FDA.reportPublic FDA data

Fungal Infection

Manufacturer
Newton Laboratories, Inc.
Effective date
2011-06-01
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:04:58

Label at a glance#

ProductFungal Infection
Active ingredientCandida Albicans, Sanicula Europaea Leaf, Tellurium, Saccharomyces Cerevisiae, Antimony Trisulfide, Arsenic Trioxide, Barium Carbonate, Bryonia Alba Root, Oyster Shell Calcium Carbonate, Crude, Activated Charcoal, Copper, Solanum Dulcamara Top, Graphite, Potassium Carbonate, Lachesis Muta Venom, Lycopodium Clavatum Spore, Daphne Mezereum Bark, Nitric Acid, Phosphorus, Phytolacca Americana Root, Sepia Officinalis Juice, Silicon Dioxide, Sulfur, Sulfuric Acid, Zinc, Apis Mellifera, Thuja Occidentalis Leafy Twig
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

INDICATIONS & USAGE SECTION

FUNGAL INFECTION  Formulated for symptoms associated with tinea versicolor, tinea corporis, tinea cruris, tinea pedis, onychomycosis and other fungal infections.        

DOSAGE & ADMINISTRATION SECTION

DOSAGE & ADMINISTRATION SECTION

Directions: ORAL USE ONLY - SHAKE WELL. Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) as needed or as directed by a healthcare professional.           

ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

Candida albicans 20x, Sanicula 20x, Tellurium metallicum 20x, Torula cerevisiae 20x, Antimon. crud. 15x, Arsenicum alb. 15x, Baryta carb. 15x, Bryonia 15x, Calc. carb. 15x, Carbo veg. 15x, Cuprum met. 15x, Dulcamara 15x, Graphites 15x, Kali carb. 15x, Lachesis 15x,  Lycopodium 15x, Mezereum 15x, Nitricum ac. 15x, Phosphorus 15x, Phytolacca 15x, Sepia 15x, Silicea 15x, Sulphur 15x, Sulphuricum ac. 15x, Zinc. met. 15x, Apis mel. 8x, Phytolacca 8x, Thuja 8x, Apis mel. 3x, Phytolacca 3x, Thuja 3x.            

PURPOSE SECTION

ABUSE SECTION

Formulated for symptoms associated with tinea versicolor, tinea corporis, tinea cruris, tinea pedis, onychomycosis and other fungal infections.

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 or 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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c599c4a0-705d-4ebb-ab1f-977af038f96aProduct name120251124
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55714-4618-12020-01-31C16284748780-19d75b9cf-d469-f424-e053-dadaa90a57ceFungal Infection
55714-4618-22020-01-31C16284748780-19d75b9cf-d469-f424-e053-dadaa90a57ceFungal Infection

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-4618-1Fungal Infection29.57 mL in 1 BOTTLE, GLASSLIQUID29.572
55714-4618-2Fungal Infection59.14 mL in 1 BOTTLE, GLASSLIQUID59.142

