Painazol
FDA Label NDC 49726-012

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Hello Life, Inc. for the product Painazol (NDC 49726-012). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (per dose), purpose, uses, warnings, otc - when using, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.

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

Uses

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

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

Warnings

Ask a doctor before use if

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


Otc - When Using

When using this product, use only as directed.

Otc - Stop Use

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

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children.

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

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

Package Label.Principal Display Panel

NDC 49726-012-02


PAINAZOLTM

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

    Painazolcarton (Painazolcarton)

    Painazolcarton (Painazolcarton)

* Please review the disclaimer below.