Paindefense
FDA Label NDC 50441-0001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pharmwest Inc. for the product Paindefense (NDC 50441-0001). 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 otc - active ingredient, inactive ingredient, indications & usage, dosage & administration, warnings, otc - keep out of reach of children, other safety information, otc - purpose, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - 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.

Otc - 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.

Otc - 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

Package Label.Principal Display Panel

Image Description (Paindefense)

Image Description (Paindefense)

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