FDA.reportPublic FDA data

Premier Soutions Athlete's Foot Powder Spray

Manufacturer
Premier Brands of America Inc
Effective date
2026-06-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-06-04 05:10:10

Label at a glance#

ProductAthletes Foot
Active ingredientMICONAZOLE NITRATE
Label structure9 sections

Indications and uses

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

Warnings

WARNINGS SECTION

For external use only.

Extremely Flammable:

SAFE HANDLING WARNING SECTION

Keep away from fire, sparks, and heated surfaces. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F.

Do not use

OTC - DO NOT USE SECTION

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

When using this product

OTC - WHEN USING SECTION

  • avoid spraying in eyes
  • use only as directed
  • intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

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

Other information

OTHER SAFETY INFORMATION

  • store between 20º and 30ºC (68º and 86ºF)
  • if nozzle clogs, clean with a pin

Inactive ingredients

INACTIVE INGREDIENT SECTION

ISOBUTANE, SD ALCOHOL 40-B, KAOLIN, ZEA MAYS (CORN) STARCH, DISTEARDIMONIUM HECTORITE

Questions?

OTC - QUESTIONS SECTION

Call 1-866-964-0939

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

premier
solutions

Antifungal

ATHLETE'S
FOOT
Powder Spray

MICONAZOLE NITRATE 2% /
ANTIFUNGAL

CURES MOST
ATHLETE'S FOOT
Relieves itching, cracking & burning
Comforts & refreshes
Talc-free

NET WT. 4.6 OZ (130 g)

cartoncarton

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-130034197005364GTIN-13: 0034197005364
EAN-13: 0034197005364
GTIN-12: 034197005364
UPC-A: 034197005364
GTIN storage (14 digits): 00034197005364		PS_AF Miconazole Powder Spray_50-145PS 51826.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 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
56104-91256104-912-01

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
MICONAZOLE NITRATEVW4H1CYW1KACTIB
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
ISOBUTANEBXR49TP611IACT
KAOLIN24H4NWX5COIACT
ALCOHOL3K9958V90MIACT
ZEA MAYS (CORN) STARCHO8232NY3SJIACT

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
Athletes FootMICONAZOLE NITRATEPremier Brands of America Inc52d0909a-f404-0af4-e063-6394a90a3d0c2026-06-01WarningsExact identifier
ndc (package): 56104-912-01
ndc (product): 56104-912
ndc11 (package): 56104091201
spl id: 52d09bda-f8dc-11fe-e063-6394a90a84a4
spl set id: 52d0909a-f404-0af4-e063-6394a90a3d0c

Reported adverse events (FAERS/openFDA)#

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