FDA.reportPublic FDA data

Cataracts

Manufacturer
Newton Laboratories, Inc.
Effective date
2011-06-01
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:03:50

Label at a glance#

ProductCataracts
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, Pulsatilla Vulgaris, Sepia Officinalis Juice, Silicon Dioxide, Tellurium, Allylthiourea, Zinc
Label structure10 sections

Label contents#

Full prescribing information#

PRODUCT NAME & INDICATIONS SECTION

INDICATIONS & USAGE SECTION

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

DIRECTION SECTION

DOSAGE & ADMINISTRATION SECTION

Directions: ORAL USE ONLY - SHAKE WELL. Ages 12 and up, take 6 drops orally one to four times daily or as directed by a healthcare professional.      

ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

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, Euphrasia 3x.       

PURPOSE SECTION

ABUSE SECTION

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

INACTIVE INGREDIENT SECTION

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

QUESTIONS? SECTION

OTC - 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 or 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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package Label
Package Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55714-4588-12020-01-31C16284748780-19d75b9d1-07e6-f424-e053-dadaa90a57ceCataracts
55714-4588-22020-01-31C16284748780-19d75b9d1-07e6-f424-e053-dadaa90a57ceCataracts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-4588-1Cataracts29.57 mL in 1 BOTTLE, GLASSLIQUID29.571
55714-4588-2Cataracts59.14 mL in 1 BOTTLE, GLASSLIQUID59.141

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4588CATARACTS (ARSENICUM ALB., BRYONIA, CALC. FLUOR., CALENDULA, CAUSTICUM, CONIUM , EUPHRASIA, HYDROFLUORICUM ACIDUM , IODIUM, LEDUM, NAPHTHALINUM, NAT. MUR., NUX VOM., PHOSPHORUS, PULSATILLA, SEPIA, SILICEA, TELLURIUM METALLICUM, THIOSINAMINUM, ZINC. MET., EUPHRASIA) LIQUID [NEWTON LABORATORIES, INC.]1Legacy NDC, 2 package rows20120621_9f70e311-9d2c-1748-c8ce-b42174b6716d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AllylthioureaACTIVE INGREDIENT706IDJ14B71
Arsenic TrioxideACTIVE INGREDIENTS7V92P67HO1
Bryonia Alba RootACTIVE INGREDIENTT7J046YI2B1
Calcium FluorideACTIVE INGREDIENTO3B55K4YKI1
Calendula Officinalis Flowering TopACTIVE INGREDIENT18E7415PXQ1
CausticumACTIVE INGREDIENTDD5FO1WKFU1
Conium Maculatum Flowering TopACTIVE INGREDIENTQ28R5GF3711
Euphrasia StrictaACTIVE INGREDIENTC9642I91WL1
Hydrofluoric AcidACTIVE INGREDIENTRGL5YE86CZ1
IodineACTIVE INGREDIENT9679TC07X41
Ledum Palustre TwigACTIVE INGREDIENT877L01IZ0P1
NaphthaleneACTIVE INGREDIENT2166IN72UN1
PhosphorusACTIVE INGREDIENT27YLU75U4W1
Pulsatilla VulgarisACTIVE INGREDIENTI76KB35JEV1
Sepia Officinalis JuiceACTIVE INGREDIENTQDL83WN8C21
Silicon DioxideACTIVE INGREDIENTETJ7Z6XBU41
Sodium ChlorideACTIVE INGREDIENT451W47IQ8X1
Strychnos Nux-vomica SeedACTIVE INGREDIENT269XH139191
TelluriumACTIVE INGREDIENTNQA0O090ZJ1
ZincACTIVE INGREDIENTJ41CSQ7QDS1
AllylthioureaACTIVE MOIETY706IDJ14B71
Arsenic TrioxideACTIVE MOIETYS7V92P67HO1
Bryonia Alba RootACTIVE MOIETYT7J046YI2B1
Calcium FluorideACTIVE MOIETYO3B55K4YKI1
Calendula Officinalis Flowering TopACTIVE MOIETY18E7415PXQ1
CausticumACTIVE MOIETYDD5FO1WKFU1
Conium Maculatum Flowering TopACTIVE MOIETYQ28R5GF3711
Euphrasia StrictaACTIVE MOIETYC9642I91WL1
Hydrofluoric AcidACTIVE MOIETYRGL5YE86CZ1
IodineACTIVE MOIETY9679TC07X41
Ledum Palustre TwigACTIVE MOIETY877L01IZ0P1
NaphthaleneACTIVE MOIETY2166IN72UN1
PhosphorusACTIVE MOIETY27YLU75U4W1
Pulsatilla VulgarisACTIVE MOIETYI76KB35JEV1
Sepia Officinalis JuiceACTIVE MOIETYQDL83WN8C21
Silicon DioxideACTIVE MOIETYETJ7Z6XBU41
Sodium CationACTIVE MOIETYLYR4M0NH371
Strychnos Nux-vomica SeedACTIVE MOIETY269XH139191
TelluriumACTIVE MOIETYNQA0O090ZJ1
ZincACTIVE MOIETYJ41CSQ7QDS1
AlcoholINACTIVE INGREDIENT3K9958V90M1

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
55714-458855714-4588-1, 55714-4588-2

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
Arsenic TrioxideS7V92P67HOACTIB
Bryonia Alba RootT7J046YI2BACTIB
Calcium FluorideO3B55K4YKIACTIB
Calendula Officinalis Flowering Top18E7415PXQACTIB
CausticumDD5FO1WKFUACTIB
Conium Maculatum Flowering TopQ28R5GF371ACTIB
Euphrasia StrictaC9642I91WLACTIB
Hydrofluoric AcidRGL5YE86CZACTIB
Iodine9679TC07X4ACTIB
Ledum Palustre Twig877L01IZ0PACTIB
Naphthalene2166IN72UNACTIB
Sodium Chloride451W47IQ8XACTIB
Strychnos Nux-vomica Seed269XH13919ACTIB
Phosphorus27YLU75U4WACTIB
Pulsatilla VulgarisI76KB35JEVACTIB
Sepia Officinalis JuiceQDL83WN8C2ACTIB
Silicon DioxideETJ7Z6XBU4ACTIB
TelluriumNQA0O090ZJACTIB
Allylthiourea706IDJ14B7ACTIB
ZincJ41CSQ7QDSACTIB
Euphrasia StrictaC9642I91WLACTIB
Alcohol3K9958V90MIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 59 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
AlcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates

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
000950e6-1774-b77d-e8c2-bd12a396e5449f70e311-9d2c-1748-c8ce-b42174b6716d2011-06-01WarningsExact identifier
spl id: 000950e6-1774-b77d-e8c2-bd12a396e544
spl set id: 9f70e311-9d2c-1748-c8ce-b42174b6716d

Reported adverse events (FAERS/openFDA)#

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