FDA.reportPublic FDA data

Premier Solutions Antifungal Miconazole Powder Spray

Manufacturer
Premier Brands of America Inc.
Effective date
2024-10-14
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 20:52:39

Label at a glance#

ProductAntifungal Miconazole
Active ingredientMICONAZOLE NITRATE
Label structure9 sections

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 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 fo...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Miconozole nitrate 2%

Purpose

OTC - PURPOSE SECTION

Antifungal

INDICATIONS & USAGE SECTION

Uses

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

Warnings

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 120°F. Intentional misuse by deliberately concentrationg 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 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 condition persists, consult a doctor
  • this product is not effective on scalp or nails
  • if nozzle clogs, clean with a pin

Other infomation

OTHER SAFETY INFORMATION

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

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

Athlete's Foot Antifungal Powder Spray

Miconazole Nitrate 2%/

ANTIFUNGAL

Cures Most Athelete's Foot

Relieves Itching, Cracking & Burning

Talc Free

NET WT. 4.6 OZ (130g)

image 1image 1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
56104-256ANTIFUNGAL MICONAZOLE (MICONAZOLE NITRATE) AEROSOL, SPRAY [PREMIER BRANDS OF AMERICA INC.]4Legacy NDC20241016_ec801b6b-7787-a1aa-e053-2995a90a3233.zip

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
56104-25656104-256-01

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
ISOBUTANEBXR49TP611IACT
ALCOHOL3K9958V90MIACT
MICONAZOLE NITRATEVW4H1CYW1KACTIB
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
ZEA MAYS SUBSP. MAYS WHOLE1G5HNE09V8IACT
KAOLIN24H4NWX5COIACT

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
3bba4bbf-d6f9-dd57-e063-6294a90a7538ec801b6b-7787-a1aa-e053-2995a90a32332025-08-06WarningsExact identifier
spl set id: ec801b6b-7787-a1aa-e053-2995a90a3233

Reported adverse events (FAERS/openFDA)#

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