PAINDEFENSE- actaea spicata, aesculus hippocastanum, arnica montana, bellis perennis, bryonia, calcarea carbonica, calcarea fluorica, causticum, cimicifuga racemosa, formicum acidum, hypericum perforatum, lemna minor, lithium carbonicum, magnesia phosphorica, phosphorus, phytolacca decandra, pulsatilla, rhododendron chrysanthum, rhus toxicodendron, ruta graveolens, salicylicum acidum, sepia, zincum metallicum liquid

PainDefense by

Drug Labeling and Warnings

PainDefense by is a Homeopathic medication manufactured, distributed, or labeled by PharmWest Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients: Official HPUS: Actaea spicata, Aesculus hippocastanum, Arnica montana, Bellis perennis, Bryonia, Calcarea carbonica, Calcarea fluorica, Causticum, Cimicifuga racemosa, Formicum acidum, Hypericum perforatum, Lemna minor, Lithium carbonicum, Magnesia phosphorica, Phosphorus, Phytolacca decandra, Pulsatilla, Rhododendron chrysanthum, Rhus toxicodendron, Ruta graveolens, Salicylicum acidum, Sepia, Zincum metallicum. Equal volumes of each ingredient in 10X, 30X, LM1 potencies.

INACTIVE INGREDIENT

Inactive ingredients: Citric acid, potassium sorbate, pure water base.

INDICATIONS & USAGE

Indications for use: For temporary relief from arthritis pain, muscle aches, stiff and swollen joints, chronic pain, back pain, sprain and joint injuries, aching limbs, rheumatic pain.

DOSAGE & ADMINISTRATION

Directions: Spray directly into mouth. Use 3 times daily. Adult dose is 3 pump sprays and childrens dose is 2 pump sprays.

WARNINGS

Warnings: If symptoms persist or worsen, stop usage and consult a physician. If pregnant or breast-feeding, take only upon advice of a healthcare professional.

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children.

OTHER SAFETY INFORMATION

Tamper resistant for your protection. Use only if safety seal is intact.

PURPOSE

Indications: For temporary relief from:

• arthritis pain
• muscle aches
• stiff and swollen joints
• chronic pain
• back pain
• sprain and joint injuries
• aching limbs
• rheumatic pain

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PAINDEFENSE 
actaea spicata, aesculus hippocastanum, arnica montana, bellis perennis, bryonia, calcarea carbonica, calcarea fluorica, causticum, cimicifuga racemosa, formicum acidum, hypericum perforatum, lemna minor, lithium carbonicum, magnesia phosphorica, phosphorus, phytolacca decandra, pulsatilla, rhododendron chrysanthum, rhus toxicodendron, ruta graveolens, salicylicum acidum, sepia, zincum metallicum liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50441-0001
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACTAEA SPICATA ROOT (UNII: 3FU86L9OS0) (ACTAEA SPICATA ROOT - UNII:3FU86L9OS0)	ACTAEA SPICATA ROOT	10 [hp_X]  in 59 mL
HORSE CHESTNUT (UNII: 3C18L6RJAZ) (HORSE CHESTNUT - UNII:3C18L6RJAZ)	HORSE CHESTNUT	10 [hp_X]  in 59 mL
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	10 [hp_X]  in 59 mL
BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY)	BELLIS PERENNIS	10 [hp_X]  in 59 mL
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	10 [hp_X]  in 59 mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I)	OYSTER SHELL CALCIUM CARBONATE, CRUDE	10 [hp_X]  in 59 mL
CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O)	CALCIUM FLUORIDE	10 [hp_X]  in 59 mL
CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU)	CAUSTICUM	10 [hp_X]  in 59 mL
BLACK COHOSH (UNII: K73E24S6X9) (BLACK COHOSH - UNII:K73E24S6X9)	BLACK COHOSH	10 [hp_X]  in 59 mL
FORMIC ACID (UNII: 0YIW783RG1) (FORMIC ACID - UNII:0YIW783RG1)	FORMIC ACID	10 [hp_X]  in 59 mL
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM	10 [hp_X]  in 59 mL
LEMNA MINOR (UNII: 621HHM46SV) (LEMNA MINOR - UNII:621HHM46SV)	LEMNA MINOR	10 [hp_X]  in 59 mL
LITHIUM CARBONATE (UNII: 2BMD2GNA4V) (LITHIUM CATION - UNII:8H8Z5UER66)	LITHIUM CARBONATE	10 [hp_X]  in 59 mL
MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (UNII: HF539G9L3Q) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE	10 [hp_X]  in 59 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	10 [hp_X]  in 59 mL
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG)	PHYTOLACCA AMERICANA ROOT	10 [hp_X]  in 59 mL
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	10 [hp_X]  in 59 mL
RHODODENDRON AUREUM LEAF (UNII: IV92NQJ73U) (RHODODENDRON AUREUM LEAF - UNII:IV92NQJ73U)	RHODODENDRON AUREUM LEAF	10 [hp_X]  in 59 mL
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	10 [hp_X]  in 59 mL
RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S)	RUTA GRAVEOLENS FLOWERING TOP	10 [hp_X]  in 59 mL
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	10 [hp_X]  in 59 mL
SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2)	SEPIA OFFICINALIS JUICE	10 [hp_X]  in 59 mL
ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS)	ZINC	10 [hp_X]  in 59 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50441-0001-2	59 mL in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		08/06/2013

Labeler - PharmWest Inc. (010587579)

Registrant - PharmWest Inc. (010587579)