Active Ingredient

Manufacturer
Twin Med LLC
Effective date
2026-08-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-08-06 06:10:23

Label at a glance#

ProductProCure Antifungal Cream
Active ingredientMICONAZOLE NITRATE
Label structure7 sections

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

Use

INDICATIONS & USAGE SECTION

Uses

  • Proven clinically effective in the treatment of most athlete's foot, jock itch and ringworm
  • 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

Caprylic/Capric Triglyceride, Ceteareth-20, Cetearyl Alcohol, Chlorocresol, Dimethicone, Disodium EDTA, Glyceryl Stearate, Imidazolidinyl Urea, PEG-100 Stearate, PEG-40 Castor Oil, Petrolatum, Propylene Glycol, Sodium Cetearyl Sulfate, Stearic Acid, Xanthan Gum, Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PCAF04 ImagePCAF04 Image

Product Linked Resources#

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

DailyMed Product Concepts#

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

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
55681-02355681-023-04, 55681-023-05, 55681-023-14

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

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12025-07-13full-release2026-06-01 01:07:13

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 Antifungal CreamMICONAZOLE NITRATE 2%Twin Med LLC39d55df5-8a8e-3a9b-e063-6294a90af20b2026-08-03WarningsExact identifier
ndc (package): 55681-023-04
ndc (package): 55681-023-05
ndc (package): 55681-023-14
ndc (product): 55681-023
ndc11 (package): 55681002305
ndc11 (package): 55681002304
ndc11 (package): 55681002314
spl id: 5828b30b-d1f1-9690-e063-6394a90ac037
spl set id: 39d55df5-8a8e-3a9b-e063-6294a90af20b

Reported adverse events (FAERS/openFDA)#

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