Drug Facts

Drug Facts
SPL v13
SPL
SPL Set ID 863fb393-0af0-4ee1-8c78-b7ba3c4f2ba4
Routes
ORAL TOPICAL
Published
Effective Date 2015-09-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Actaea Spicata Root (10 [hp_X]) Aesculus Hippocastanum Flower Arnica Montana Bellis Perennis Bryonia Alba Root Oyster Shell Calcium Carbonate, Crude Fluoride Ion Causticum Black Cohosh Formic Acid Hypericum Perforatum Ledum Palustre Twig Lithium Cation Magnesium Cation Phosphorus Phytolacca Americana Root Pulsatilla Vulgaris Rhododendron Aureum Leaf Toxicodendron Pubescens Leaf Ruta Graveolens Flowering Top Salicylic Acid Sepia Officinalis Juice Sulfur Zinc
Inactive Ingredients
Potassium Sorbate Water Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2010-05-20

Description

 Actaea spicata HPUS, Aesculus hippocastanum HPUS, Arnica Montana HPUS, Bellis perennis HPUS, Bryonia HPUS, Calcarea carbonica HPUS, Calcarea fluorica HPUS, Causticum HPUS, Cimicifuga racemosa HPUS, Formicum acidum HPUS, Hypericum perforatum HPUS, Ledum palustre HPUS, Lithium carbonicum HPUS, Magnesia phosphorica HPUS, Phosphorus HPUS, Phytolacca decandra HPUS, Pulsatilla HPUS, Rhododendron chrysanthum HPUS, Rhus toxicodendron HPUS, Ruta graveolens HPUS, Salicylicum acidum HPUS, Sepia HPUS, Sulphur HPUS, Zincum metallicum HPUS Each active ingredient contains equal volumes of 10X, 20X, 30X and LM1 potencies. The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States. Product indications are based on Homeopathic Materia Medica.

Purpose

Actaea spicata HPUS.......................................................Lameness Aesculus hippocastanum HPUS........................................Numbness Arnica Montana HPUS......................................................Stiffness Bellis perennis HPUS.......................................................Soreness Bryonia HPUS.................................................................Headache Calcarea carbonica HPUS................................................Lower back pain Calcarea fluorica HPUS....................................................Back pain Causticum HPUS............................................................Sciatica Cimicifuga racemosa HPUS.............................................Rheumatism Formicum acidum HPUS..................................................Hip and thigh pain Hypericum perforatum HPUS............................................Neuralgia Ledum palustre HPUS......................................................Pain in head Lithium carbonicum HPUS................................................Pain in extremities Magnesia phosphorica HPUS...........................................Pain in ears Phosphorus HPUS...........................................................Neuritis Phytolacca decandra HPUS..............................................Shoulder pain Pulsatilla HPUS...............................................................Nerve injury Rhododendron chrysanthum HPUS....................................Inflammation Rhus toxicodendron HPUS................................................Lower back pain Ruta graveolens HPUS.....................................................Sprains Salicylicum acidum HPUS................................................Headaches Sepia HPUS....................................................................Stiffness in extremities Sulphur HPUS..................................................................Twitching Zincum metallicum HPUS..................................................Pain in eyes


Medication Information

Purpose

Actaea spicata HPUS.......................................................Lameness

Aesculus hippocastanum HPUS........................................Numbness

Arnica Montana HPUS......................................................Stiffness

Bellis perennis HPUS.......................................................Soreness

Bryonia HPUS.................................................................Headache

Calcarea carbonica HPUS................................................Lower back pain

Calcarea fluorica HPUS....................................................Back pain

Causticum HPUS............................................................Sciatica

Cimicifuga racemosa HPUS.............................................Rheumatism

Formicum acidum HPUS..................................................Hip and thigh pain

Hypericum perforatum HPUS............................................Neuralgia

Ledum palustre HPUS......................................................Pain in head

Lithium carbonicum HPUS................................................Pain in extremities

