FDA.reportPublic FDA data

Premier Solutions Antifungal Miconazole Liquid Continuous Spray

Manufacturer
Premier Brands of America Inc.
Effective date
2025-11-03
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:41:52

Label at a glance#

ProductMiconazole nitrate
Active ingredientMICONAZOLE NITRATE
Label structure10 sections

Indications and uses

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

Dosage and administration

wash the affected area and dry thoroughly shake can well and spray a thin layer of the product 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 for athlete's foot and ringworm, use daily f...

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 itching, burning and scaling

Warnings

WARNINGS SECTION

For external use only.

Flammable:

SAFE HANDLING WARNING SECTION

Keep away from heat, sparks, and open flame. Contents under pressure.Do not puncture or incinerate. Do not store at temperature above 120ºF.

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 the affected area and dry thoroughly
  • shake can well and spray a thin layer of the product 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
  • for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
  • 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)

​Inactive ingredients

INACTIVE INGREDIENT SECTION

SD ALCOHOL 40-B, ETHOXYGLYCOL, PROPYLENE GLYCOL, ACETONE, TOCOPHERYL ACETATE

​ ​Questions?

OTC - QUESTIONS SECTION

call 1-866-964-0939

RECENT MAJOR CHANGES SECTION

.

​Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

premier ​

solutions

Antifungal

ATHLETE'S

FOOT

Continuous Liquid Spray

MICONAZOLE NITRATE 2% /

ANTIFUNGAL

CURES MOST
ATHLETE'S FOOT

Relieves itching, scaling & burning

Comforts & refreshes

SPRAYS AT ANY ANGLE

NET WT. 5.3 OZ. (150g)

cartoncarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998533miconazole nitrate 2 % Topical SprayPSN3
998533miconazole nitrate 20 MG/ML Topical SpraySCD3
998533miconazole nitrate 2 % Topical SpraySY3
998533miconazole nitrate 3 GM in 150 GM Topical SpraySY3

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-130034197007962GTIN-13: 0034197007962
EAN-13: 0034197007962
GTIN-12: 034197007962
UPC-A: 034197007962
GTIN storage (14 digits): 00034197007962		PS_Antifungal Miconazole Continuous Liquid Spray_50-069PS.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
56104-903-01Miconazole nitrate150 g in 1 CANAEROSOL, SPRAY1503

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
56104-90356104-903-01

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
ACETONE1364PS73AFIACT
ETHOXYDIGLYCOLA1A1I8X02BIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ALCOHOL3K9958V90MIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
MICONAZOLE NITRATEVW4H1CYW1KACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22025-06-20full-release2026-06-01 01:03:35

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 nitrateANTIFUNGAL MICONAZOLE LIQUID CONTINUOUS SPRAYPremier Brands of America Inc.3803c643-35d1-06d4-e063-6294a90ac6f62025-11-03WarningsExact identifier
ndc (package): 56104-903-01
ndc (product): 56104-903
ndc11 (package): 56104090301
spl id: 42b88029-f079-6b9e-e063-6294a90a8342
spl set id: 3803c643-35d1-06d4-e063-6294a90ac6f6

Reported adverse events (FAERS/openFDA)#

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