FDA.reportPublic FDA data

Jock Itch Powder

Manufacturer
Premier Brands of America Inc
Effective date
2024-12-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 20:46:47

Label at a glance#

ProductJock Itch Powder
Active ingredientMICONAZOLE NITRATE
Label structure9 sections

Indications and uses

for the cure of most athlete's foot, jock itch and ringworm

Dosage and administration

clean the affected area and dry thoroughly apply 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 jo...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Miconazole nitrate 2%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

for the cure of most athlete's foot, jock itch and ringworm

Warnings

WARNINGS SECTION

For external use only.

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 contact with the eyes

Stop and ask a doctor if

OTC - STOP USE SECTION

irritation occurs or there is no improvement within 4 weeks for athlete's foot and ringworm, or 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

  • clean the affected area and dry thoroughly
  • apply 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 longer, consult a doctor
  • this product is not effective on the scalp or nails

Other information

OTHER SAFETY INFORMATION

  • store between 59º - 86ºF
  • lightly shake bottle to loosen settled powder

Inactive ingredients

INACTIVE INGREDIENT SECTION

ZEA MAYS (CORN) STARCH, TRICALCIUM PHOSPHATE, MICOCRYSTALLINE CELLULOSE, SODIUM BICARBONATE, ALLANTOIN, CHLOROXYLENOL, FRAGRANCE

Questions?

OTC - QUESTIONS SECTION

call 1-866-964-0939

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

premier

solutions

TALC-FREE

JOCK ITCH

POWDER

MICONAZOLE NITRATE 2% /

ANTIFUNGAL

CURES MOST JOCK ITCH

Relieves itching, burning,

scaling & chafing

Absorbs moisture

NET WT. 2.5 OZ. (71 g)

cartoncarton

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
56104-901JOCK ITCH POWDER (MICONAZOLE NITRATE) POWDER [PREMIER BRANDS OF AMERICA INC]2Unmatched20241213_19afd603-ec2f-9e61-e063-6394a90ac4c2.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
56104-90156104-901-71

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
CHLOROXYLENOL0F32U78V2QIACT
SODIUM BICARBONATE8MDF5V39QOIACT
ALLANTOIN344S277G0ZIACT
MICONAZOLE NITRATEVW4H1CYW1KACTIB
TRICALCIUM PHOSPHATEK4C08XP666IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
STARCH, CORNO8232NY3SJIACT

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
380f5088-f39b-6711-e063-6294a90a60db19afd603-ec2f-9e61-e063-6394a90ac4c22025-06-21WarningsExact identifier
spl set id: 19afd603-ec2f-9e61-e063-6394a90ac4c2

Reported adverse events (FAERS/openFDA)#

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