EYE CARE- aconitum nap. , allium cepa, arsenicum alb., bryonia, calendula, chelidonium majus, cineraria, euphrasia, graphites, lycopodium, merc. corros., nux vom., phosphorus, phytolacca, picricum ac., pulsatilla, rhus toxicodendron, sulphur, echinacea liquid
Newton Laboratories, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Eye Care

INDICATIONS & USAGE SECTION

Eye Care Formulated for symptoms associated with eye conditions such as itching, swelling, redness, discharge and excessive tears.

DOSAGE & ADMINISTRATION SECTION

Directions: ORAL USE ONLY - SHAKE WELL. Pets, under 50 lbs., give 3 drops orally (50 to 500 lbs. - 6 drops, over 500 lbs. - 1/2 teaspoon) as needed or as directed by a healthcare professional. Place in mouth or purified water. Warning: Do not place in the eye.

OTC - ACTIVE INGREDIENT SECTION

Aconitum nap. 15x, Allium cepa 15x, Arsenicum alb. 15x, Bryonia 15x, Calendula 15x, Chelidonium majus 15x, Cineraria 15x, Euphrasia 15x, Graphites 15x, Lycopodium 15x, Merc. corros. 15x, Nux vom. 15x, Phosphorus 15x, Phytolacca 15x, Picricum ac. 15x, Pulsatilla 15x, Rhus toxicodendron 15x, Sulphur 15x, Echinacea 3x, Phytolacca 3x.

OTC - PURPOSE SECTION

Formulated for symptoms associated with eye conditions such as itching, swelling, redness, discharge and excessive tears.

INACTIVE INGREDIENT SECTION

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

QUESTIONS SECTION

www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions? 1.800.448.7256

WARNINGS SECTION

Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.

OTC - PREGNANCY OR BREAST FEEDING SECTION

Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

EYE CARE
aconitum nap. , allium cepa, arsenicum alb., bryonia, calendula, chelidonium majus, cineraria, euphrasia, graphites, lycopodium, merc. corros., nux vom., phosphorus, phytolacca, picricum ac., pulsatilla, rhus toxicodendron, sulphur, echinacea liquid

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC:55714-4269
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Aconitum Napellus (UNII: U0NQ8555JD) (Aconitum Napellus - UNII:U0NQ8555JD)	Aconitum Napellus	15 [hp_X] in 1 mL
Onion (UNII: 492225Q21H) (Onion - UNII:492225Q21H)	Onion	15 [hp_X] in 1 mL
Arsenic Trioxide (UNII: S7V92P67HO) (Arsenic Cation (3+) - UNII:C96613F5AV)	Arsenic Trioxide	15 [hp_X] in 1 mL
Bryonia Alba Root (UNII: T7J046YI2B) (Bryonia Alba Root - UNII:T7J046YI2B)	Bryonia Alba Root	15 [hp_X] in 1 mL
Calendula Officinalis Flowering Top (UNII: 18E7415PXQ) (Calendula Officinalis Flowering Top - UNII:18E7415PXQ)	Calendula Officinalis Flowering Top	15 [hp_X] in 1 mL
Chelidonium Majus (UNII: 7E889U5RNN) (Chelidonium Majus - UNII:7E889U5RNN)	Chelidonium Majus	15 [hp_X] in 1 mL
Jacobaea Maritima (UNII: U4B223LS4X) (Jacobaea Maritima - UNII:U4B223LS4X)	Jacobaea Maritima	15 [hp_X] in 1 mL
Euphrasia Stricta (UNII: C9642I91WL) (Euphrasia Stricta - UNII:C9642I91WL)	Euphrasia Stricta	15 [hp_X] in 1 mL
Graphite (UNII: 4QQN74LH4O) (Graphite - UNII:4QQN74LH4O)	Graphite	15 [hp_X] in 1 mL
Lycopodium Clavatum Spore (UNII: C88X29Y479) (Lycopodium Clavatum Spore - UNII:C88X29Y479)	Lycopodium Clavatum Spore	15 [hp_X] in 1 mL
Mercuric Chloride (UNII: 53GH7MZT1R) (Mercuric Cation - UNII:ED30FJ8Y42)	Mercuric Chloride	15 [hp_X] in 1 mL
Strychnos Nux-vomica Seed (UNII: 269XH13919) (Strychnos Nux-vomica Seed - UNII:269XH13919)	Strychnos Nux-vomica Seed	15 [hp_X] in 1 mL
Phosphorus (UNII: 27YLU75U4W) (Phosphorus - UNII:27YLU75U4W)	Phosphorus	15 [hp_X] in 1 mL
Phytolacca Americana Root (UNII: 11E6VI8VEG) (Phytolacca Americana Root - UNII:11E6VI8VEG)	Phytolacca Americana Root	15 [hp_X] in 1 mL
Picric Acid (UNII: A49OS0F91S) (Picric Acid - UNII:A49OS0F91S)	Picric Acid	15 [hp_X] in 1 mL
Pulsatilla Vulgaris (UNII: I76KB35JEV) (Pulsatilla Vulgaris - UNII:I76KB35JEV)	Pulsatilla Vulgaris	15 [hp_X] in 1 mL
Toxicodendron Pubescens Leaf (UNII: 6IO182RP7A) (Toxicodendron Pubescens Leaf - UNII:6IO182RP7A)	Toxicodendron Pubescens Leaf	15 [hp_X] in 1 mL
Sulfur (UNII: 70FD1KFU70) (Sulfur - UNII:70FD1KFU70)	Sulfur	15 [hp_X] in 1 mL
Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX)	Echinacea, Unspecified	3 [hp_X] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Alcohol (UNII: 3K9958V90M)

#	Item Code	Package Description
Packaging
1	NDC:55714-4269-1	29.57 mL in 1 BOTTLE, GLASS
2	NDC:55714-4269-2	59.14 mL in 1 BOTTLE, GLASS
3	NDC:55714-4269-0	.5 mL in 1 BOTTLE, GLASS

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		03/01/2011	12/31/2018

Labeler - Newton Laboratories, Inc. (788793610)

Registrant - Newton Laboratories, Inc. (788793610)

Name	Address	ID/FEI	Business Operations
Establishment
Newton Laboratories, Inc.		788793610	MANUFACTURE, API MANUFACTURE

Revised: 3/2011

Document Id: 592ddddc-7c70-4bdc-8c2a-76849e5b7653

Set id: 659272a9-d56a-0cf9-0855-8b04d69dbb02

Version: 4

Effective Time: 20110301

Newton Laboratories, Inc.