Teething
FDA Label NDC 57955-5018

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 Teething (NDC 57955-5018). 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 ingredients, inactive ingredient, purpose, dosage and administration, warnings, otc - keep out of reach of children, indications and usage, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Official HPUS: Agaricus muscarius, Belladonna, Calcarea carbonica, Calcarea phosphorica, Chamomilla, Ferrum phosphoricum, Kreosotum and Zincum metallicum.

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Inactive Ingredient

Equal volumes of each ingredient in a Bio-Energetically Enhanced pure water base: 10X, 30X, and LM1 potencies.

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Purpose

Uses for temporary relief of teething pain

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

Directions: Initially, depress pump until primed. Hold close to mouth and spray directly into mouth. Use 3 times daily. Use additionally as needed.

Adult Dose 3 pump sprays

Children 2-12 years 2 pump sprays

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Warnings

If symptoms persist or worsen, consult a physician. If pregnant or nursing, take only on advice of a healthcare professional. Keep out of reach of children.

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

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Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

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Indications And Usage

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

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Package Label.Principal Display Panel

Image Of Label (Teething)

Image Of Label (Teething)

King Bio Inc.

3 Westside Drive

Asheville, NC 28806

Questions? Call 800.543.3245

www.kingbio.com

Safe and Natural

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