FDA.reportPublic FDA data

Cataracts-Adjunctive Complex

Manufacturer
Newton Laboratories, Inc.
Effective date
2019-11-21
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:58:00

Label at a glance#

ProductCataracts-Adjunctive Complex
Active ingredientARSENIC TRIOXIDE, BRYONIA ALBA ROOT, CALCIUM FLUORIDE, CALENDULA OFFICINALIS FLOWERING TOP, CAUSTICUM, CONIUM MACULATUM FLOWERING TOP, EUPHRASIA STRICTA, HYDROFLUORIC ACID, IODINE, LEDUM PALUSTRE TWIG, NAPHTHALENE, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUS, ANEMONE PULSATILLA, SEPIA OFFICINALIS JUICE, SILICON DIOXIDE, TELLURIUM, ALLYLTHIOUREA, ZINC
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Formulated for associated symptoms such as blurred vision, photophobia, diplopia and opacities.

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 drops by mputh one to four times daily or as directed by a health professional.

ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Arsenicum alb. 15x, Bryonia 15x, Calc. fluor. 15x, Calendula 15x, Causticum 15x, Conium 15x, Euphrasia 15x, Hydrofluoricum acidum 15x, Iodium 15x, Ledum 15x, Naphthalinum 15x, Nat. mur. 15x, Nux vom. 15x, Phosphorus 15x, Pulsatilla 15x, Sepia 15x, Silicea 15x, Tellurium metallicum 15x, Thiosinaminum 15x, Zinc. met. 15x.

PURPOSE SECTION

INDICATIONS & USAGE SECTION

Formulated for associated symptoms such as blurred vision, photophobia, diplopia and opacities.

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.

PREGNANCY OR BREAST FEEDING SECTION

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a doctor before use.

KEEP OUT OF REACH OF CHILDREN SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package labelpackage label

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-465255714-4652-1, 55714-4652-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
ARSENIC TRIOXIDES7V92P67HOACTIB
BRYONIA ALBA ROOTT7J046YI2BACTIB
CALCIUM FLUORIDEO3B55K4YKIACTIB
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB
CAUSTICUMDD5FO1WKFUACTIB
CONIUM MACULATUM FLOWERING TOPQ28R5GF371ACTIB
EUPHRASIA STRICTAC9642I91WLACTIB
HYDROFLUORIC ACIDRGL5YE86CZACTIM
IODINE9679TC07X4ACTIB
LEDUM PALUSTRE TWIG877L01IZ0PACTIB
NAPHTHALENE2166IN72UNACTIB
SODIUM CHLORIDE451W47IQ8XACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
PHOSPHORUS27YLU75U4WACTIB
ANEMONE PULSATILLAI76KB35JEVACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
SILICON DIOXIDEETJ7Z6XBU4ACTIB
TELLURIUMNQA0O090ZJACTIB
ALLYLTHIOUREA706IDJ14B7ACTIB
ZINCJ41CSQ7QDSACTIB

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
b67443a3-8f9e-67a8-e053-2995a90abc9b97deaa52-5afb-0186-e053-2995a90ab1792020-12-14WarningsExact identifier
spl set id: 97deaa52-5afb-0186-e053-2995a90ab179

Reported adverse events (FAERS/openFDA)#

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