Silka Athletes Foot Aerosol, Spray
FDA Label NDC 50066-084

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Genomma Lab Usa for the product Silka Athletes Foot (NDC 50066-084). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, otc - do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Active Ingredient

→ Purpose

→ Uses

→ Warnings

→ Otc - Do Not Use

→ When Using This Product

→ Stop Use And Ask A Doctor If

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions?

→ Principal Display Panel - 130 G Canister Label

Other

Drug Facts

Distributed by: Genomma Lab, Houston, TX 77098

Active Ingredient

Miconazole nitrate 2%

Purpose

Antifungal

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.

Warnings

For external use only.

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

Otc - Do Not Use

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

When Using This Product

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

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

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

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