Earwa 2428l

Earwa 2428l
SPL v3
SPL
SPL Set ID 9302b838-6003-ba6a-e053-2995a90aedd3
Route
ORAL
Published
Effective Date 2019-01-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Micrurus Corallinus Venom (30 [hp_X]) Aluminum Oxide (15 [hp_X]) Activated Charcoal Causticum Conium Maculatum Flowering Top Graphite Dichromate Ion Potassium Cation Lachesis Muta Venom Lycopodium Clavatum Spore Liquid Petroleum Pulsatilla Vulgaris Schoenocaulon Officinale Seed Sepia Officinalis Juice Silicon Dioxide Spongia Officinalis Skeleton, Roasted Verbascum Thapsus Viola Odorata
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2019-01-31 Until 2019-08-01

Description

Formulated for associated symptoms such as dryness, itching, hearing difficulties and excess wax accumulation.

Purpose

Formulated for associated symptoms such as dryness, itching, hearing difficulties and excess wax accumulation.


Medication Information

Purpose

Formulated for associated symptoms such as dryness, itching, hearing difficulties and excess wax accumulation.

Description

Formulated for associated symptoms such as dryness, itching, hearing difficulties and excess wax accumulation.

Package Label

Warnings Section

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

Questions Section

newtonlabs.net - Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

Otc Purpose Section

Formulated for associated symptoms such as dryness, itching, hearing difficulties and excess wax accumulation.

Inactive Ingredient Section

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%.

Indications & Usage Section

Formulated for associated symptoms such as dryness, itching, hearing difficulties and excess wax accumulation.

Dosage & Administration Section

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) as needed or as directed by a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

Otc Active Ingredient Section

Equal parats of Alumina 15x, Carbo veg. 15x, Causticum 15x, Conium 15x, Graphites 15x, Kali bic. 15x, Kali mur. 15x, Lachesis 15x, Lycopodium 15x, Petroleum 15x, Pulsatilla 15x, Sabadilla 15x, Sepia 15x, Silicea 15x, Spongia 15x, Verbascum 15x, Viola odorata 15x, Elaps 30x.

Otc Pregnancy Or Breast Feeding Section

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

Otc Keep Out of Reach of Children Section

Keep out of reach of children.


Structured Label Content

Package Label (PACKAGE LABEL)

Warnings Section (WARNINGS SECTION)

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

Questions Section (QUESTIONS SECTION)

newtonlabs.net - Questions? 800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

Otc Purpose Section (OTC - PURPOSE SECTION)

Formulated for associated symptoms such as dryness, itching, hearing difficulties and excess wax accumulation.

Inactive Ingredient Section (INACTIVE INGREDIENT SECTION)

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%.

Indications & Usage Section (INDICATIONS & USAGE SECTION)

Formulated for associated symptoms such as dryness, itching, hearing difficulties and excess wax accumulation.

Dosage & Administration Section (DOSAGE & ADMINISTRATION SECTION)

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) as needed or as directed by a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

Otc Active Ingredient Section (OTC - ACTIVE INGREDIENT SECTION)

Equal parats of Alumina 15x, Carbo veg. 15x, Causticum 15x, Conium 15x, Graphites 15x, Kali bic. 15x, Kali mur. 15x, Lachesis 15x, Lycopodium 15x, Petroleum 15x, Pulsatilla 15x, Sabadilla 15x, Sepia 15x, Silicea 15x, Spongia 15x, Verbascum 15x, Viola odorata 15x, Elaps 30x.

Otc Pregnancy Or Breast Feeding Section (OTC - PREGNANCY OR BREAST FEEDING SECTION)

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

Otc Keep Out of Reach of Children Section (OTC - KEEP OUT OF REACH OF CHILDREN SECTION)

Keep out of reach of children.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)