Ototone Liquid
FDA Label NDC 44911-0467

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Energique, Inc. for the product Ototone (NDC 44911-0467). 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:, indications:, warnings:, keep out of reach of children:, directions:, inactive ingredients:, questions:, package label display:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients:

(in each drop): 12.48% of Belladonna 12X, Calcarea Carbonica 12X, Chamomilla 12X, Ferrum Phosphoricum 12X, Hydrastis Canadensis 6X, Mercurius Solubilis 12X, Phytolacca Decandra 6X, Pulsatilla (Pratensis) 12X; 0.10% of Baptisia Tinctoria 3X, Echinacea Angustifolia 3X.

Indications:

May temporarily relieve mild ear disorders with soreness, sticking pain in ear, minor swelling of the ear with redness.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

May temporarily relieve mild ear disorders with soreness, sticking pain in ear, minor swelling of the ear with redness.**

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Warnings:

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Do not use if tamper evident seal is broken or missing. Store in a cool, dry place.

Keep Out Of Reach Of Children:

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions:

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist, consult your health care professional. Consult a physician for use in children under 12 years of age.

Inactive Ingredients:

Demineralized water, 20% Ethanol.

Questions:

Dist. by Energique, Inc.

201 Apple Blvd

Woodbine, IA 51579   800.869.8078

Package Label Display:

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

OTOTONE

1 fl. oz. (30 ml)

* Please review the disclaimer below.