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4618FUNGAL INFECTION (CANDIDA ALBICANS, SANICULA, TELLURIUM METALLICUM, TORULA CEREVISIAE, ANTIMON. CRUD., ARSENICUM ALB., BARYTA CARB., BRYONIA, CALC. CARB., CARBO VEG., CUPRUM MET., DULCAMARA, GRAPHITES, KALI CARB., LACHESIS, LYCOPODIUM, MEZEREUM, NITRICUM AC., PHOSPHORUS, PHYTOLACCA, SEPIA, SILICEA, SULPHUR, SULPHURICUM AC., ZINC. MET., APIS MEL., THUJA.) LIQUID [NEWTON LABORATORIES, INC.]2Legacy NDC, 2 package rows20130912_931030b4-47e0-db78-37d5-445d88613ca1.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Activated CharcoalACTIVE INGREDIENT2P3VWU3H102
Antimony TrisulfideACTIVE INGREDIENTF79059A38U2
Apis MelliferaACTIVE INGREDIENT7S82P3R43Z2
Arsenic TrioxideACTIVE INGREDIENTS7V92P67HO2
Barium CarbonateACTIVE INGREDIENT6P669D8HQ82
Bryonia Alba RootACTIVE INGREDIENTT7J046YI2B2
Candida AlbicansACTIVE INGREDIENT4D7G21HDBC2
CopperACTIVE INGREDIENT789U1901C52
Daphne Mezereum BarkACTIVE INGREDIENTX2N6E405GV2
GraphiteACTIVE INGREDIENT4QQN74LH4O2
Lachesis Muta VenomACTIVE INGREDIENTVSW71SS07I2
Lycopodium Clavatum SporeACTIVE INGREDIENTC88X29Y4792
Nitric AcidACTIVE INGREDIENT411VRN1TV42
Oyster Shell Calcium Carbonate, CrudeACTIVE INGREDIENT2E32821G6I2
PhosphorusACTIVE INGREDIENT27YLU75U4W2
Phytolacca Americana RootACTIVE INGREDIENT11E6VI8VEG2
Potassium CarbonateACTIVE INGREDIENTBQN1B9B9HA2
Saccharomyces CerevisiaeACTIVE INGREDIENT978D8U419H2
Sanicula Europaea LeafACTIVE INGREDIENTJYZ6110L9I2
Sepia Officinalis JuiceACTIVE INGREDIENTQDL83WN8C22
Silicon DioxideACTIVE INGREDIENTETJ7Z6XBU42
Solanum Dulcamara TopACTIVE INGREDIENTKPS1B1162N2
SulfurACTIVE INGREDIENT70FD1KFU702
Sulfuric AcidACTIVE INGREDIENTO40UQP6WCF2
TelluriumACTIVE INGREDIENTNQA0O090ZJ2
Thuja Occidentalis Leafy TwigACTIVE INGREDIENT1NT28V93972
ZincACTIVE INGREDIENTJ41CSQ7QDS2
Activated CharcoalACTIVE MOIETY2P3VWU3H102
Antimony TrisulfideACTIVE MOIETYF79059A38U2
Apis MelliferaACTIVE MOIETY7S82P3R43Z2
Arsenic Cation (3+)ACTIVE MOIETYC96613F5AV2
Barium CationACTIVE MOIETYV645272HLN2
Bryonia Alba RootACTIVE MOIETYT7J046YI2B2
Candida AlbicansACTIVE MOIETY4D7G21HDBC2
Carbonate IonACTIVE MOIETY7UJQ5OPE7D2
CopperACTIVE MOIETY789U1901C52
Daphne Mezereum BarkACTIVE MOIETYX2N6E405GV2
GraphiteACTIVE MOIETY4QQN74LH4O2
Lachesis Muta VenomACTIVE MOIETYVSW71SS07I2
Lycopodium Clavatum SporeACTIVE MOIETYC88X29Y4792
Nitric AcidACTIVE MOIETY411VRN1TV42
Oyster Shell Calcium Carbonate, CrudeACTIVE MOIETY2E32821G6I2
PhosphorusACTIVE MOIETY27YLU75U4W2
Phytolacca Americana RootACTIVE MOIETY11E6VI8VEG2
Saccharomyces CerevisiaeACTIVE MOIETY978D8U419H2
Sanicula Europaea LeafACTIVE MOIETYJYZ6110L9I2
Sepia Officinalis JuiceACTIVE MOIETYQDL83WN8C22
Silicon DioxideACTIVE MOIETYETJ7Z6XBU42
Solanum Dulcamara TopACTIVE MOIETYKPS1B1162N2
SulfurACTIVE MOIETY70FD1KFU702
Sulfuric AcidACTIVE MOIETYO40UQP6WCF2
TelluriumACTIVE MOIETYNQA0O090ZJ2
Thuja Occidentalis Leafy TwigACTIVE MOIETY1NT28V93972
ZincACTIVE MOIETYJ41CSQ7QDS2
AlcoholINACTIVE INGREDIENT3K9958V90M2

Products#

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

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-461855714-4618-1, 55714-4618-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
Candida Albicans4D7G21HDBCACTIB
Sanicula Europaea LeafJYZ6110L9IACTIB
TelluriumNQA0O090ZJACTIB
Saccharomyces Cerevisiae978D8U419HACTIB
Antimony TrisulfideF79059A38UACTIB
Arsenic TrioxideS7V92P67HOACTIB
Barium Carbonate6P669D8HQ8ACTIB
Bryonia Alba RootT7J046YI2BACTIB
Oyster Shell Calcium Carbonate, Crude2E32821G6IACTIB
Activated Charcoal2P3VWU3H10ACTIB
Copper789U1901C5ACTIB
Solanum Dulcamara TopKPS1B1162NACTIB
Graphite4QQN74LH4OACTIB
Potassium CarbonateBQN1B9B9HAACTIB
Lachesis Muta VenomVSW71SS07IACTIB
Lycopodium Clavatum SporeC88X29Y479ACTIB
Daphne Mezereum BarkX2N6E405GVACTIB
Nitric Acid411VRN1TV4ACTIB
Phosphorus27YLU75U4WACTIB
Phytolacca Americana Root11E6VI8VEGACTIB
Sepia Officinalis JuiceQDL83WN8C2ACTIB
Silicon DioxideETJ7Z6XBU4ACTIB
Sulfur70FD1KFU70ACTIB
Sulfuric AcidO40UQP6WCFACTIB
ZincJ41CSQ7QDSACTIB
Apis Mellifera7S82P3R43ZACTIB
Thuja Occidentalis Leafy Twig1NT28V9397ACTIB
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
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact 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
AlcoholALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 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
AlcoholALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / NASAL20 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
AlcoholALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact 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
AlcoholALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact 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
f3047949-5e7a-5237-b6fa-2255dd2f681a931030b4-47e0-db78-37d5-445d88613ca12011-06-01WarningsExact identifier
spl id: f3047949-5e7a-5237-b6fa-2255dd2f681a
spl set id: 931030b4-47e0-db78-37d5-445d88613ca1

Reported adverse events (FAERS/openFDA)#

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