Tolnaftate Cream
FDA Label NDC 11527-051

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Sheffield Pharmaceuticals Llc for the product Tolnaftate (NDC 11527-051). 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 other, active ingredient, purpose, uses, warnings, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Active Ingredient

→ Purpose

→ Uses

→ Warnings

→ Directions

→ Other Information

→ Inactive Ingredients

→ Questions?

→ Principal Display Panel – 1.25 Oz Tube

→ Principal Display Panel – 1.25 Oz Carton

Other

Drug Facts

Active Ingredient

Tolnaftate USP 1%

Purpose

Antifungal Cream

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.

Inactive Ingredients

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

Questions?

1-800-222-1087

Principal Display Panel – 1.25 Oz Tube

Dr. Sheffield's NDC 11527-051-40

Antifungal Cream (Tolnaftate 1%) Made in the USA

CURES Most:

ATHLETE'S

FOOTJOCK ITCH

RINGWORM Net Wt. 1.25 OZ (35.4 g)

Principal Display Panel – 1.25 Oz Tube (Sheffield Antifungal Tube)

Principal Display Panel – 1.25 Oz Carton

Principal Display Panel – 1.25 Oz Carton (Sheffield Antifungal Cart)