FDA.reportPublic FDA data

Silka ® Athlete's Foot Spray

Manufacturer
Genomma Lab USA
Effective date
2025-02-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:54:36

Label at a glance#

ProductSilka Athletes Foot
Active ingredientMICONAZOLE NITRATE
Label structure11 sections

Indications and uses

Clinically proven to be effective in the treatment of most athlete's foot (tinea pedis) Provides effective relief of itching, cracking, burning, scaling, and discomfort.

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) 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 this product is not effective on the scalp or nails

Storage and handling

store between 20° to 25° (68° to 77°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Miconazole nitrate 2%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

  • Clinically proven to be effective in the treatment of most athlete's foot (tinea pedis)
  • Provides effective relief of itching, cracking, burning, scaling, and discomfort.

Warnings

WARNINGS SECTION

For external use only.

Flammable. Do not use while smoking or near heat or flame.

OTC - DO NOT USE SECTION

Do not use on children under 2 years of age unless directed by a doctor.

When using this product

OTC - WHEN USING SECTION

  • Avoid contact with eyes
  • in case of contact with eyes, flush thoroughly with water
  • Avoid applying on broken skin
  • do not inhale or ingest
  • contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation occurs
  • there is no improvement within 4 weeks (for athlete's foot)

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children. If product is 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)
  • 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
  • this product is not effective on the scalp or nails

Other information

STORAGE AND HANDLING SECTION

  • store between 20° to 25° (68° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Alcohol Denat., polysorbate 20, tetrafluoropropene

Questions?

OTC - QUESTIONS SECTION

1-877-994-3666 Monday to Friday, 8am to 6pm Central time.

SPL UNCLASSIFIED SECTION

Distributed by: Genomma Lab, Houston, TX 77098

PRINCIPAL DISPLAY PANEL - 130 g Canister Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SILKA®
ATHLETE'S FOOT
POWDER SPRAY

Miconazole nitrate 2% - antifungal

CLINICALLY PROVEN TO CURE MOST
ATHLETE'S FOOT*

HELPS RELIEVE

  • BAD ODOR
  • ITCHING
  • SWEATING
  • BURNING

Net Wt 4.6oz (130g)

Principal Display Panel - 130 g Canister Label
Principal Display Panel - 130 g Canister Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998428miconazole nitrate 2 % Powder SprayPSN1
2704865SILKA 2 % Powder SprayPSN1
2704865miconazole nitrate 0.02 MG/MG Powder Spray [Silka Powder]SBD1
998428miconazole nitrate 0.02 MG/MG Powder SpraySCD1
998428miconazole nitrate 2 % Powder SpraySY1
2704865Silka Powder 0.02 MG/MG Powder SpraySY1
2704865Silka Powder 2 % Powder SpraySY1

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50066-084-46Silka Athletes Foot130 g in 1 CANISTERAEROSOL, SPRAY1301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50066-084SILKA ATHLETES FOOT (MICONAZOLE NITRATE) AEROSOL, SPRAY [GENOMMA LAB USA]1Current NDC, 1 package rows20250209_307104a2-2df6-43b0-bf3f-f4d93d3e40f1.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50066-08450066-084-46

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
MICONAZOLE NITRATEVW4H1CYW1KACTIB
POLYSORBATE 207T1F30V5YHIACT
ALCOHOL3K9958V90MIACT
1-CHLORO-3,3,3-TRIFLUOROPROPENE4B96DT2BYBIACT

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
Silka Athletes FootMICONAZOLE NITRATEGenomma Lab USA307104a2-2df6-43b0-bf3f-f4d93d3e40f12025-02-05WarningsExact identifier
ndc (package): 50066-084-46
ndc (product): 50066-084
ndc11 (package): 50066008446
spl id: c55dd887-1f9e-4ffc-a6a7-2ca1fa7d5407
spl set id: 307104a2-2df6-43b0-bf3f-f4d93d3e40f1

Reported adverse events (FAERS/openFDA)#

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