Tolnaftate

Major Pharmaceuticals
Faria Limited dba Sheffield Pharmaceuticals

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active ingredient
• Purpose
• Tolnaftate Uses
• Warnings
  • Do not use
  • Stop use and ask a doctor if
  • Keep this and all drugs out of the reach of children.
• Directions
• Tolnaftate Other information
• Inactive ingredients
• Questions?
• Principal Display Panel – 0.5 oz Tube
• Principal Display Panel – 0.5 oz Carton

FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Tolnaftate USP 1%

Purpose

Antifungal

Uses

• for effective treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis)
• for effective relief of itchy, scaly skin between the toes
• clears up most athlete's foot infection and with daily use helps keep it from coming back

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 eyes

Stop use and ask a doctor if

• 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)

Keep this and all drugs out of the reach of children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

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

• use daily for 4 weeks. If condition persists longer, consult a doctor
• pay special attention to the spaces between the toes
• wear well fitting ventilated shoes
• change shoes and socks at least once daily

For ringworm, use daily for 4 weeks. If condition persists longer, consult a doctor.

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)
• Lot No. and Exp date: see crimp on tube or see box

Inactive ingredients

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

Questions?

Adverse Drug Event call (800)616-2471

Dist. By MAJOR PHARMACEUTICALS, 31778 Enterprise Drive, Livonia, MI 48150 USA

Re-Oder No. 100497 M-88 Rev. 9/09 Manufactured in USA

Principal Display Panel – 0.5 oz Tube

MAJOR ^® *Compare to Active Ingredient of Tinactin®

NDC 0904-0722-36

Antifungal

Cream (Tolnaftate 1%) N309040722362

CURES ATHLETE'S FOOT, *This product is not manufactured or

JOCK ITCH AND RINGWORM distributed by Schering-Plough Healthcare

Relives Burning and Itching Products, Inc. owner of the registered

• Odorless • Greaseless • Non-Staining trademark, Tinactin®

Net Wt. 0.5 OZ (14.18 g)