FDA.reportPublic FDA data

Silka Antifungal

Manufacturer
Genomma Lab USA
Effective date
2025-09-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:15:23

Label at a glance#

ProductSilka Antifungal
Active ingredientTolnaftate
Label structure11 sections

Indications and uses

For effective treatment of most athlete's foot and ringworm Relieves itching, scaling, cracking, burning, redness, soreness, irritation and discomfort. Helps prevent most athlete's foot (dermatophytosis) with daily use.

Dosage and administration

Clean affected area with soap and warm water and dry thoroughly. Apply a thin layer of Silka® Anti-Fungal Liquid over affected area twice daily (morning and night) or as directed by a doctor. The brush applicator allows for easy application on skin around the nail and cuticle area. Wear well-fitting, ventilated shoes, and change shoes and socks at least once daily. For athlete's foot: pay special attention to space...

Storage and handling

Store at room temperature 15° – 30°C (59° - 86°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Tolnaftate 1%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

  • For effective treatment of most athlete's foot and ringworm
  • Relieves itching, scaling, cracking, burning, redness, soreness, irritation and discomfort. Helps prevent most athlete's foot (dermatophytosis) with daily use.

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

When using this product avoid contact with the eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

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

  • Clean affected area with soap and warm water and dry thoroughly. Apply a thin layer of Silka® Anti-Fungal Liquid over affected area twice daily (morning and night) or as directed by a doctor. The brush applicator allows for easy application on skin around the nail and cuticle area.
  • Wear well-fitting, ventilated shoes, and change shoes and socks at least once daily. For athlete's foot: pay special attention to spaces between the toes.
  • For athlete's foot and ringworm, use daily for 4 weeks. For toe fungus, apply under nail and around cuticle area. If condition persists longer, consult a doctor.
  • This product is not effective on the scalp or nails.
  • Supervise children in the use of this product.

Other information

STORAGE AND HANDLING SECTION

  • Store at room temperature 15° – 30°C (59° - 86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Extract, BHT, Carthamus Tinctorius (Safflower) Seed Oil, Hydrogenated Polyisobutene, Lavandula Angustifolia (Lavender) Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Oryza Sativa (Rice) Bran Oil, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Sesamum Indicum (Sesame) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Tocopheryl Acetate.

Questions or comments?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

Distributed by
Genomma Lab., Houston, TX 77098

PRINCIPAL DISPLAY PANEL - 13 ml Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SILKA®

MAX STRENGTH
ANTIFUNGAL LIQUID

CLINICALLY PROVEN

AGAINST ATHLETE'S
FOOT FUNGUS

  • KILLS FUNGUS
  • STOPS ITCHING
    AND BURNING
  • HELPS RESTORE
    SKIN HEALTH

with brush
APPLICATOR

BEFORE
AFTER
DRAMATIZATION

0.45 fl oz / 13 ml

PRINCIPAL DISPLAY PANEL - 13 ml Bottle Carton
PRINCIPAL DISPLAY PANEL - 13 ml Bottle Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313423tolnaftate 1 % Topical SolutionPSN1
313423tolnaftate 10 MG/ML Topical SolutionSCD1
313423tolnaftate 1 % Topical SolutionSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50066-085-01Silka Antifungal13 mL in 1 BOTTLE, GLASSLIQUID131
50066-085-01Silka Antifungal1 in 1 CARTONLIQUID11

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
50066-08550066-085-01

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
Tolnaftate06KB629TKVACTIB
ALOE VERA LEAFZY81Z83H0XIACT
SAFFLOWER OIL65UEH262ISIACT
HYDROGENATED POLYISOBUTENE (1300 MW)7D1YQ9Y5EZIACT
LAVENDER OILZBP1YXW0H8IACT
TEA TREE OILVIF565UC2GIACT
RICE BRAN OILLZO6K1506AIACT
SESAME OILQX10HYY4QVIACT

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 AntifungalTOLNAFTATEGenomma Lab USAfb1dc636-837f-491c-97c1-e74288aebc272025-09-30WarningsExact identifier
ndc (package): 50066-085-01
ndc (product): 50066-085
ndc11 (package): 50066008501
spl id: 9c9b657b-df37-4ee7-acd4-0f2ba98a891f
spl set id: fb1dc636-837f-491c-97c1-e74288aebc27

Reported adverse events (FAERS/openFDA)#

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