FDA.reportPublic FDA data

Desenex Antifungal Foot Cream

Manufacturer
Crown Laboratories, Inc.
Effective date
2026-01-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:32:28

Label at a glance#

ProductDesenex Antifungal Foot Cream
Active ingredientMICONAZOLE NITRATE
Label structure10 sections

Indications and uses

Cures most athlete's foot (tinea pedis) Relieves ithcing, burning, cracking, scaling, and discomfort

Dosage and administration

Wash 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. Pay special attention to spaces between the toes; wear well-fiting, ventilated shoes, and change shoes and socks at least once daily. Use daily for 4 weeks. If condition persists longer consult a doctor. This produ...

Storage and handling

store at 20°–25°C (68°–77°F) [see USP Controlled Room Temperature].

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 ithcing, burning, cracking, scaling, and discomfort

Warnings

WARNINGS SECTION

For external use only.

Avoid contact with eyes.

Do not use

OTC - DO NOT USE SECTION

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

Stop use

OTC - STOP USE SECTION

if irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult 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 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.
  • Pay special attention to spaces between the toes; wear well-fiting, ventilated shoes, and change shoes and socks at least once daily.
  • Use daily for 4 weeks. If condition persists longer consult a doctor.
  • This product is not effective on the scalp or nails.

Other information

STORAGE AND HANDLING SECTION

  • store at 20°–25°C (68°–77°F) [see USP Controlled Room Temperature].

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua, Benzyl Benzoate, Cetearyl Alcohol, Cetyl Palmitate, Dipropylene Glycol, Fragrance, Paraffinum Liquidum, Polysorbate 60, Potassium Sorbate, Propylene Glycol, Sorbic Acid, Sorbitol, Triethyl Citrate

Questions?

OTC - QUESTIONS SECTION

call 1-833-279-6522

Desenex Cream Tube

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Desenex

Antifungal Foot Cream

with 2% Miconazole Nitrate

PRESCRIPTION STRENGTH

Cures Most Athlete's Foot

Dual Action Cream

Relieves Itching, Burning, Scaling, and Discomfort

Patented Odor Control Technology

Clean Fresh Scent

NET WT. 1oz (28g)

Distributed by: Crown Laboratories, Inc. Johnson City, TN 36704

P12801.00

Desenex tubeDesenex tube

Desenex Cream Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Desenex

Antifungal Foot Cream

with 2% Miconazole Nitrate

PRESCRIPTION STRENGTH

Cures Most Athlete's Foot

Dual Action Cream

Relieves Itching, Burning, Scaling, and Discomfort

Patented Odor Control Technology

Clean Fresh Scent

NET WT. 1oz (28g)

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

Desenex is a registered trademark of Crown Laboratories, Inc.

P12802.00

Desenex cartonDesenex carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2709228Desenex 2 % Topical CreamPSN2
998483miconazole nitrate 2 % Topical CreamPSN2
2709228miconazole nitrate 20 MG/ML Topical Cream [Desenex]SBD2
998483miconazole nitrate 20 MG/ML Topical CreamSCD2
2709228Desenex 20 MG/ML Topical CreamSY2
998483miconazole nitrate 2 % Topical CreamSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
MICONAZOLE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0316-0255-01Desenex Antifungal Foot Cream1 in 1 CARTONCREAM12
0316-0255-01Desenex Antifungal Foot Cream28 g in 1 TUBECREAM282

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0316-0255-01GM - Gram0316-0255be4c23a7-c1b5-42a0-a237-eed85396d47d12025-05-14

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0316-02550316-0255-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
PARAFFINUM LIQUIDUMT5L8T28FGPIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
CETYL PALMITATE5ZA2S6B08XIACT
DIPROPYLENE GLYCOLE107L85C40IACT
MICONAZOLE NITRATEVW4H1CYW1KACTIB
TRIETHYL CITRATE8Z96QXD6UMIACT
SORBIC ACIDX045WJ989BIACT
SORBITOL506T60A25RIACT
BENZYL BENZOATEN863NB338GIACT
POLYSORBATE 60CAL22UVI4MIACT
CETEARYL ALCOHOL2DMT128M1SIACT

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
Desenex Antifungal Foot CreamMICONAZOLE NITRATECrown Laboratories, Inc.311abb56-e176-0510-e063-6294a90a97f52026-01-12WarningsExact identifier
ndc (package): 0316-0255-01
ndc (product): 0316-0255
ndc11 (package): 00316025501
spl id: 48346f3b-72c9-a271-e063-6394a90a9238
spl set id: 311abb56-e176-0510-e063-6294a90a97f5

Reported adverse events (FAERS/openFDA)#

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