Silka Antifungal — v1

Silka Antifungal

3 Views

Version

v1

Effective date

September 30, 2025

Original packager

Yes

Sections captured

15

Identifiers

Document ID
9c9b657b-df37-4ee7-acd4-0f2ba98a891f
Set ID
fb1dc636-837f-491c-97c1-e74288aebc27
Application numbers
M005
Product NDCs
50066-085
Package NDCs
50066-085-01
Original packager NDCs

Names & Manufacturers

Brand names
Silka Antifungal
Generic names
TOLNAFTATE
Manufacturer names
Genomma Lab USA
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
TOLNAFTATE
Routes
TOPICAL
Pharmacologic class (PE)
Pharmacologic class (EPC)
Pharmacologic class (CS)
Mechanism of action

Other identifiers

NUI
RxCUI
UNII
06KB629TKV
UPC
0650240060458

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active ingredient Tolnaftate 1%
Do Not Use (1)

Sequence 1

Do not use on children under 2 years of age unless directed by a doctor.
Dosage And Administration (1)

Sequence 1

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.
Inactive Ingredient (1)

Sequence 1

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.
Indications And Usage (1)

Sequence 1

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.
Keep Out Of Reach Of Children (1)

Sequence 1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Package Label Principal Display Panel (1)

Sequence 1

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 PRINCIPAL DISPLAY PANEL - 13 ml Bottle Carton
Purpose (1)

Sequence 1

Purpose Antifungal
Questions (1)

Sequence 1

Questions or comments? Call toll free 1-877-994-3666 Monday to Friday, 8 am to 6 pm Central time.
Spl Product Data Elements (1)

Sequence 1

Silka Antifungal Tolnaftate Tolnaftate Tolnaftate ALOE VERA LEAF SAFFLOWER OIL HYDROGENATED POLYISOBUTENE (1300 MW) LAVENDER OIL TEA TREE OIL RICE BRAN OIL SESAME OIL
Spl Unclassified Section (2)

Sequence 1

Drug Facts

Sequence 2

Distributed by Genomma Lab., Houston, TX 77098
Stop Use (1)

Sequence 1

Stop use and ask a doctor if irritation occurs there is no improvement within 4 weeks (for athlete's foot and ringworm).
Storage And Handling (1)

Sequence 1

Other information Store at room temperature 15° – 30°C (59° - 86°F)
Warnings (1)

Sequence 1

Warnings For external use only Do not use on children under 2 years of age unless directed by a doctor. When using this product avoid contact with the eyes. Stop use and ask a doctor if irritation occurs there is no improvement within 4 weeks (for athlete's foot and ringworm). Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
When Using (1)

Sequence 1

When using this product avoid contact with the eyes.

OpenFDA raw payload

{'application_number': ['M005'],
 'brand_name': ['Silka Antifungal'],
 'generic_name': ['TOLNAFTATE'],
 'is_original_packager': [True],
 'manufacturer_name': ['Genomma Lab USA'],
 'package_ndc': ['50066-085-01'],
 'product_ndc': ['50066-085'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['TOPICAL'],
 'spl_id': ['9c9b657b-df37-4ee7-acd4-0f2ba98a891f'],
 'spl_set_id': ['fb1dc636-837f-491c-97c1-e74288aebc27'],
 'substance_name': ['TOLNAFTATE'],
 'unii': ['06KB629TKV'],
 'upc': ['0650240060458']}