Silka®

Silka®
SPL v1
SPL
SPL Set ID fb1dc636-837f-491c-97c1-e74288aebc27
Route
TOPICAL
Published
Effective Date 2025-09-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (1 g)
Inactive Ingredients
Aloe Vera Leaf Safflower Oil Hydrogenated Polyisobutene (1300 Mw) Lavender Oil Tea Tree Oil Rice Bran Oil Sesame Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-30

Description

Drug Facts

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Drug Facts

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.
Section 42229-5

Drug Facts

Section 50565-1

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

Section 50567-7

When using this product avoid contact with the eyes.

Section 50570-1
  • Do not use on children under 2 years of age unless directed by a doctor.
Warnings

For external use only

Directions
  • 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.
Active Ingredient

Tolnaftate 1%

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

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?

Call toll free 1-877-994-3666

Monday to Friday, 8 am to 6 pm Central time.

Stop Use and Ask A Doctor If
  • irritation occurs
  • there is no improvement within 4 weeks (for athlete's foot and ringworm).
Principal Display Panel 13 Ml Bottle Carton

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


Structured Label Content

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.
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50567-7 (50567-7)

When using this product avoid contact with the eyes.

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

Directions
  • 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.
Active Ingredient (Active ingredient)

Tolnaftate 1%

Other Information (Other information)
  • Store at room temperature 15° – 30°C (59° - 86°F)
Inactive Ingredients (Inactive ingredients)

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? (Questions or comments?)

Call toll free 1-877-994-3666

Monday to Friday, 8 am to 6 pm Central time.

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 and ringworm).
Principal Display Panel 13 Ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 13 ml Bottle Carton)

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


Advanced Ingredient Data


Raw Label Data

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