Ear Ringing Symptom Formula
FDA Label NDC 57955-7295

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 Ear Ringing Symptom Formula (NDC 57955-7295). 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, warnings, otc - keep out of reach of children, dosage & administration, other safety information, inactive ingredient, 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

____________________________________________________________________________________________________________

Equal volumes of each ingredient in 10X, 30X, and LM1 potencies.

HPUS active ingredients: Arnica montana, Calcarea carbonica, Chenopodium anthelminticum, Chininum salicylicum, Cimicifuga racemosa, Coffea tosta, Kali iodatum, Kalmia latifolia, Magnesia carbonica, Manganum aceticum, Manganum carbonicum, Mercurius vivus, Natrum salicylicum, Salicylicum acidum, Thiosinaminum, Thyroidinum.

Indications & Usage

Uses for symptomic relief of ear sounds:

  • buzzing, roaring, ringing, and whistling
  • sensitivity to noise

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

Directions:

  • Initially, depress pump until primed.
  • Spray one dose directly into mouth.
  • Adults: 3 sprays 3 times per day.
  • Children 6-12 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 is intended to complement, not replace, standard medical care.

Inactive Ingredient

Inactive Ingredients: Bio-Energetically Enhanced pure water, citric acid and potassium sorbate.

Otc - Purpose

Drug Facts __________________________________________________________________________________________________________________ HPUS active ingredients                                                                    Purpose

Equal volumes of each ingredient in 10X, 30X, and LM1 potencies.

Arnica montana.....................................................................noise in ear

Calcarea carbonica.................................................................humming in ear

Chenopodium anthelminticum..................................................vertigo

Chininum salicylicum..............................................................tinnitus

Cimicifuga racemosa...............................................................sensitivity to noise

Coffea tosta...........................................................................sensitivity to sound

Kali iodatum..........................................................................noises in ear

Kalmia latifolia.......................................................................vertigo

Magnesia carbonica.................................................................tinnitus

Manganum aceticum...............................................................whistling in ear

Manganum carbonicum...........................................................buzzing and rumbling in ears

Mercurius vivus......................................................................ringing in ears

Natrum salicylicum.................................................................noises in ears

Salicylicum acidum.................................................................roaring and ringing in ears

Thiosinaminum......................................................................tinnitus

Thyroidinum..........................................................................vertigo

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