Drug Facts:

Drug Facts:
SPL v3
SPL
SPL Set ID 76c6b494-43d1-4508-bea4-4f9026b4a5fa
Route
ORAL
Published
Effective Date 2021-09-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Atropa Belladonna Whole (30 [hp_X]) Conium Maculatum Flowering Top (30 [hp_C]) Solanum Dulcamara Top Ferrosoferric Phosphate Calcium Sulfide Dichromate Ion Mercurius Solubilis Pulsatilla Pratensis Whole Silicon Dioxide Matricaria Chamomilla
Inactive Ingredients
Water Alcohol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2019-10-03

Description

(in each drop): 10% of Belladonna 30X, Chamomilla 30C, Conium Maculatum 30X, Dulcamara 30X, Ferrum Phosphoricum 30X, Hepar Sulphuris Calcareum 30X, Kali Bichromicum 30X, Mercurius Solubilis 30X, Pulsatilla 30X, Silicea 30X.

Indications and Usage

May temporarily relieve ear pain and swelling.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.


Medication Information

Indications and Usage

May temporarily relieve ear pain and swelling.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Description

(in each drop): 10% of Belladonna 30X, Chamomilla 30C, Conium Maculatum 30X, Dulcamara 30X, Ferrum Phosphoricum 30X, Hepar Sulphuris Calcareum 30X, Kali Bichromicum 30X, Mercurius Solubilis 30X, Pulsatilla 30X, Silicea 30X.

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 ear pain and swelling.**

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

Active Ingredients:

(in each drop): 10% of Belladonna 30X, Chamomilla 30C, Conium Maculatum 30X, Dulcamara 30X, Ferrum Phosphoricum 30X, Hepar Sulphuris Calcareum 30X, Kali Bichromicum 30X, Mercurius Solubilis 30X, Pulsatilla 30X, Silicea 30X.

Inactive Ingredients:

Demineralized water, 20% Ethanol.

Indications and Usage:

May temporarily relieve ear pain and swelling.**

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

Package Label Display:

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

OTOFLAM HP

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 ear pain and swelling.**

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

Active Ingredients: (ACTIVE INGREDIENTS:)

(in each drop): 10% of Belladonna 30X, Chamomilla 30C, Conium Maculatum 30X, Dulcamara 30X, Ferrum Phosphoricum 30X, Hepar Sulphuris Calcareum 30X, Kali Bichromicum 30X, Mercurius Solubilis 30X, Pulsatilla 30X, Silicea 30X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Demineralized water, 20% Ethanol.

Indications and Usage: (INDICATIONS AND USAGE:)

May temporarily relieve ear pain and swelling.**

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

Package Label Display: (PACKAGE LABEL DISPLAY:)

ENERGIQUE

SINCE 1987

HOMEOPATHIC REMEDY

OTOFLAM HP

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

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