BACK - citrullus colocynthis fruit pulp and pseudognaphalium obtusifolium and ammonium chloride and gelsemium sempervirens root and toxicodendron pubescens leaf and arsenic trioxide and matricaria recutita and tablet
MediNatura 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 Tablet

KEEP OUT OF REACH OF CHILDREN

Keep this and all medications out of the reach of children.

INDICATIONS AND USAGE

For the temporary relief of:

Lower Back Pain
Leg and Hip Pain
Neuralgia

WARNINGS

If symptoms persist or worse, a physician should be consulted. As with any drug, if you are pregnant or nursing a baby, seek the advise of a health care professional before using this product.

DOSAGE AND ADMINISTRATION

Adults and Children above 6 years: 1 tablet sublingually or dissolved completely in mouth 3 times daily or as directed by a physician. Infants and children 1/2 the adult dosage.

ACTIVE INGREDIENT

Each 300mg tablet contains as active ingredients; Coloncythis 5X, Gnaphallium polycephalum 5X, Ammonium murlaticum 6X, Gelsenium sempervirens 6X, Rhus toxicodendron 8x, Arsensicum album 10X, Chamomilla 10X 42.86 mg each.

INACTIVE INGREDIENT

Inactive ingredients: Lactose, Magnesium Sterate

PURPOSE

Lower back pain, Leg and hip pain, neuralgia

BACK
citrullus colocynthis fruit pulp and pseudognaphalium obtusifolium and ammonium chloride and gelsemium sempervirens root and toxicodendron pubescens leaf and arsenic trioxide and matricaria recutita and tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50114-4262
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CITRULLUS COLOCYNTHIS FRUIT PULP (UNII: 23H32AOH17) (CITRULLUS COLOCYNTHIS FRUIT PULP - UNII:23H32AOH17)	CITRULLUS COLOCYNTHIS FRUIT PULP	5 [hp_X]
PSEUDOGNAPHALIUM OBTUSIFOLIUM (UNII: 36XQ854NWW) (PSEUDOGNAPHALIUM OBTUSIFOLIUM - UNII:36XQ854NWW)	PSEUDOGNAPHALIUM OBTUSIFOLIUM	5 [hp_X]
AMMONIUM CHLORIDE (UNII: 01Q9PC255D) (AMMONIUM CATION - UNII:54S68520I4)	AMMONIUM CATION	6 [hp_X]
GELSEMIUM SEMPERVIRENS ROOT (UNII: 639KR60Q1Q) (GELSEMIUM SEMPERVIRENS ROOT - UNII:639KR60Q1Q)	GELSEMIUM SEMPERVIRENS ROOT	6 [hp_X]
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	8 [hp_X]
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	10 [hp_X]
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ)	MATRICARIA RECUTITA	10 [hp_X]

Ingredient Name	Strength
Inactive Ingredients
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)

Product Characteristics
Color	white	Score	no score
Shape	ROUND (Tablet)	Size	9mm
Flavor		Imprint Code	BHI;O;M
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50114-4262-2	100 in 1 BOTTLE; Type 0: Not a Combination Product	08/30/2007	09/30/2014

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		08/30/2007	09/30/2014

Labeler - MediNatura Inc. (102783016)

Name	Address	ID/FEI	Business Operations
Establishment
MediNatura Inc.		102783016	manufacture(50114-4262)

Revised: 3/2017

Document Id: bee97402-2d93-4ad8-95cb-33971b952f21

Set id: 2d76685d-ef4c-4880-945b-72c04644173a

Version: 2

Effective Time: 20170321

MediNatura Inc.