FDA.reportPublic FDA data

Eye Care

Manufacturer
Newton Laboratories, Inc.
Effective date
2020-11-25
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:13:37

Label at a glance#

ProductEye Care
Active ingredientACONITUM NAPELLUS, ONION, ARSENIC TRIOXIDE, BRYONIA ALBA ROOT, CALENDULA OFFICINALIS FLOWERING TOP, CHELIDONIUM MAJUS, JACOBAEA MARITIMA, EUPHRASIA STRICTA, GRAPHITE, LYCOPODIUM CLAVATUM SPORE, MERCURIC CHLORIDE, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUS, PHYTOLACCA AMERICANA ROOT, PULSATILLA VULGARIS, TOXICODENDRON PUBESCENS LEAF, SULFUR, ECHINACEA, UNSPECIFIED, PICRIC ACID
Label structure10 sections

Label contents#

Full prescribing information#

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 - 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%.

QUESTIONS SECTION

OTC - 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.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-2434-0Eye Care15 mL in 1 BOTTLE, GLASSLIQUID153
55714-2434-1Eye Care30 mL in 1 BOTTLE, GLASSLIQUID303
55714-2434-2Eye Care50 mL in 1 BOTTLE, GLASSLIQUID503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2434EYE 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.]3Current NDC, Legacy NDC, 3 package rows20201126_924e15f1-92af-7fc9-e053-2995a90a1fcc.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-243455714-2434-1, 55714-2434-2, 55714-2434-0

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
ACONITUM NAPELLUSU0NQ8555JDACTIB
ONION492225Q21HACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB
CHELIDONIUM MAJUS7E889U5RNNACTIB
JACOBAEA MARITIMAU4B223LS4XACTIB
EUPHRASIA STRICTAC9642I91WLACTIB
GRAPHITE4QQN74LH4OACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
MERCURIC CHLORIDE53GH7MZT1RACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
PHOSPHORUS27YLU75U4WACTIB
PHYTOLACCA AMERICANA ROOT11E6VI8VEGACTIB
PULSATILLA VULGARISI76KB35JEVACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
SULFUR70FD1KFU70ACTIB
ECHINACEA, UNSPECIFIED4N9P6CC1DXACTIB
PICRIC ACIDA49OS0F91SACTIB
WATER059QF0KO0RIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eye CareACONITUM 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, ECHINACEANewton Laboratories, Inc.924e15f1-92af-7fc9-e053-2995a90a1fcc2020-11-25WarningsExact identifier
ndc (package): 55714-2434-0
ndc (package): 55714-2434-1
ndc (package): 55714-2434-2
ndc (product): 55714-2434
ndc11 (package): 55714243401
ndc11 (package): 55714243400
ndc11 (package): 55714243402
spl id: b4f4bf9f-d252-a951-e053-2a95a90ad028
spl set id: 924e15f1-92af-7fc9-e053-2995a90a1fcc

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.