Silka Antifungal
FDA Label NDC 50066-083

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Genomma Lab Usa for the product Silka Antifungal (NDC 50066-083). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, otc - do not use, otc - when using, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Distributed by:
Genomma Lab., Houston, TX 77027

Active Ingredient

Tolnaftate 1%

Purpose

Antifungal

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.

Warnings

For external use only

Otc - Do Not Use

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

Otc - When Using

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).

Otc - Keep Out Of Reach Of Children

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

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.

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.

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

    Principal Display Panel (13 ML Bottle Carton)

    Principal Display Panel (13 ML Bottle Carton)

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