Drug Facts:

Drug Facts:
SPL v3
SPL
SPL Set ID c34e0abf-02d8-4dee-a89b-3f61ab593dc3
Route
ORAL
Published
Effective Date 2022-02-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Baptisia Tinctoria Root (3 [hp_X]) Echinacea Angustifolia (6 [hp_X]) Goldenseal (12 [hp_X]) Phytolacca Americana Root Atropa Belladonna Oyster Shell Calcium Carbonate, Crude Matricaria Chamomilla Ferrosoferric Phosphate Mercurius Solubilis Pulsatilla Pratensis Whole
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2018-08-21

Description

(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.


Medication Information

Description

(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.

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.

Questions:

Dist. by Energique, Inc.

201 Apple Blvd

Woodbine, IA 51579   800.869.8078

Directions:

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist for more than 4 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

Indications:

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

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

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.

Inactive Ingredients:

Demineralized water, 20% Ethanol.

Package Label Display:

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

OTOTONE

1 fl. oz. (30 ml)

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.


Structured Label Content

Warnings: (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.

Questions: (QUESTIONS:)

Dist. by Energique, Inc.

201 Apple Blvd

Woodbine, IA 51579   800.869.8078

Directions: (DIRECTIONS:)

Adults and children 5 to 10 drops orally, 3 times daily or as otherwise directed by a health care professional. If symptoms persist for more than 4 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

Indications: (INDICATIONS:)

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

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

Active Ingredients: (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.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized water, 20% Ethanol.

Package Label Display: (PACKAGE LABEL DISPLAY:)

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

OTOTONE

1 fl. oz. (30 ml)

Keep Out of Reach of Children: (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.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)