Newborn Tonic
FDA Label NDC 57955-5114

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 Newborn Tonic (NDC 57955-5114). 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: Aconitum napellus, Bovista, Bryonia, Chamomilla, Cinchona officinalis, Lupulinum, Mercurius vivus, Myrica cerifera, Natrum sulphuricum, Phosphorus, Sepia. Equal volumes of each ingredient in 10X, 30X, LM1 potencies.

Indications & Usage

Uses for temporary relief of symptoms: skin rashes, skin discoloration, minor skin problems.

Inactive Ingredient

Inactive Ingredients:

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

Warnings

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

Dosage & Administration

  • 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.
  • Ages 2 months-2 years - 1 spray 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 symptoms:

  • skin rashes
  • skin discoloration
  • minor skin problems

Package Label.Principal Display Panel

Image Description (Newborn)

Image Description (Newborn)

* Please review the disclaimer below.