Label: 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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

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.

Drug Label Information

Updated August 20, 2014

If you are a consumer or patient please visit this version.

  • 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.

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  • INACTIVE INGREDIENT

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

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  • 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.

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  • DOSAGE & ADMINISTRATION

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

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  • 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.

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children.

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  • OTHER SAFETY INFORMATION

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

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  • 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
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  • 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)
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