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  5. Label Information: Teething

FDA Label for Teething

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. INDICATIONS & USAGE
    3. INACTIVE INGREDIENT
    4. WARNINGS
    5. OTC - KEEP OUT OF REACH OF CHILDREN
    6. DOSAGE & ADMINISTRATION
    7. OTHER SAFETY INFORMATION
    8. OTC - PURPOSE
    9. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Teething Product Label

The following document was submitted to the FDA by the labeler of this product King Bio Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Drug Facts​__________________________________________________________________________________________________________

HPUS active ingredients: Agaricus muscarius, Belladonna, Calcarea carbonica, Calcarea phosphorica, Chamomilla, Ferrum phosphoricum, Kreosotum, Zincum metallicum. Equal volumes of each ingredient in 10X, 30X, 100X, 1M, 1LM, 2LM, 3LM potencies.


Indications & Usage



Uses for temporary relief of: teething pain, swelling gums, delayed teething, low grade fever, restlessness, heavy salivation, irritability, desire to be held constantly.


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, take only on advice of a healthcare professional.

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.
  • Adults 12 and up: 3 sprays 3 times per day
  • ​Children 2-12: 2 sprays 3 times per day
  • Children 2 mo-2yr: 1 spray 3 times per day

Other Safety Information



Tamper resistant for your protection. Use only if safety seal is intact. This product has not been clinically tested.


Otc - Purpose



Uses ​for temporary relief of:

  • teething pain
  • swelling gums
  • delayed teething
  • low grade fever
  • restlessness
  • heavy salivation
  • irritability
  • desire to be held constantly

Package Label.Principal Display Panel



image description - Teething

image description - Teething


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