FDA.reportPublic FDA data

Desenex

Manufacturer
Crown Laboratories
Effective date
2023-12-15
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
legacy-cache
Hydrated at
2026-08-01 21:18:04

Label at a glance#

ProductDesenex
Active ingredientMICONAZOLE NITRATE
Label structure9 sections

Indications and uses

cures most athlete’s foot (tinea pedis) relieves itching, burning, cracking, and discomfort associated with athlete’s foot

Dosage and administration

adults and children 2 years and older wash the affected area with soap and water and dry thoroughly before applying apply a thin layer over affected area twice a day (morning and night) or as directed by a doctor supervise children in the use of this product pay special attention to the spaces between the toes. Wear well-fitting, ventilated shoes and change shoes and socks at least once a day. use every day for 4 ...

Storage and handling

Store at 20 o - 25 o C (68 o - 77 o F) [see USP Controlled Room Temperature]. See container bottom for lot number and expiration date

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)
  • relieves itching, burning, cracking, and discomfort associated with athlete’s foot

Warnings

WARNINGS SECTION

For external use only · Avoid contact with eyes.

Do Not Use

OTC - DO NOT USE SECTION

  • for nail or scalp infections

When using this product

OTC - WHEN USING SECTION

  • do not get into the eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation occurs or gets worse
  • no improvement within 4 weeks

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

  • adults and children 2 years and older
  • wash the affected area with soap and water and dry thoroughly before applying
  • apply a thin layer over affected area twice a day (morning and night) or as directed by a doctor
  • supervise children in the use of this product
  • pay special attention to the spaces between the toes. Wear well-fitting, ventilated shoes and change shoes and socks at least once a day.
  • use every day for 4 weeks
  • children under 2 years of age: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • Store at 20 o - 25 oC (68 o - 77 oF) [see USP Controlled Room Temperature].
  • See container bottom for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aldioxa, Chloroxylenol, Croscarmellose Sodium, Fragrance, Imidazolidinyl Urea, Magnesium Stearate, Microcrystalline Cellulose, Sodium Acrylates Crosspolymer-2

Questions or comments?

OTC - QUESTIONS SECTION

call 1-833-279-6522

Principal Display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0316-0225-30

New & Improved

Desenex®

Miconazole Nitrate 2% Antifungal Treatment

PRESCRIPTION STRENGTH

TRIPLE ACTION POWDER

Absorbs Wetness

Repels Moisture

Relieves Itching & Burning

Cures Most Athlete's Foot

NET WT. 3 oz (85 g)

PRODUCT PACKAGED BY WEIGHT NOT VOLUME

©2020 Crown Laboratories, Inc.

Distributed by: Crown Laboratories, Inc. Johnson City, TN 37604

DESENEX is a registered trademark of Crown Laboratories, Inc.

P11528.01

desenexdesenex

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0316-0225DESENEX (MICONAZOLE NITRATE) POWDER [CROWN LABORATORIES]10Current NDC, Legacy NDC20231216_7c4a483e-199a-7ee1-e053-2a91aa0a3dec.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0316-0225-15GM - Gram0316-022501400da0-bdbd-4a2e-9de5-d2848d3a99ef12019-01-24
0316-0225-30GM - Gram0316-022541ddbc5d-8568-478a-a3a1-fdee93d77f5412019-01-24

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0316-02250316-0225-15, 0316-0225-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
CROSCARMELLOSE SODIUMM28OL1HH48IACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
CHLOROXYLENOL0F32U78V2QIACT
IMIDUREAM629807ATLIACT
ALDIOXA8T66I31YNKIACT
MICONAZOLE NITRATEVW4H1CYW1KACTIB
SODIUM ACRYLATES CROSSPOLYMER-2D3HPR4WW6FIACT

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DesenexMICONAZOLE NITRATECrown Laboratories09964187-12f1-bbe6-e063-6394a90acba02026-01-12WarningsExact identifier
ndc (product): 0316-0225
0c935646-fc62-0630-e063-6394a90acc577c4a483e-199a-7ee1-e053-2a91aa0a3dec2023-12-15WarningsExact identifier
spl id: 0c935646-fc62-0630-e063-6394a90acc57
spl set id: 7c4a483e-199a-7ee1-e053-2a91aa0a3dec

Reported adverse events (FAERS/openFDA)#

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