Silka®

Drug Facts

Composition & Product

Active Ingredients

Tolnaftate (10 mg)

Inactive Ingredients

Aloe Vera Leaf Safflower Oil Hydrogenated Polybutene (1300 Mw) Lavender Oil Tea Tree Oil Rice Bran Oil Sesame Oil

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2022-03-22

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

This product is not effective on the scalp or nails. For athlete's foot and ringworm: use daily for 4 weeks. Clean the affected area and dry thoroughly
Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor
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
To prevent athlete's foot, apply once or twice daily (morning and/or night)
Apply to skin around the nail and cuticle.

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

»
KILLS

FUNGUS
»
STOPS ITCHING

AND BURNING
»
HELPS RESTORE

SKIN HEALTH

BEFORE

AFTER

DRAMATIZATION

WITH BRUSH

APPLICATOR

CLINICALLY PROVEN

AGAINST ATHLETE'S

FOOT FUNGUS

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

This product is not effective on the scalp or nails. For athlete's foot and ringworm: use daily for 4 weeks. Clean the affected area and dry thoroughly
Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor
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
To prevent athlete's foot, apply once or twice daily (morning and/or night)
Apply to skin around the nail and cuticle.

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

»
KILLS

FUNGUS
»
STOPS ITCHING

AND BURNING
»
HELPS RESTORE

SKIN HEALTH

BEFORE

AFTER

DRAMATIZATION

WITH BRUSH

APPLICATOR

CLINICALLY PROVEN

AGAINST ATHLETE'S

FOOT FUNGUS

0.45 FL OZ / 13 ML

Advanced Ingredient Data

[{"name": "Tolnaftate", "unii": "06KB629TKV", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SAFFLOWER OIL", "unii": "65UEH262IS", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROGENATED POLYBUTENE (1300 MW)", "unii": "7D1YQ9Y5EZ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LAVENDER OIL", "unii": "ZBP1YXW0H8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TEA TREE OIL", "unii": "VIF565UC2G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "RICE BRAN OIL", "unii": "LZO6K1506A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SESAME OIL", "unii": "QX10HYY4QV", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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.", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50567-7": "When using this product avoid contact with the eyes.", "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": "This product is not effective on the scalp or nails. For athlete's foot and ringworm: use daily for 4 weeks. Clean the affected area and dry thoroughly Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor 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 To prevent athlete's foot, apply once or twice daily (morning and/or night) Apply to skin around the nail and cuticle.", "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 » KILLS FUNGUS » STOPS ITCHING AND BURNING » HELPS RESTORE SKIN HEALTH BEFORE AFTER DRAMATIZATION WITH BRUSH APPLICATOR CLINICALLY PROVEN AGAINST ATHLETE'S FOOT FUNGUS 0.45 FL OZ / 13 ML"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information