Eye 2434l

Eye 2434l
SPL v3
SPL
SPL Set ID 924e15f1-92af-7fc9-e053-2995a90a1fcc
Route
ORAL
Published
Effective Date 2019-01-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aconitum Napellus (15 [hp_X]) Onion (6 [hp_X]) Arsenic Cation (3+) Bryonia Alba Root Calendula Officinalis Flowering Top Chelidonium Majus Jacobaea Maritima Euphrasia Stricta Graphite Lycopodium Clavatum Spore Mercuric Cation Strychnos Nux-vomica Seed Phosphorus Phytolacca Americana Root Pulsatilla Vulgaris Toxicodendron Pubescens Leaf Sulfur Echinacea, Unspecified Picric Acid
Inactive Ingredients
Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2019-01-31 Until 2019-09-02

Description

Formulated for associated symptoms such as eye strain, itching, pressure, redness, styes, swelling, twitching and sensitivity.

Purpose

Formulated for associated symptoms such as eye strain, itching, pressure, redness, styes, swelling, twitching and sensitivity.


Medication Information

Purpose

Formulated for associated symptoms such as eye strain, itching, pressure, redness, styes, swelling, twitching and sensitivity.

Description

Formulated for associated symptoms such as eye strain, itching, pressure, redness, styes, swelling, twitching and sensitivity.

Package Label

Warnings Section

WARNINGS: Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen 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 eye strain, itching, pressure, redness, styes, swelling, twitching and sensitivity.

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 eye strain, itching, pressure, redness, styes, swelling, twitching and sensitivity.

Dosage & Administration Section

Directions: Ages 12 and up, take 6 drops 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. Warning: Do not place in the eye.

Otc Active Ingredient Section

Equal parts of Echinacea 6x, Phytolacca 6x, Aconitum nap. 15x, Allium cepa 15x, Arsenicum alb. 15x, Bryonia 15x, Calendula 15x, Chelidonium maj. 15x, Cineraria 15x, Euphrasia 15x, Graphites 15x, Lycopodium 15x, Merc. corros. 15x, Nux vom. 15x, Phos. 15x, Phytolacca 15x, Picricum ac. 15x, Pulsatilla 15x, Rhus tox. 15x, Sulphur 15x.

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 worsen 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 eye strain, itching, pressure, redness, styes, swelling, twitching and sensitivity.

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 eye strain, itching, pressure, redness, styes, swelling, twitching and sensitivity.

Dosage & Administration Section (DOSAGE & ADMINISTRATION SECTION)

Directions: Ages 12 and up, take 6 drops 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. Warning: Do not place in the eye.

Otc Active Ingredient Section (OTC - ACTIVE INGREDIENT SECTION)

Equal parts of Echinacea 6x, Phytolacca 6x, Aconitum nap. 15x, Allium cepa 15x, Arsenicum alb. 15x, Bryonia 15x, Calendula 15x, Chelidonium maj. 15x, Cineraria 15x, Euphrasia 15x, Graphites 15x, Lycopodium 15x, Merc. corros. 15x, Nux vom. 15x, Phos. 15x, Phytolacca 15x, Picricum ac. 15x, Pulsatilla 15x, Rhus tox. 15x, Sulphur 15x.

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)