Hydration
FDA Label NDC 57955-0100

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 Hydration (NDC 57955-0100). 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, otc - purpose, inactive ingredient, warnings, otc - keep out of reach of children, dosage & administration, other safety information, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

HPUS active ingredients: Aloe socotrina, Apis mellifica, Avena sativa, Carbo vegetabilis, Equisetum hyemale, Gelsemium sempervirens, Pulsatilla, Selenium metallicum, Taraxacum officinale. Equal volumes of each ingredient in 10X, 30X, 100X, 1M, 1LM, 2LM, 3LM potencies.

Otc - Purpose

Uses​ for temporary relief of symptoms: lack of thirst, headache, sluggishness, frequent urination, fatigue, and dry skin and mouth.

Inactive Ingredient

Inactive Ingredients:

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

Warnings

Warning

  • Stop use and ask a 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: 3 sprays 3 times per day.
  • Children 2-12 years: 2 sprays 3 times per day.
  • Use additionally as needed, up to 6 times per day.

Other Safety Information

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

Indications & Usage

Uses for temporary relief of symptoms:

  • lack of thirst
  • headache
  • sluggishness
  • frequent urination
  • fatigue and dry skin and mouth

Package Label.Principal Display Panel

Image Description (Hydration)

Image Description (Hydration)

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