COMBINATION REMEDY 37 - LOW BACK PAIN- arnica montana, bryonia alba, calcarea fluorica, cobaltum metallicum, gnaphalium polycephalum 6x, hypericum perforatum, rhus toxicodendron, ruta graveolens solution/ drops

Combination Remedy 37 - Low Back Pain by

Drug Labeling and Warnings

Combination Remedy 37 - Low Back Pain by is a Homeopathic medication manufactured, distributed, or labeled by Warsan Homoeopathic Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WARNINGS

Stop use and ask doctor if symptoms worsen or persist longer than 7 days.

If pregnant or breast-feeding, ask health professional before use.

Do not use if tamper evident seal is missing or broken.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

ACTIVE INGREDIENT

Agaricus Muscarius 6X

Arnica Montana 1X

Bryonia Alba 6X

Calcarea Fluorica 6X

Cobaltum Metallicum 6X

Gnaphalium Polycephalum 6X

Hypericum Perforatum 1X

Rhus Toxicodendron 1X

Ruta Graveolens 6X

PURPOSE

Temporary relief from lower back pain, pain that starts in lower back and goes down in leg(s)..

INACTIVE INGREDIENT

Purified Water

Alcohol

DOSAGE & ADMINISTRATION

Adults 18 years and older: Take 10-15 drops in half cup of water 3 times a day.

INDICATIONS & USAGE

Temporary relief from lower back pain, pain that starts in lower back and goes down in leg(s).

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COMBINATION REMEDY 37 - LOW BACK PAIN 
arnica montana, bryonia alba, calcarea fluorica, cobaltum metallicum, gnaphalium polycephalum 6x, hypericum perforatum, rhus toxicodendron, ruta graveolens solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69008-4037
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	6 [hp_X]  in 1 mL
CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O)	CALCIUM FLUORIDE	6 [hp_X]  in 1 mL
AMANITA MUSCARIA FRUITING BODY (UNII: DIF093I037) (AMANITA MUSCARIA FRUITING BODY - UNII:DIF093I037)	AMANITA MUSCARIA FRUITING BODY	6 [hp_X]  in 1 mL
PSEUDOGNAPHALIUM OBTUSIFOLIUM (UNII: 36XQ854NWW) (PSEUDOGNAPHALIUM OBTUSIFOLIUM - UNII:36XQ854NWW)	PSEUDOGNAPHALIUM OBTUSIFOLIUM	6 [hp_X]  in 1 mL
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM	1 [hp_X]  in 1 mL
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	1 [hp_X]  in 1 mL
COBALT (UNII: 3G0H8C9362) (COBALT - UNII:3G0H8C9362)	COBALT	6 [hp_X]  in 1 mL
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	1 [hp_X]  in 1 mL
RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S)	RUTA GRAVEOLENS FLOWERING TOP	6 [hp_X]  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69008-4037-1	20 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	11/16/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		11/15/2017

Labeler - Warsan Homoeopathic Laboratories (645579772)

Registrant - Warsan Homoeopathic Laboratories (645579772)

Establishment
Name	Address	ID/FEI	Business Operations
Warsan Homoeopathic Laboratories		645579772	manufacture(69008-4037) , pack(69008-4037) , label(69008-4037)