Magnesia phosphorica HPUS...........................................Pain in ears

Phosphorus HPUS...........................................................Neuritis

Phytolacca decandra HPUS..............................................Shoulder pain

Pulsatilla HPUS...............................................................Nerve injury

Rhododendron chrysanthum HPUS....................................Inflammation

Rhus toxicodendron HPUS................................................Lower back pain

Ruta graveolens HPUS.....................................................Sprains

Salicylicum acidum HPUS................................................Headaches

Sepia HPUS....................................................................Stiffness in extremities

Sulphur HPUS..................................................................Twitching

Zincum metallicum HPUS..................................................Pain in eyes

Description

  • 30-day supply
  • dropper included
  • Painazol is made without alcohol or sugar.  No gluten added.
Mftd for: HelloLife, Inc. 4460 44th St. SE Ste. C-600 Grand Rapids, MI 49512 FDA Pharmaceutical Establishment #1053442, #3009727070 www.painazol.com

Uses

For temporary relief of symptoms commonly associated with sciatica, such as:

  • pain
  • sensitivity
  • burning
  • tingling
  • weakness
  • numbness
Section 50565-1

Keep out of the reach of children.

Section 50566-9

Stop use and ask a doctor if symptoms persist or worsen.

Section 50567-7

When using this product, use only as directed.

Section 51945-4

NDC 49726-012-02



PAINAZOL TM

Liquid Pain Symptom Relief

For temporary relief of symptoms commonly associated with sciatica, such as:

  • pain
  • weakness
  • tingling
  • burning
  • sensitivity
  • numbness

2 FL OZ (59 mL)

Homeopathic (OTC) Medicine

Section 53414-9

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

Warnings

Ask a doctor before use if

  • you are taking any other medications
  • you have a medical condition



Directions

Dispense Painazol directly into mouth, or add recommended dosage to 8-12 oz purified (non-chlorinated water) and drink.

Dosage by Weight:

30-50 lbs (13.6-22.6 kg) 1/2 mL twice per day

50+ lbs (22.6+ kg) 1 mL twice per day. 

External Use:  If needed, apply to affected areas 2-6 times daily until symptoms improve.

Other Information


  • do not use if tamper seal is broken
  • store in a cool, dry place
  • product must not come in contact with metal
  • do not store next to electrical devices or appliances

Inactive Ingredients

citric acid, potassium sorbate, purified ionized mineral water

Questions Or Comments

You can email us at [email protected] or give us a call toll-free at 1.800.875.0850 Monday through Friday 9am-5pm ET

Active Ingredient (per Dose)
 Actaea spicata HPUS, Aesculus hippocastanum HPUS, Arnica Montana HPUS, Bellis perennis HPUS, Bryonia HPUS, Calcarea carbonica HPUS, Calcarea fluorica HPUS, Causticum HPUS, Cimicifuga racemosa HPUS, Formicum acidum HPUS, Hypericum perforatum HPUS, Ledum palustre HPUS, Lithium carbonicum HPUS, Magnesia phosphorica HPUS, Phosphorus HPUS, Phytolacca decandra HPUS, Pulsatilla HPUS, Rhododendron chrysanthum HPUS, Rhus toxicodendron HPUS, Ruta graveolens HPUS, Salicylicum acidum HPUS, Sepia HPUS, Sulphur HPUS, Zincum metallicum HPUS

Each active ingredient contains equal volumes of 10X, 20X, 30X and LM1 potencies. The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States. Product indications are based on Homeopathic Materia Medica.


Structured Label Content

Uses

For temporary relief of symptoms commonly associated with sciatica, such as:

  • pain
  • sensitivity
  • burning
  • tingling
  • weakness
  • numbness
Description (34089-3)

  • 30-day supply
  • dropper included
  • Painazol is made without alcohol or sugar.  No gluten added.
Mftd for: HelloLife, Inc. 4460 44th St. SE Ste. C-600 Grand Rapids, MI 49512 FDA Pharmaceutical Establishment #1053442, #3009727070 www.painazol.com

Section 50565-1 (50565-1)

Keep out of the reach of children.

