PainDefense: Homeopathic Product Information

PAINDEFENSE- actaea spicata root, horse chestnut, arnica montana, bellis perennis, bryonia alba root, oyster shell calcium carbonate, crude, calcium fluoride, causticum, black cohosh, formic acid, hypericum perforatum, lemna minor, lithium carbonate, magnesium phosphate, dibasic trihydrate, phosphorus, phytolacca americana root, pulsatilla vulgaris, rhododendron aureum leaf, toxicodendron pubescens leaf, ruta graveolens flowering top, salicylic acid, sepia officinalis juice and zinc liquid
PharmWest 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.

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

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.

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

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 the reach of children.

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

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

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 DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACTAEA SPICATA ROOT (ACTAEA SPICATA ROOT) ACTAEA SPICATA ROOT 10 [hp_X] in 59 mL HORSE CHESTNUT (HORSE CHESTNUT) HORSE CHESTNUT 10 [hp_X] in 59 mL ARNICA MONTANA (ARNICA MONTANA) ARNICA MONTANA 10 [hp_X] in 59 mL BELLIS PERENNIS (BELLIS PERENNIS) BELLIS PERENNIS 10 [hp_X] in 59 mL BRYONIA ALBA ROOT (BRYONIA ALBA ROOT) BRYONIA ALBA ROOT 10 [hp_X] in 59 mL OYSTER SHELL CALCIUM CARBONATE, CRUDE (OYSTER SHELL CALCIUM CARBONATE, CRUDE) OYSTER SHELL CALCIUM CARBONATE, CRUDE 10 [hp_X] in 59 mL CALCIUM FLUORIDE (FLUORIDE ION) CALCIUM FLUORIDE 10 [hp_X] in 59 mL CAUSTICUM (CAUSTICUM) CAUSTICUM 10 [hp_X] in 59 mL BLACK COHOSH (BLACK COHOSH) BLACK COHOSH 10 [hp_X] in 59 mL FORMIC ACID (FORMIC ACID) FORMIC ACID 10 [hp_X] in 59 mL HYPERICUM PERFORATUM (HYPERICUM PERFORATUM) HYPERICUM PERFORATUM 10 [hp_X] in 59 mL LEMNA MINOR (LEMNA MINOR) LEMNA MINOR 10 [hp_X] in 59 mL LITHIUM CARBONATE (LITHIUM CATION) LITHIUM CARBONATE 10 [hp_X] in 59 mL MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE (MAGNESIUM CATION) MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE 10 [hp_X] in 59 mL PHOSPHORUS (PHOSPHORUS) PHOSPHORUS 10 [hp_X] in 59 mL PHYTOLACCA AMERICANA ROOT (PHYTOLACCA AMERICANA ROOT) PHYTOLACCA AMERICANA ROOT 10 [hp_X] in 59 mL PULSATILLA VULGARIS (PULSATILLA VULGARIS) PULSATILLA VULGARIS 10 [hp_X] in 59 mL RHODODENDRON AUREUM LEAF (RHODODENDRON AUREUM LEAF) RHODODENDRON AUREUM LEAF 10 [hp_X] in 59 mL TOXICODENDRON PUBESCENS LEAF (TOXICODENDRON PUBESCENS LEAF) TOXICODENDRON PUBESCENS LEAF 10 [hp_X] in 59 mL RUTA GRAVEOLENS FLOWERING TOP (RUTA GRAVEOLENS FLOWERING TOP) RUTA GRAVEOLENS FLOWERING TOP 10 [hp_X] in 59 mL SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 10 [hp_X] in 59 mL SEPIA OFFICINALIS JUICE (SEPIA OFFICINALIS JUICE) SEPIA OFFICINALIS JUICE 10 [hp_X] in 59 mL ZINC (ZINC) ZINC 10 [hp_X] in 59 mL

Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE POTASSIUM SORBATE WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:50441-0001-2 59 mL in 1 BOTTLE, SPRAY None

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)

Revised: 08/2014 PharmWest Inc.