Baby Teething
FDA Label NDC 57955-0467

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 Baby Teething (NDC 57955-0467). 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 hpus active ingredients, purpose, uses, directions, warnings, otc - keep out of reach of children, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Hpus Active Ingredients

Agaicus muscarius, Calcarea carbonica, Calcarea fluorica, Calcarea phosphorica, Chamomilla, Ferrum phosphoricum, Hepar sulphuris calcareum, Magnesia phosphorica, Phytolacca decandra, Podophyllum peltatum, Rheum, Zincum metallicum

Equal volumes of each in 30X, 60X, and 1LM potencies.

Purpose

HPUS Ingredient:                                 Purpose:

Agaicus muscarius...............................irritated gums

Calcarea carbonica...............................sleeplessness, difficult, delayed teething

Calcarea fluorica..................................toothache, vomiting in infants, supports dental development

Calcarea phosphorica............................discomforts from teething

Chamomilla..........................................desire to be held constantly

Ferrum phosphoricum............................fever-like disturbaces

Hepar sulphuris calcareum......................overly sensitive

Magnesia phosphorica............................complaints of teething

Phytolacca decandra...............................excess saliva, teething children, clenched teeth

Podophyllum peltatum............................drooling, difficult dentition, fussiness, restlessness

Rheum.................................................increased saliva, difficult teething, restlessness, irritability

Zincum metallicum.................................difficult teething, irritability

Uses

for temporary relief of: 

  • tething pain
  • irritated gums
  • delayed teething
  • fever-like disturbances
  • restlessness
  • heavy salivation and drooling
  • irritability
  • desire to be held constantly

Directions

  • Initially, depress pump until primed.
  • Spray one dose directly into mouth

    • Under 3 months: Consult a licensed healthcare professional before using

    3 months to 2 years: 1 spray every 15 minutes. up to 4 doses, then hourly until relieved

    2 to 6 years: 2 sprays every 15 minutes, up to 4 doses, then hourly until relieved

Warnings

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

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children

Other Information

  • This product is intended to compliment, not replace, standard medical care.
  • Tamper resistant for your protection. Use only if safety seal is intact.

Inactive Ingredients

Bio-Energetically Enhanced pure water, Carya ovata bark extract (hickory), citrus extract, Lonicer japonica (honeysuckle), polylysine (natural ferment), steviol glycosides (stevia)

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