Winco Antifungal Cream
FDA Label NDC 67091-051

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Winco Foods Llc for the product Winco Antifungal (NDC 67091-051). 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 active, purpose, uses, warnings, directions, other information, inactives, questions ?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active

Tolnaftate 1% 

Purpose

Antifungal 

Uses

  • Cures most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis).
  • Relieves the itching, irratation, redness, scaling and discomfort which can accompany these conditions.

Warnings

  • Do not use on children under 2 years of age unless directed by a doctor.
  • For external use only avoid contact with eyes.
  • Irritation occurs or if there is no improvement within 4 weeks (for athlete's foot and ringworm)irritation occurs or if there is no improvement within 2 weeks (for jock itch).

Directions

  • Clean the affected area and dry thoroughly.
  • Apply a thin layer of the product over the 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 the spaces between the toes.
    • Wear well fitting ventilated shoes.
    • Change shoes and socks at least once daily.
    • For athlete's foot and ringworm, use daily for 4 weeks.
    • For jock itch, use daily for 2 weeks.
    • If condition persists longer, consult a doctor.
    • This product is not effective on the scalp or nails.

Other Information

  • Store at controlled room temperature 15°-30°C (59°-86°F).
  • Close cap tighty after ever use.

Inactives

Ceteth-20, Cetostearyl Alcohol, Chlorocresol, Mineral Oil, White Petrolatum, Propylene Glycol, Sodium Phosphate Monobasic, Water

Questions ?

1-800-222-1087

Principal Display Panel -Carton

WINCO                                    NDC 67091-051-28

Antifungal Cream (Tolnaftate 1%) 

CURES Most:

ATHLETE'S

FOOTJOCK ITCH

RINGWORM

NET WT. 1.0 OZ (28 g)

557175_winco_1oz_tolnaftate_carton.jpg (557175 Winco 1oz Tolnaftate Carton)

557175_winco_1oz_tolnaftate_carton.jpg (557175 Winco 1oz Tolnaftate Carton)

Principal Display Panel -Tube

WINCO NDC 67091-051-28

Antifungal Cream (Tolnaftate 1%)

CURES Most:

ATHLETE'S

FOOTJOCK ITCH

RINGWORM

NET WT. 1.0 OZ (28 g)

255125_winco_1oz_tolnaftate_tube.jpg (255125 Winco 1oz Tolnaftate Tube)

255125_winco_1oz_tolnaftate_tube.jpg (255125 Winco 1oz Tolnaftate Tube)

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