DERMAFUNGAL

Manufacturer
DermaRite industries, LLC | Fabian McCarthy
Effective date
2024-12-05
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 00:40:52

Label at a glance#

ProductDERMAFUNGAL
Active ingredientMICONAZOLE NITRATE
Label structure9 sections

Indications and uses

For the treatment and prevention of most: athlete's foot, jock itch, ringworm relieves itching, scaling,cracking, and discomfort associated with these conditions.

Dosage and administration

Cleanse affected area and dry thoroughly. Apply a thin layer to affected area twice daily or as directed by physician. For jock itch use daily for two weeks. For athelete's foot use daily for four weeks.

Label contents#

Full prescribing information#

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Miconazole Nitrate 2%

Purpose:

OTC - PURPOSE SECTION

Antifungal

Uses:

INDICATIONS & USAGE SECTION

  • For the treatment and prevention of most: athlete's foot, jock itch, ringworm
  • relieves itching, scaling,cracking, and discomfort associated with these conditions.

Warnings:

WARNINGS SECTION

  • For external use only.
  • Avoid contact with eyes. In case of contact, flush thoroughly with water.
  • Stop use and ask doctor if irritation occurs , condition worsens or does not improve in 2 weeks for jock itch, or within 4 weeks for athlete's foot and ringworm.

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children. In case of accidental ingestion contact physician or Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Cleanse affected area and dry thoroughly. Apply a thin layer to affected area twice daily or as directed by physician.

  • For jockitch use daily for two weeks.
  • For athelete's foot use daily for four weeks.

Other Information:

INFORMATION FOR OWNERS/CAREGIVERS SECTION

  • This product is not effective on the scalp and nails.
  • Store at room temperature (59°-86°F)

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Caprylic/Capric Triglyceride, Ceteareth-20, Disodium EDTA, Glyceryl Stearate, Methylparaben, PEG-40 Castor Oil, PEG-100 Stearate, Petrolatum, Propylene Glycol, Propylparaben, Stearic Acid, Water, Xantham Gum

Durmafungal Principal Display Panel and Drug Facts

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DermaFungalDermaFungal

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
MICONAZOLE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61924-234-04DERMAFUNGAL106 g in 1 TUBECREAM1069
61924-234-05DERMAFUNGAL5 g in 1 PACKETCREAM59

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61924-234DERMAFUNGAL (ANTIMICROBIAL DRUG PRODUCTS) CREAM [DERMARITE INDUSTRIES, LLC]9Legacy NDC, 2 package rows20241208_4e7739a1-cff0-4b76-94f0-d9f9af158df5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61924-234-04GM - Gram61924-234f971cbea-9b8b-4a5b-83c5-5f3f156c472a12014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Miconazole NitrateACTIVE INGREDIENTVW4H1CYW1K1
MICONAZOLEACTIVE MOIETY7NNO0D7S5M1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1S1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE41
IMIDUREAINACTIVE INGREDIENTM629807ATL1
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7U1
MethylparabenINACTIVE INGREDIENTA2I8C7HI9T1
PEG-100 StearateINACTIVE INGREDIENTYD01N1999R1
PEG-40 Castor OilINACTIVE INGREDIENT4ERD2076EF1
PetrolatumINACTIVE INGREDIENT4T6H12BN9U1
POLYOXYL 20 CETOSTEARYL ETHERINACTIVE INGREDIENTYRC528SWUY1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V31
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OH1
Stearic AcidINACTIVE INGREDIENT4ELV7Z65AP1
WaterINACTIVE INGREDIENT059QF0KO0R1
Xanthan GumINACTIVE INGREDIENTTTV12P4NEE1

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61924-23461924-234-05, 61924-234-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

