FDA.reportPublic FDA data

Eye Floaters

Manufacturer
Newton Laboratories, Inc.
Effective date
2020-12-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:13:48

Label at a glance#

ProductEye Floaters
Active ingredientALOE, CAUSTICUM, CHELIDONIUM MAJUS, CHOLESTEROL, CINCHONA OFFICINALIS BARK, COLCHICUM AUTUMNALE BULB, CYCLAMEN PURPURASCENS TUBER, EUPHRASIA STRICTA, GELSEMIUM SEMPERVIRENS ROOT, POTASSIUM CARBONATE, MERCURY, PHOSPHORUS, PHYSOSTIGMA VENENOSUM SEED, PRUNUS SPINOSA FLOWER BUD, POLYGALA SENEGA ROOT, SEPIA OFFICINALIS JUICE, SULFUR, TOBACCO LEAF, ACTIVATED CHARCOAL
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Formulated for associated symptoms such as dark or grey specks and strings or cobwebs of material floating within the field of vision.

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 drops by mouth one to four times daily or as directed by a health professional. Warning: If an increase in floaters is accompanied by flashes of light or loss of peripheral vision, see and eye specialist immediately.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Aloe 15x, Carbo vegetabilis 15x, Causticum 15x, Chelidonium majus 15x, Cholesterinum 15x, Cinchona officinalis 15x, Colchicum autumnale 15x, Cyclamen europaeum 15x, Euphrasia, Gelsemium sempervirens 15x, Kali carbonicum 15x, Mercurius vivus 15x, Phosphorus 15x, Physostigma venenosum 15x, Prunus spinosa 15x, Senega officinalis 15x, Sepia 15x, Sulphur 15x, Tabacum 15x.

OTC - PURPOSE SECTION

Formulated for associated symptoms such as dark or grey specks and strings or cobwebs of material floating within the field of vision.

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-4774-1Eye Floaters30 mL in 1 BOTTLE, GLASSLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4774EYE FLOATERS (ALOE, CARBO VEGETABILIS, CAUSTICUM, CHELIDONIUM MAJUS, CHOLESTERINUM, CINCHONA OFFICINALIS, COLCHICUM AUTUMNALE, CYCLAMEN EUROPAEUM, GELSEMIUM SEMPERVIRENS, KALI CARBONICUM, MERCURIUS VIVUS, PHOSPHORUS, PHYSOSTIGMA VENENOSUM, PRUNUS SPINOSA, SENEGA OFFICINALIS, SEPIA, SULPHUR, TABACUM.) LIQUID [NEWTON LABORATORIES, INC.]2Current NDC, Legacy NDC, 1 package rows20201204_9a00f7a3-aa76-78ac-e053-2995a90a8c66.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-477455714-4774-1

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
ALOEV5VD430YW9ACTIB
CAUSTICUMDD5FO1WKFUACTIB
CHELIDONIUM MAJUS7E889U5RNNACTIB
CHOLESTEROL97C5T2UQ7JACTIB
CINCHONA OFFICINALIS BARKS003A158SBACTIB
COLCHICUM AUTUMNALE BULB993QHL78E6ACTIB
CYCLAMEN PURPURASCENS TUBERG728143D8QACTIB
EUPHRASIA STRICTAC9642I91WLACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
POTASSIUM CARBONATEBQN1B9B9HAACTIB
MERCURYFXS1BY2PGLACTIB
PHOSPHORUS27YLU75U4WACTIB
PHYSOSTIGMA VENENOSUM SEEDCJV9E9IIOAACTIB
PRUNUS SPINOSA FLOWER BUD53Y84VPS2WACTIB
POLYGALA SENEGA ROOTM7T6H7D4IFACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
SULFUR70FD1KFU70ACTIB
TOBACCO LEAF6YR2608RSUACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
ACTIVATED CHARCOAL2P3VWU3H10ACTIB

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 FloatersALOE, CARBO VEGETABILIS, CAUSTICUM, CHELIDONIUM MAJUS, CHOLESTERINUM, CINCHONA OFFICINALIS, COLCHICUM AUTUMNALE, CYCLAMEN EUROPAEUM, GELSEMIUM SEMPERVIRENS, KALI CARBONICUM, MERCURIUS VIVUS, PHOSPHORUS, PHYSOSTIGMA VENENOSUM, PRUNUS SPINOSA, SENEGA OFFICINALIS, SEPIA, SULPHUR, TABACUM.Newton Laboratories, Inc.9a00f7a3-aa76-78ac-e053-2995a90a8c662020-12-03WarningsExact identifier
ndc (package): 55714-4774-1
ndc (product): 55714-4774
ndc11 (package): 55714477401
spl id: b5928f0a-8a3c-6765-e053-2995a90a9011
spl set id: 9a00f7a3-aa76-78ac-e053-2995a90a8c66

Reported adverse events (FAERS/openFDA)#

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