FDA.reportPublic FDA data

ProCure Antifungal

Manufacturer
Twin Med LLC
Effective date
2026-01-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:35:24

Label at a glance#

ProductProCure Antifungal
Active ingredientMICONAZOLE NITRATE
Label structure7 sections

Indications and uses

Uses: Proven clinically effective in the treatment of most Athlete's foot, jock itch and ring worm Relieves itching, scaling, cracking and discomfort that can accompany these conditions

Dosage and administration

Directions Cleanse affected area and dry thoroughly Apply thin layer to affected area twice daily (morning and night) or as directed by a physician Supervise children in the use of this product For athlete’s foot and ringworm, use daily for 4 weeks; for jock itch use daily for 2 weeks For athlete’s foot pay special attention to space between the toes; wear well-fitting, ventilated shoes and change shoes and socks ...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Miconazole Nitrate 2%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

Uses:

  • Proven clinically effective in the treatment of most Athlete's foot, jock itch and ring worm
  • Relieves itching, scaling, cracking and discomfort that can accompany these conditions

Warnings

WARNINGS SECTION

Warnings

For external use only

Do not use

OTC - DO NOT USE SECTION

Do not use on children under 2 years of age unless directed by a doctor

When using this product

OTC - WHEN USING SECTION

When using this product avoid contact with eyes

Stop using and ask a doctor if

OTC - STOP USE SECTION

Stop using and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks (for athlete’s foot or ringworm) or 2 weeks (for jock itch)

Keep out of reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of Children. In case of accidental ingestion, contact a physician or Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions

  • Cleanse affected area and dry thoroughly
  • Apply thin layer to affected area twice daily (morning and night) or as directed by a physician
  • Supervise children in the use of this product
  • For athlete’s foot and ringworm, use daily for 4 weeks; for jock itch use daily for 2 weeks
  • For athlete’s foot pay special attention to space between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily.
  • This product is not effective on the scalp or nails

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Cetostearyl Alcohol, Chlorocresol, Dibasic Sodium Phosphate, Edetate Disodium, Light Mineral Oil, Macrogol Cetostearyl Ether, Monobasic Sodium Phosphate Dihydrate, Propylene Glycol, Purified Water, White Petrolatum, Zinc Oxide

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PCAF ImagePCAF Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998483miconazole nitrate 2 % Topical CreamPSN2
998483miconazole nitrate 20 MG/ML Topical CreamSCD2
998483miconazole nitrate 2 % Topical CreamSY2

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeCode 128(01)10840330701232GTIN-14: 10840330701232
GTIN storage (14 digits): 10840330701232		PCAF04 Jan 2026.jpg

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55681-047-04ProCure Antifungal106 g in 1 TUBECREAM1062
55681-047-05ProCure Antifungal5 g in 1 PACKETCREAM52
55681-047-14ProCure Antifungal144 in 1 CARTONCREAM1442

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55681-04755681-047-04, 55681-047-05, 55681-047-14

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORMGR686LBA74IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE5QWK665956IACT
MICONAZOLE NITRATEVW4H1CYW1KACTIB
CHLOROCRESOL36W53O7109IACT
EDETATE DISODIUM7FLD91C86KIACT
LIGHT MINERAL OILN6K5787QVPIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
WHITE PETROLATUMB6E5W8RQJ4IACT
ZINC OXIDESOI2LOH54ZIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12025-08-25monthly-update2026-06-03 17:45:08

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
ProCure AntifungalMICONAZOLE NITRATE 2%Twin Med LLC3d380fe4-a870-cb55-e063-6394a90a9c902026-01-28WarningsExact identifier
ndc (package): 55681-047-14
ndc (package): 55681-047-05
ndc (package): 55681-047-04
ndc (product): 55681-047
ndc11 (package): 55681004704
ndc11 (package): 55681004714
ndc11 (package): 55681004705
spl id: 49758be2-d2d5-d4ad-e063-6294a90a9b03
spl set id: 3d380fe4-a870-cb55-e063-6394a90a9c90

Reported adverse events (FAERS/openFDA)#

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