ingredients:

alcohol 20%, purified water.

For relief from pain and discomfort of back ache

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:

Back Ache Drops

BACK ACHE
berberis vulgaris root bark, lytta vesicatoria, rhododendron aureum leaf, toxicodendron pubescens leaf, sepia officinalis juice, solidago virgaurea flowering top liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:57293-4414
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BERBERIS VULGARIS ROOT BARK (UNII: 1TH8Q20J0U) (BERBERIS VULGARIS ROOT BARK - UNII:1TH8Q20J0U)	BERBERIS VULGARIS ROOT BARK	6 [hp_X] in 60 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	6 [hp_X] in 60 mL
LYTTA VESICATORIA (UNII: 3Q034RO3BT) (LYTTA VESICATORIA - UNII:3Q034RO3BT)	LYTTA VESICATORIA	6 [hp_X] in 60 mL
RHODODENDRON AUREUM LEAF (UNII: IV92NQJ73U) (RHODODENDRON AUREUM LEAF - UNII:IV92NQJ73U)	RHODODENDRON AUREUM LEAF	8 [hp_X] in 60 mL
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	6 [hp_X] in 60 mL
SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2)	SEPIA OFFICINALIS JUICE	6 [hp_X] in 60 mL
SOLIDAGO VIRGAUREA FLOWERING TOP (UNII: 5405K23S50) (SOLIDAGO VIRGAUREA FLOWERING TOP - UNII:5405K23S50)	SOLIDAGO VIRGAUREA FLOWERING TOP	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:57293-4414-2	60 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	04/24/1991	07/31/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		04/24/1991	07/31/2021

Labeler - BioEnergetics, Inc. (102847014)

Registrant - BioEnergetics, Inc. (102847014)

Revised: 12/2021

Document Id: d350259d-862d-559b-e053-2a95a90a7ebf

Set id: 02f92be2-98a9-4bc4-89e9-6f1b665e7b8d

Version: 4

Effective Time: 20211216

BioEnergetics, Inc.