Tmj / Jaw Formula
FDA Label NDC 57955-5032

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by King Bio Inc. for the product Tmj / Jaw Formula (NDC 57955-5032). 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, indications & usage, inactive ingredient, warnings, otc - keep out of reach of children, dosage & administration, 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

Drug Facts​__________________________________________________________________________________________________________

HPUS active ingredients: Baptisia tinctoria, Calcarea fluorica, Causticum, Hepar sulphuris calcareum, Hypericum perforatum, Ignatia amara, Kalmia latifolia, Nux vomica, Phytolacca decandra, Rhus toxicodendron, Sanguinaria canadensis, Symphytum officinale. Equal volumes of each ingredient in 10X, 30X, and LM1 potencies.

Indications & Usage

Uses ​for temporary relief of: facial pains of the jaw, facial neuralgia, rigid jaw muscles, inflammation in the jaw, clenching of the jaw, cracking sounds.​

Inactive Ingredient

Inactive Ingredients:

Bio-Energetically Enhanced™ pure water, citric acid and potassium sorbate.

Warnings

Warnings

  • Stop use and ask your doctor if symptoms persist or worsen.
  • If pregnant or breast-feeding, ask a healthcare professional before ues.

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children.

Dosage & Administration

Directions

  • Initially, depress pump until primed.
  • Spray one dose directly into mouth.
  • Ages 12 and up: 3 sprays 3 times per day.
  • Ages 2-12: 2 sprays 3 times per day

Other Safety Information

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

Otc - Purpose

Uses ​for temporary relief of:

  • facial pains of the jaw
  • facial neuralgia
  • rigid jaw muscles
  • inflammation in the jaw
  • clenching of the jaw
  • cracking sounds

* Please review the disclaimer below.