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 8 · 440 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SSPRAY / TOPICAL1 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii candidate
79 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7USPRAY / TOPICAL540 mgExact identifier — unii candidate
18 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KENEMA / RECTAL60 mgExact identifier — unii candidate
77 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TDROPS / NASAL26 mgExact identifier — unii candidate
79 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INTRALESIONAL0.05 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4AEROSOL, FOAM / TOPICAL3.27 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9UOINTMENT / OPHTHALMIC88.4 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL36 mgExact identifier — unii candidate
29 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CAPSULE, DELAYED RELEASE / ORAL15 mgExact identifier — unii candidate
21 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHINJECTION / INTRAVENOUS6 mgExact identifier — unii candidate
68 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TINJECTION / SUBCUTANEOUS22 mgExact identifier — unii candidate
79 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SCREAM / TOPICAL1428 mgExact identifier — unii candidate
9 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHLIQUID / ORAL2 mgExact identifier — unii candidate
68 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLIQUID / INTRAVENOUS0.03 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TPOWDER, FOR SUSPENSION / ORAL75 mgExact identifier — unii candidate
79 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TINJECTION, SUSPENSION / SUBCUTANEOUS0.16 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHSUSPENSION / SUBCUTANEOUS0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3LIQUID / ORAL29008 mgExact identifier — unii candidate
81 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHOINTMENT / TOPICAL0.2 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TINJECTION / SOFT TISSUE0.15 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHELIXIR / ORAL200 mgExact identifier — unii candidate
68 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHINJECTION / PARENTERAL2 mgExact identifier — unii candidate
68 equally ranked IID candidates
POLYOXYL 20 CETOSTEARYL ETHERPOLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYLOTION / TOPICAL71 mgExact identifier — unii candidate
7 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHINJECTION / INTRAMUSCULAR6 mgExact identifier — unii candidate
68 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APTABLET / SUBLINGUAL9 mgExact identifier — unii candidate
26 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSOLUTION / IRRIGATION2 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APTABLET / BUCCAL6 mgExact identifier — unii candidate
26 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APEMULSION / ORALNAExact identifier — unii candidate
26 equally ranked IID candidates
Stearic AcidSTEARIC ACID4ELV7Z65APCAPSULE, EXTENDED RELEASE / ORAL64 mgExact identifier — unii candidate
26 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TELIXIR / ORAL800 mgExact identifier — unii candidate
79 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INTRAMUSCULAR10 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION, EXTENDED RELEASE / ORAL40 mgExact identifier — unii candidate
77 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEESUSPENSION / RECTAL452 mgExact identifier — unii candidate
29 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3CAPSULE, DELAYED RELEASE / ORAL1.7 mgExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION, CONCENTRATE / ORAL2590 mgExact identifier — unii candidate
81 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM / TOPICAL14 mgExact identifier — unii candidate
77 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii candidate
81 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEEENEMA / RECTAL150 mgExact identifier — unii candidate
29 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLOTION / TOPICAL22 mgExact identifier — unii candidate
77 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / AURICULAR (OTIC)10 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSYSTEM / TOPICAL126 mgExact identifier — unii candidate
77 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3CONCENTRATE / ORAL7000 mgExact identifier — unii candidate
81 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UAEROSOL, FOAM / TOPICAL10.87 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / NASAL100 mg/100mlExact identifier — unii candidate
77 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3GEL / RECTAL3315 mgExact identifier — unii candidate
81 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / OPHTHALMIC4 mgExact identifier — unii candidate
77 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / VAGINAL6.4 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION/ DROPS / TOPICAL0.75 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
IMIDUREAIMIDUREAM629807ATLCREAM / TOPICAL0.4 %w/wExact identifier — unii candidate
3 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, SOLUTION / INTRAVENOUS7 mgExact identifier — unii candidate
77 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHINJECTION, SOLUTION / INTRAMUSCULAR5 mgExact identifier — unii candidate
68 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION/ DROPS / ORAL4 mgExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4TABLET / SUBLINGUAL1.23 mgExact identifier — unii candidate
21 equally ranked IID candidates
PetrolatumPETROLATUM4T6H12BN9UTABLET / ORAL3.5 mgExact identifier — unii candidate
18 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDESMEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UTABLET, ORALLY DISINTEGRATING / ORAL1 mgExact identifier — unii candidate
18 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / RESPIRATORY (INHALATION)43 mgExact identifier — unii candidate
77 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / AURICULAR (OTIC)56.55 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
Xanthan GumXANTHAN GUMTTV12P4NEELOZENGE / ORAL1264 mgExact identifier — unii candidate
29 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TINJECTION / PARENTERAL18 mgExact identifier — unii candidate
79 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
288802cd-338c-cead-e063-6394a90a6edf4e7739a1-cff0-4b76-94f0-d9f9af158df52024-12-05WarningsExact identifier
spl id: 288802cd-338c-cead-e063-6394a90a6edf
spl set id: 4e7739a1-cff0-4b76-94f0-d9f9af158df5

Reported adverse events (FAERS/openFDA)#

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