FDA.reportPublic FDA data

Cardinal Health Miconazole Antifungal Powder Spray - Talc-Free

Manufacturer
Cardinal Health
Effective date
2025-12-31
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-06-01 01:30:42

Label at a glance#

ProductMiconazole Nitrate
Active ingredientMICONAZOLE NITRATE
Label structure9 sections

Indications and uses

cures most athlete's foot (linea pedis), ringworm (linea corporis) and jock itch (linea cruris) relieves symptoms of athlete's foot, including itching, burning and cracking

Dosage and administration

wash affected area and dry thoroughly shake can well and spray a thin layer over 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 spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily use daily for 4 weeks for athlete's foot and ringworm; use dail...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Miconazole nitrate 2%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

  • cures most athlete's foot (linea pedis), ringworm (linea corporis) and jock itch (linea cruris)
  • relieves symptoms of athlete's foot, including itching, burning and cracking

WARNINGS SECTION

For external use only.

Flammable:

SAFE HANDLING WARNING SECTION

Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120ºF. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.

When using this product

OTC - WHEN USING SECTION

  • avoid contact with the eyes or mouth
  • use only as directed

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation occurs
  • no improvement within 4 weeks for athlete's foot and ringworm; 2 weeks for jock itch

Do not use

OTC - DO NOT USE SECTION

on children under 2 years of age unless directed by a doctor.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • wash affected area and dry thoroughly
  • shake can well and spray a thin layer over 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 spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
  • use daily for 4 weeks for athlete's foot and ringworm; use daily for 2 weeks for jock itch, if conditions persist, consult a doctor
  • this product is not effective on the scalp or nails
  • if nozzle clogs, clean with a pin

Other information

OTHER SAFETY INFORMATION

store between 20º and 30ºC (68ºF and 86º)

Inactive ingredients

INACTIVE INGREDIENT SECTION

disteardimonium hectorite, isobutane, kaolin, SD alcohol 40-B, zea mays (corn) starch

Questions?

OTC - QUESTIONS SECTION

call 1-866-964-0939

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER

Antifungal

Athlete's Foot

Powder Spray

Miconazole Nitrate 2% | Antifungal

Cures Most Athlete's Foot

Relieves Itching, Cracking

& Burning

Talc-Free

NET WT 4.6 OZ (130 g)

miconazole Powder Spraymiconazole Powder Spray

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998428miconazole nitrate 2 % Powder SprayPSN11
998428miconazole nitrate 0.02 MG/MG Powder SpraySCD11
998428miconazole nitrate 2 % Powder SpraySY11

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-130096295132748GTIN-13: 0096295132748
EAN-13: 0096295132748
GTIN-12: 096295132748
UPC-A: 096295132748
GTIN storage (14 digits): 00096295132748		Leader_AF Miconazole Powder Spray_50-140LD.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
70000-0321-1Miconazole Nitrate130 g in 1 CANPOWDER13011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0321-1GM - Gram70000-03211b1da4ad-5594-4eb8-bf5a-7e5489447b5e12018-03-08

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
70000-032170000-0321-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISOBUTANEBXR49TP611IACT
KAOLIN24H4NWX5COIACT
ALCOHOL3K9958V90MIACT
ZEA MAYS SUBSP. MAYS WHOLE1G5HNE09V8IACT
MICONAZOLE NITRATEVW4H1CYW1KACTIB
DISTEARDIMONIUM HECTORITEX687XDK09LIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
102025-12-11monthly-update2026-06-03 17:45:54
92025-10-08monthly-update2026-06-03 17:39:10
82024-11-01full-release2026-06-01 00:33:31

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
Miconazole NitrateANTI-FUNGAL POWDER MICONAZOLE NITRATE TALC FREECardinal Healthd90b210b-ade5-4b41-ad34-87f779cbb8ad2025-12-31WarningsExact identifier
ndc (package): 70000-0321-1
ndc (product): 70000-0321
ndc11 (package): 70000032101
spl id: 4743d4ad-c26e-38bd-e063-6394a90a7b31
spl set id: d90b210b-ade5-4b41-ad34-87f779cbb8ad

Reported adverse events (FAERS/openFDA)#

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