Calloused
FDA Label NDC 57955-2311

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 Calloused (NDC 57955-2311). 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 activeingredients: Allium sativum, Anacardium orientale, Calendula officinalis, Capsicum annuum, Ceanothus americanus, Chamomilla, Chelidonium majus, Conium maculatum, Kali carbonicum, Lobelia cardinalis, Mancinella, Myristica sebifera, Pinus sylvestris, flos, Stigmata maidis, Sepia, Taraxacum officinale, Thea sinensis. Equal volumes of each ingredient in 10X, 30X, 100X, LM1, LM2, LM3, LM5 potencies.

Indications & Usage

Uses for temporary relief of: hard-heartedness, fear of losing control. indifference, coldness toward others.

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: 3 sprays 3 times per day.
  • Children 2 - 12: 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.

Otc - Purpose

Uses ​for temporary relief of:

  • hard-heartedness
  • fear of losing control
  • indifference
  • coldness toward others

Package Label.Principal Display Panel

Image Description (Calloused)

Image Description (Calloused)

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