ProCure Antifungal

Manufacturer
Twin Med LLC
Effective date
2025-12-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:18:45

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 ringworm Relieves itching, scaling, cracking, burning, redness, soreness, irritation, and discomforts associated with all three treatments. Also relieves chaffing associated with jock itch.

Dosage and administration

Directions clean affected area and dry thoroughly apply thin layer of powder to affected area twice daily (morning and night) or as directed by a doctor supervise children in the use of this product 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. for athlete’s foot and ringworm, use daily for 4 weeks; for jock i...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Mconazole 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 ringworm
  • Relieves itching, scaling, cracking, burning, redness, soreness, irritation, and discomforts associated with all three treatments. Also relieves chaffing associated with jock itch.

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

  • clean affected area and dry thoroughly
  • apply thin layer of powder to affected area twice daily (morning and night) or as directed by a doctor
  • supervise children in the use of this product
  • 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.
  • for athlete’s foot and ringworm, use daily for 4 weeks; for jock itch use daily for 2 weeks
  • if condition persists longer, consult a doctor
  • this product is not effective on the scalp or nails

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Colloidal Silicon Dioxide, Corn Starch, Dipotassium Glycyrrhizinate, Sodium Benzoate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Antifungal Powder ImageAntifungal Powder Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998461miconazole nitrate 2 % Topical PowderPSN1
998461miconazole nitrate 0.02 MG/MG Topical PowderSCD1
998461miconazole nitrate 2 % Topical PowderSY1

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
BarcodeEAN-130816516015632GTIN-13: 0816516015632
EAN-13: 0816516015632
GTIN-12: 816516015632
UPC-A: 816516015632
GTIN storage (14 digits): 00816516015632
Antifungal Powder Image.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
55681-043-03ProCure Antifungal85 g in 1 BOTTLEPOWDER851

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55681-04355681-043-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 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
ProCure AntifungalMICONAZOLE NITRATE 2%Twin Med LLC3d375325-ddad-f1e1-e063-6394a90a679f2025-12-01WarningsExact identifier
ndc (package): 55681-043-03
ndc (product): 55681-043
ndc11 (package): 55681004303
spl id: 3d375325-ddae-f1e1-e063-6394a90a679f
spl set id: 3d375325-ddad-f1e1-e063-6394a90a679f

Reported adverse events (FAERS/openFDA)#

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