Silka

Manufacturer
Genomma Lab USA, Inc. | Taro Pharmaceuticals Inc.
Effective date
2024-12-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 20:46:42

Label at a glance#

ProductSilka Ringworm
Active ingredientCLOTRIMAZOLE
Label structure11 sections

Indications and uses

cures most ringworm relieves itching, redness, irritation and discomfort which accompany this condition

Dosage and administration

wash affected area and dry thoroughly apply a thin layer over affected area twice daily (morning and night) supervise children in the use of this product use daily for 4 weeks if condition persists longer, ask a doctor this product is not effective on the scalp or nails

Storage and handling

To open: unscrew cap, use the pointed end of cap to puncture seal. store between 20°- 25°C (68° - 77°F) see carton or tube crimp for lot number and expiration date

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Clotrimazole 1%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

  • cures most ringworm
  • relieves itching, redness, irritation and discomfort which accompany this condition

Warnings

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

When using this productavoid contact with the eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation occurs
  • there is no improvement within 4 weeks

OTC - DO NOT USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • wash affected area and dry thoroughly
  • apply a thin layer over affected area twice daily (morning and night)
  • supervise children in the use of this product
  • use daily for 4 weeks
  • if condition persists longer, ask a doctor
  • this product is not effective on the scalp or nails

Other information

STORAGE AND HANDLING SECTION

  • To open: unscrew cap, use the pointed end of cap to puncture seal.
  • store between 20°- 25°C (68° - 77°F)
  • see carton or tube crimp for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzyl alcohol (1%), cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sorbitan monostearate

Questions?

OTC - QUESTIONS SECTION

Call 1 877 99 GENOM (43666)

SPL UNCLASSIFIED SECTION

Distributed by:
Genomma Lab USA Inc., Houston, TX, 77027

PRINCIPAL DISPLAY PANEL - 14.2 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SILKA ®
Clotrimazole Cream USP, 1%
ANTIFUNGAL CREAM

CURES MOST RINGWORM

NET WT 0.5 oz (14.2 g)

Principal Display Panel - 14.2 g Tube Carton
Principal Display Panel - 14.2 g Tube Carton

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50066-11150066-111-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

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
2918130f-4a83-510a-e063-6394a90a9c4ac4e26aa4-248b-48f2-8cdb-630f094259f72024-12-12WarningsExact identifier
spl id: 2918130f-4a83-510a-e063-6394a90a9c4a
spl set id: c4e26aa4-248b-48f2-8cdb-630f094259f7

Reported adverse events (FAERS/openFDA)#

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