FDA.reportPublic FDA data

Macular Degeneration

Manufacturer
Newton Laboratories, Inc.
Effective date
2011-06-01
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:05:27

Label at a glance#

ProductMacular Degeneration
Active ingredientMicrurus Corallinus Venom, Aconitum Napellus, Gold, Barium Carbonate, Atropa Belladonna, Crotalus Horridus Horridus Venom, Gelsemium Sempervirens Root, Hamamelis Virginiana Root Bark/stem Bark, Lachesis Muta Venom, Mercury, Phosphorus, Picric Acid, Lead, Pulsatilla Vulgaris, Toxicodendron Pubescens Leaf, Datura Stramonium, Theridion Curassavicum, Euphrasia Stricta
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

INDICATIONS & USAGE SECTION

Macular Degeneration  Formulated for symptoms of atrophic and neovascular forms of macular degeneration as well as symptoms associated with the macula and retina.

DOSAGE & ADMINISTRATION 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

Elaps corallinus 30x, Aconitum nap. 15x, Aur. met. 15x, Baryta carb. 15x, Belladonna 15x, Crotalus horridus 15x, Gelsemium 15x, Hamamelis 15x, Lachesis 15x, Merc. viv. 15x, Phosphorus 15x, Picricum ac. 15x, Plumbum met. 15x, Pulsatilla 15x, Rhus toxicodendron 15x, Stramonium 15x, Theridion 15x, Euphrasia 3x.

PURPOSE SECTION

ABUSE SECTION

Formulated for symptoms of atrophic and neovascular forms of macular degeneration as well as symptoms associated with the macula and retina.

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.

PREGNANCY OR BREAST FEEDING SECTION

OTC - PREGNANCY OR BREAST FEEDING SECTION

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 SECTION

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55714-4598-12020-01-31C16284748780-19d75b9d0-769c-f424-e053-dadaa90a57ceMacular Degeneration
55714-4598-22020-01-31C16284748780-19d75b9d0-769c-f424-e053-dadaa90a57ceMacular Degeneration

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-4598-1Macular Degeneration29.57 mL in 1 BOTTLE, GLASSLIQUID29.573
55714-4598-2Macular Degeneration59.14 mL in 1 BOTTLE, GLASSLIQUID59.143

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4598MACULAR DEGENERATION (ELAPS CORALLINUS, ACONITUM NAP.,AUR. MET., BARYTA CARB., BELLADONNA, CROTALUS HORRIDUS, GELSEMIUM, HAMAMELIS, LACHESIS, MERC. VIV.,PHOSPHORUS, PICRICUM AC., PLUMBUM MET., PULSATILLA,RHUS TOXICODENDRON, STRAMONIUM, THERIDION, EUPHRASIA) LIQUID [NEWTON LABORATORIES, INC.]3Legacy NDC, 2 package rows20140211_5b025376-4ecd-8422-6a4e-2f759bd06240.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Aconitum NapellusACTIVE INGREDIENTU0NQ8555JD3
Atropa BelladonnaACTIVE INGREDIENTWQZ3G9PF0H3
Barium CarbonateACTIVE INGREDIENT6P669D8HQ83
Crotalus Horridus Horridus VenomACTIVE INGREDIENTYHA2XLJ9563
Datura StramoniumACTIVE INGREDIENTG6W4F0V8Z33
Euphrasia StrictaACTIVE INGREDIENTC9642I91WL3
Gelsemium Sempervirens RootACTIVE INGREDIENT639KR60Q1Q3
GoldACTIVE INGREDIENT79Y1949PYO3
Hamamelis Virginiana Root Bark/stem BarkACTIVE INGREDIENTT7S323PKJS3
Lachesis Muta VenomACTIVE INGREDIENTVSW71SS07I3
LeadACTIVE INGREDIENT2P299V784P3
MercuryACTIVE INGREDIENTFXS1BY2PGL3
Micrurus Corallinus VenomACTIVE INGREDIENTV0S6H369803
PhosphorusACTIVE INGREDIENT27YLU75U4W3
Picric AcidACTIVE INGREDIENTA49OS0F91S3
Pulsatilla VulgarisACTIVE INGREDIENTI76KB35JEV3
Theridion CurassavicumACTIVE INGREDIENT9Z8D3HEM8L3
Toxicodendron Pubescens LeafACTIVE INGREDIENT6IO182RP7A3
Aconitum NapellusACTIVE MOIETYU0NQ8555JD3
Atropa BelladonnaACTIVE MOIETYWQZ3G9PF0H3
Barium CationACTIVE MOIETYV645272HLN3
Crotalus Horridus Horridus VenomACTIVE MOIETYYHA2XLJ9563
Datura StramoniumACTIVE MOIETYG6W4F0V8Z33
Euphrasia StrictaACTIVE MOIETYC9642I91WL3
Gelsemium Sempervirens RootACTIVE MOIETY639KR60Q1Q3
GoldACTIVE MOIETY79Y1949PYO3
Hamamelis Virginiana Root Bark/stem BarkACTIVE MOIETYT7S323PKJS3
Lachesis Muta VenomACTIVE MOIETYVSW71SS07I3
LeadACTIVE MOIETY2P299V784P3
MercuryACTIVE MOIETYFXS1BY2PGL3
Micrurus Corallinus VenomACTIVE MOIETYV0S6H369803
PhosphorusACTIVE MOIETY27YLU75U4W3
Picric AcidACTIVE MOIETYA49OS0F91S3
Pulsatilla VulgarisACTIVE MOIETYI76KB35JEV3
Theridion CurassavicumACTIVE MOIETY9Z8D3HEM8L3
Toxicodendron Pubescens LeafACTIVE MOIETY6IO182RP7A3
AlcoholINACTIVE INGREDIENT3K9958V90M3

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-459855714-4598-1, 55714-4598-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
Micrurus Corallinus VenomV0S6H36980ACTIB
Aconitum NapellusU0NQ8555JDACTIB
Gold79Y1949PYOACTIB
Barium Carbonate6P669D8HQ8ACTIB
Atropa BelladonnaWQZ3G9PF0HACTIB
Crotalus Horridus Horridus VenomYHA2XLJ956ACTIB
Gelsemium Sempervirens Root639KR60Q1QACTIB
Hamamelis Virginiana Root Bark/stem BarkT7S323PKJSACTIB
Lachesis Muta VenomVSW71SS07IACTIB
MercuryFXS1BY2PGLACTIB
Phosphorus27YLU75U4WACTIB
Picric AcidA49OS0F91SACTIB
Lead2P299V784PACTIB
Pulsatilla VulgarisI76KB35JEVACTIB
Toxicodendron Pubescens Leaf6IO182RP7AACTIB
Datura StramoniumG6W4F0V8Z3ACTIB
Theridion Curassavicum9Z8D3HEM8LACTIB
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
AlcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact 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
c98ecee8-3d53-392a-8a79-459cebd19d1e5b025376-4ecd-8422-6a4e-2f759bd062402011-06-01WarningsExact identifier
spl id: c98ecee8-3d53-392a-8a79-459cebd19d1e
spl set id: 5b025376-4ecd-8422-6a4e-2f759bd06240

Reported adverse events (FAERS/openFDA)#

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