FDA.reportPublic FDA data

Antifungal Cream

Manufacturer
Cardinal Health, Inc.
Effective date
2020-11-12
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 23:07:24

Label at a glance#

ProductAntifungal Cream
Active ingredientMICONAZOLE NITRATE
Label structure10 sections

Indications and uses

A clinically effective treatment for: most athlete's foot (tinea pedis) jock itch (tinea cruris) ringworm (tinea corporis) Relieves itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch

Dosage and administration

Glently cleanse the treatment area Pat dry Apply a thin layer of product to the affected area twice daily (morning and night) or as directed by a physician For athlete's foot, pay close attention to area between toes, wear well-fitting ventilated shoes, and change shoes and socks at least once daily Use daily for 4 weeks for treatment of athlete's foot and ringworm Use daily for 2 weeks for treamnet of jock itch I...

Label contents#

Full prescribing information#

Warnings

WARNINGS SECTION

  • For external use only
  • Avoid contact with eyes
  • Keep out of reach of children
  • If swallowed, get medical help or contact Poison Control Center right away
  • For athlete's foot and ringworm, if irritation occurs or there is no improvement within 4 weeks, discontinue use and consult a physician
  • For jock itch, if irritation occurs or there is no improvement within 2 weeks, discontinue use and consult a physician
  • Do not use on deep or puncture wounds, animal bites, serious burns, for diaper rash, on children younger tha 2 years of age.

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Miconazole Nitrate 2%       Antifungal

Uses

INDICATIONS & USAGE SECTION

A clinically effective treatment for:

  • most athlete's foot (tinea pedis)
  • jock itch (tinea cruris)
  • ringworm (tinea corporis)

Relieves itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch

Uses

OTC - PURPOSE SECTION

A clinically effective treatment for:

most athlete's foot (tinea pedis)jock itch (tinea cruris)ringworm (tinea corporis)

Relieves itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch

Directions

INSTRUCTIONS FOR USE SECTION

  • Glently cleanse the treatment area
  • Pat dry
  • Apply a thin layer of product to the affected area twice daily (morning and night) or as directed by a physician
  • For athlete's foot, pay close attention to area between toes, wear well-fitting ventilated shoes, and change shoes and socks at least once daily
  • Use daily for 4 weeks for treatment of athlete's foot and ringworm
  • Use daily for 2 weeks for treamnet of jock itch
  • If condition persists longer, consult a physician
  • This product is not effective on the scalp or nails

Directions

DOSAGE & ADMINISTRATION SECTION

Glently cleanse the treatment areaPat dryApply a thin layer of product to the affected area twice daily (morning and night) or as directed by a physicianFor athlete's foot, pay close attention to area between toes, wear well-fitting ventilated shoes, and change shoes and socks at least once dailyUse daily for 4 weeks for treatment of athlete's foot and ringwormUse daily for 2 weeks for treamnet of jock itchIf condition persists longer, consult a physicianThis product is not effective on the scalp or nails

Other Information

OTHER SAFETY INFORMATION

Store between 15-30oC (59-86oF)

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Allantoin, beeswax, cetyl dimethicone, cetyl PEG/PPG-10/1 dimethicone, dimethicone, disodium EDTA, fragrance, hydrogenated castor oil, isopropyl palmitate, methylparaben, petrolatum, propylene glycol, propylparaben, purified water, sodium chloride, zinc oxide

labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Antifungal Cream Artwork.jpgAntifungal Cream Artwork.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63517-009-042020-11-12C16284748780-19d75b9d0-b76a-f424-e053-dadaa90a57ceAntifungal Cream
63517-009-042020-01-31C16284748780-19d75b9d0-b76a-f424-e053-dadaa90a57ceAntifungal Cream

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
63517-00963517-009-04, 63517-009-05

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
MICONAZOLE NITRATEVW4H1CYW1KACTIB
WATER059QF0KO0RIACT
ALLANTOIN344S277G0ZIACT
EDETATE DISODIUM7FLD91C86KIACT
SODIUM CHLORIDE451W47IQ8XIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PETROLATUM4T6H12BN9UIACT
DIMETHICONE 1000MCU2324216IACT
CETYL DIMETHICONE 45IK315POC44IACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)035JKJ76MTIACT
PROPYLPARABENZ8IX2SC1OHIACT
WHITE WAX7G1J5DA97FIACT
HYDROGENATED CASTOR OILZF94AP8MEYIACT
ZINC OXIDESOI2LOH54ZIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
CUCUMBER FRUIT OILR81Y52NPCTIACT

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
b718b82d-bd49-4986-8c66-cfbece816a5723a53845-5f2f-45cd-9514-78fc885d491d2022-11-14WarningsExact identifier
spl set id: 23a53845-5f2f-45cd-9514-78fc885d491d

Reported adverse events (FAERS/openFDA)#

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