FDA.reportPublic FDA data

Silka Antifungal Foot

Manufacturer
Genomma Lab | CGI Packaging, LLC
Effective date
2019-01-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:33:37

Label at a glance#

ProductSilka Antifungal Foot
Active ingredientMICONAZOLE NITRATE
Label structure8 sections

Indications and uses

For the cure of most athlete's foot.

Dosage and administration

Clean the affected area and dry thoroughly. Apply a thin layer of the product over the 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 space between the toes; wear well-fitting, ventilated shoes and change socks at least once daily. Use daily for 4 weeks. If condition persists longer, consult a doctor. This product is...

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.

Warnings

WARNINGS SECTION

For external use only.

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

When using this product avoid contact with eyes.

Stop use and ask a doctor if irritation occurs or there is no improvement within 4 weeks.

Keep Out of Reach of Children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, seek 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 the 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 space between the toes; wear well-fitting, ventilated shoes and change socks at least once daily.
  • Use daily for 4 weeks.
  • If condition persists longer, consult a doctor.
  • This product is not effective on scalp and nails.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aldioxa, Cellulose, Chloroxylenol, Fragrance, Imidazolidynl Urea, Talc.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Front LabelFront LabelBack LabelBack Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50066-028-032022-09-22C16284748780-1ab0e2407-3310-f274-e053-dbdaa90a64717fac661e-403c-ae81-e053-2991aa0accd2
50066-028-032020-09-27C16284748780-1ab0e2407-3310-f274-e053-dbdaa90a64717fac661e-403c-ae81-e053-2991aa0accd2
50066-028-032020-09-25C16284748780-1ab0e2407-3310-f274-e053-dbdaa90a64717fac661e-403c-ae81-e053-2991aa0accd2
50066-028-032020-07-22C16284748780-1ab0e2407-3310-f274-e053-dbdaa90a64717fac661e-403c-ae81-e053-2991aa0accd2

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
50066-02850066-028-03

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
ALPHA CELLULOSEI355QGZ19AIACT
CHLOROXYLENOL0F32U78V2QIACT
IMIDUREAM629807ATLIACT
TALC7SEV7J4R1UIACT
MICONAZOLE NITRATEVW4H1CYW1KACTIB
ALDIOXA8T66I31YNKIACT

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
6dda49f3-1685-4736-bb6e-c29b2670c0d17fac661e-403c-ae81-e053-2991aa0accd22022-09-22WarningsExact identifier
spl set id: 7fac661e-403c-ae81-e053-2991aa0accd2

Reported adverse events (FAERS/openFDA)#

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