Silka® - DailyMed Details

Silka®

SPL v1

SPL

SPL Set ID 307104a2-2df6-43b0-bf3f-f4d93d3e40f1

Route

TOPICAL

Published

Effective Date 2025-02-05

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Miconazole (20 mg)

Inactive Ingredients

Polysorbate 20 Alcohol 1-chloro-3,3,3-trifluoropropene

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-02-03

Description

Drug Facts

Purpose

Antifungal

Medication Information

Purpose

Antifungal

Description

Drug Facts

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.

Section 42229-5

Drug Facts

Section 50565-1

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

Section 50570-1

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

Warnings

For external use only.

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

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

Questions?

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

Active Ingredient

Miconazole nitrate 2%

Other Information

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

Inactive Ingredients

Alcohol Denat., polysorbate 20, tetrafluoropropene

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)

Principal Display Panel 130 G Canister Label

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)

Structured Label Content

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.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50570-1 (50570-1)

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

Purpose

Antifungal

Warnings

For external use only.

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

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

Questions?

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

Active Ingredient (Active ingredient)

Miconazole nitrate 2%

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

Alcohol Denat., polysorbate 20, tetrafluoropropene

When Using This Product (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 (Stop use and ask a doctor if)

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

Principal Display Panel 130 G Canister Label (PRINCIPAL DISPLAY PANEL - 130 g Canister Label)

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)

Advanced Ingredient Data

[{"name": "MICONAZOLE", "unii": "7NNO0D7S5M", "classCode": "ACTIB", "strengthNumerator": "20", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "POLYSORBATE 20", "unii": "7T1F30V5YH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "1-CHLORO-3,3,3-TRIFLUOROPROPENE", "unii": "4B96DT2BYB", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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.", "42229-5": "Drug Facts", "50565-1": "Keep out of the reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.", "50570-1": "Do not use on children under 2 years of age unless directed by a doctor.", "Purpose": "Antifungal", "Warnings": "For external use only. Flammable . Do not use while smoking or near heat or flame.", "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", "Questions?": "1-877-994-3666 Monday to Friday, 8am to 6pm Central time.", "Active ingredient": "Miconazole nitrate 2%", "Other information": "store between 20° to 25° (68° to 77°F)", "Inactive ingredients": "Alcohol Denat., polysorbate 20, tetrafluoropropene", "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)", "PRINCIPAL DISPLAY PANEL - 130 g Canister Label": "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)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:30.219136 · Updated: 2026-03-14T23:07:24.321893