Section 50566-9 (50566-9)

Stop use and ask a doctor if symptoms persist or worsen.

Section 50567-7 (50567-7)

When using this product, use only as directed.

Section 51945-4 (51945-4)

NDC 49726-012-02



PAINAZOL TM

Liquid Pain Symptom Relief

For temporary relief of symptoms commonly associated with sciatica, such as:

  • pain
  • weakness
  • tingling
  • burning
  • sensitivity
  • numbness

2 FL OZ (59 mL)

Homeopathic (OTC) Medicine

Section 53414-9 (53414-9)

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

Purpose

Actaea spicata HPUS.......................................................Lameness

Aesculus hippocastanum HPUS........................................Numbness

Arnica Montana HPUS......................................................Stiffness

Bellis perennis HPUS.......................................................Soreness

Bryonia HPUS.................................................................Headache

Calcarea carbonica HPUS................................................Lower back pain

Calcarea fluorica HPUS....................................................Back pain

Causticum HPUS............................................................Sciatica

Cimicifuga racemosa HPUS.............................................Rheumatism

Formicum acidum HPUS..................................................Hip and thigh pain

Hypericum perforatum HPUS............................................Neuralgia

Ledum palustre HPUS......................................................Pain in head

Lithium carbonicum HPUS................................................Pain in extremities

Magnesia phosphorica HPUS...........................................Pain in ears

Phosphorus HPUS...........................................................Neuritis

Phytolacca decandra HPUS..............................................Shoulder pain

Pulsatilla HPUS...............................................................Nerve injury

Rhododendron chrysanthum HPUS....................................Inflammation

Rhus toxicodendron HPUS................................................Lower back pain

Ruta graveolens HPUS.....................................................Sprains

Salicylicum acidum HPUS................................................Headaches

Sepia HPUS....................................................................Stiffness in extremities

Sulphur HPUS..................................................................Twitching

Zincum metallicum HPUS..................................................Pain in eyes

Warnings

Ask a doctor before use if

  • you are taking any other medications
  • you have a medical condition



Directions

Dispense Painazol directly into mouth, or add recommended dosage to 8-12 oz purified (non-chlorinated water) and drink.

Dosage by Weight:

30-50 lbs (13.6-22.6 kg) 1/2 mL twice per day

50+ lbs (22.6+ kg) 1 mL twice per day. 

External Use:  If needed, apply to affected areas 2-6 times daily until symptoms improve.

Other Information


  • do not use if tamper seal is broken
  • store in a cool, dry place
  • product must not come in contact with metal
  • do not store next to electrical devices or appliances

Inactive Ingredients (Inactive ingredients)

citric acid, potassium sorbate, purified ionized mineral water

Questions Or Comments (Questions or comments)

You can email us at [email protected] or give us a call toll-free at 1.800.875.0850 Monday through Friday 9am-5pm ET

Active Ingredient (per Dose) (Active Ingredient (per dose))
 Actaea spicata HPUS, Aesculus hippocastanum HPUS, Arnica Montana HPUS, Bellis perennis HPUS, Bryonia HPUS, Calcarea carbonica HPUS, Calcarea fluorica HPUS, Causticum HPUS, Cimicifuga racemosa HPUS, Formicum acidum HPUS, Hypericum perforatum HPUS, Ledum palustre HPUS, Lithium carbonicum HPUS, Magnesia phosphorica HPUS, Phosphorus HPUS, Phytolacca decandra HPUS, Pulsatilla HPUS, Rhododendron chrysanthum HPUS, Rhus toxicodendron HPUS, Ruta graveolens HPUS, Salicylicum acidum HPUS, Sepia HPUS, Sulphur HPUS, Zincum metallicum HPUS

Each active ingredient contains equal volumes of 10X, 20X, 30X and LM1 potencies. The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States. Product indications are based on Homeopathic Materia Medica.


Advanced Ingredient Data


Raw Label Data

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