Fungal

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 02:13:47

Label at a glance#

ProductFungal
Active ingredientSILICON DIOXIDE, SULFUR, SULFURIC ACID, ZINC, APIS MELLIFERA, THUJA OCCIDENTALIS LEAFY TWIG, CANDIDA 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
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Formulated for symptoms associated with jock itch, athlete's foot, thrush and ringworm such as itching, skin changes and redness.

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) as needed or as directed by a health professional.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Apis mel. 6x, Phytolacca 6x, Thuja occ. 6x, Antimon. crud. 15x, Arsenicum alb. 15x, Baryta carb. 15x, Bryonia 15x, Calc. carb.15x, Candida alb. 15x, Carbo veg. 15x, Cuprum met. 15x, Dulcamara 15x, Graphites 15x, Kali carb. 15x, Lachesis 15x, Lycopodium 15x, Mezereum 15x, Nitricum ac. 15x, Phos. 15x, Phytolacca 15x, Sepia 15x, Silicea 15x, Sulphur 15x, Sulphuricum ac. 15x, Zinc. met. 15x, Sanicula 16x, Tellurium 16x, Torula cerevisiae 16x.

OTC - PURPOSE SECTION

Formulated for symptoms associated with jock itch, athlete's foot, thrush and ringworm such as itching, skin changes and redness.

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 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-4788-1Fungal30 mL in 1 BOTTLE, GLASSLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4788FUNGAL (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 OCC.) LIQUID [NEWTON LABORATORIES, INC.]2Current NDC, Legacy NDC, 1 package rows20201204_99487f4a-76f6-407b-e053-2a95a90acfd4.zip

Products#

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

DailyMed product names page 1 of 1 · 34 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-478855714-4788-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

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
FungalCANDIDA 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 OCC.Newton Laboratories, Inc.99487f4a-76f6-407b-e053-2a95a90acfd42020-12-03WarningsExact identifier
ndc (package): 55714-4788-1
ndc (product): 55714-4788
ndc11 (package): 55714478801
spl id: b592c526-4f77-c676-e053-2995a90ae63b
spl set id: 99487f4a-76f6-407b-e053-2a95a90acfd4

Reported adverse events (FAERS/openFDA)#

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