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 pellet
Newton Laboratories, Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Eye 2435P

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 pellets by mouth (ages 0 to 11, give 3 pellets) as needed or as directed by a health professional. Under age 2, crush or dissolve pellets in purified water. Sensitive persons begin with 1 pellet and gradually increase to full dose.

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 - PURPOSE SECTION

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Gluten-free, non-GMO, organic beet-derived sucrose (lactose-free) pellets.

QUESTIONS SECTION

newtonlabs.net – Questions? 800.448.7256

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

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.

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.

PACKAGE LABEL

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 pellet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55714-2435
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PICRIC ACID (UNII: A49OS0F91S) (PICRIC ACID - UNII:A49OS0F91S)	PICRIC ACID	15 [hp_X] in 1 g
ACONITUM NAPELLUS (UNII: U0NQ8555JD) (ACONITUM NAPELLUS - UNII:U0NQ8555JD)	ACONITUM NAPELLUS	15 [hp_X] in 1 g
ONION (UNII: 492225Q21H) (ONION - UNII:492225Q21H)	ONION	15 [hp_X] in 1 g
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV)	ARSENIC TRIOXIDE	15 [hp_X] in 1 g
BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B)	BRYONIA ALBA ROOT	15 [hp_X] in 1 g
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)	CALENDULA OFFICINALIS FLOWERING TOP	15 [hp_X] in 1 g
CHELIDONIUM MAJUS (UNII: 7E889U5RNN) (CHELIDONIUM MAJUS - UNII:7E889U5RNN)	CHELIDONIUM MAJUS	15 [hp_X] in 1 g
JACOBAEA MARITIMA (UNII: U4B223LS4X) (JACOBAEA MARITIMA - UNII:U4B223LS4X)	JACOBAEA MARITIMA	15 [hp_X] in 1 g
EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL)	EUPHRASIA STRICTA	15 [hp_X] in 1 g
GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O)	GRAPHITE	15 [hp_X] in 1 g
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	15 [hp_X] in 1 g
MERCURIC CHLORIDE (UNII: 53GH7MZT1R) (MERCURIC CATION - UNII:ED30FJ8Y42)	MERCURIC CHLORIDE	15 [hp_X] in 1 g
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919)	STRYCHNOS NUX-VOMICA SEED	15 [hp_X] in 1 g
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W)	PHOSPHORUS	15 [hp_X] in 1 g
PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG)	PHYTOLACCA AMERICANA ROOT	15 [hp_X] in 1 g
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	15 [hp_X] in 1 g
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	15 [hp_X] in 1 g
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	15 [hp_X] in 1 g
ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX)	ECHINACEA, UNSPECIFIED	6 [hp_X] in 1 g

Ingredient Name	Strength
Inactive Ingredients
SUCROSE (UNII: C151H8M554)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55714-2435-1	28 g in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	01/31/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		01/31/2019

Labeler - Newton Laboratories, Inc. (788793610)

Registrant - Newton Laboratories, Inc. (788793610)

Name	Address	ID/FEI	Business Operations
Establishment
Newton Laboratories, Inc.		788793610	manufacture(55714-2435)

Revised: 1/2019

Document Id: 924e5fae-dabd-2b32-e053-2a95a90a9f40

Set id: 924e562a-d9ae-5cae-e053-2995a90ace38

Version: 1

Effective Time: 20190131

Newton Laboratories, Inc.