TOLNAFTATE ANTIFUNGAL

MAJOR Pharmaceuticals Inc.
MAJOR Pharmaceuticals Inc.

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active Ingredients Section
• Purpose Section
• Keep Out of Reach of Children Section
• Indications and TOLNAFTATE ANTIFUNGAL Uses Section
• Warnings Section
• Dosage and Administration Section
• Inactive Ingredient Section
• Other Information Section
• Package Label Section

FULL PRESCRIBING INFORMATION

Active Ingredients Section

Drug Facts  Active Ingredient Tolnaftate 1 %

Purpose Section

Antifungal

Keep Out of Reach of Children Section

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Indications and Uses Section

Uses

for effective treatment of most athlete's foot (linea pedis), jock itch (tinea cruris) and ring worm (tiea corporis)

for effective relief of itchy, scaly skin between the toes

clears up most athlete's foot infection and with daily use helps to keep it from coming back

Warnings Section

Warnings

Do not use on children under 2 years of age.

Do not use for diaper rash.

For external use only

When using this product avoid contact with the eyes

Stop use and consult 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)

If swallowed, get medical help or contact a Poison Control Center right away.

Dosage and Administration Section

Directions: shake well before use

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   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 a daily    to prevent athlete's foot, clean and dry feet thoroughly.   Apply as above or twice daily

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

For jock itch    use daily for 2 weeks.   If condition persists longer, consuly a doctor.

This product is not effective on the scalp or nails.

Inactive Ingredient Section

Inactive ingredients

starch and talc

Other Information Section

Other information

Store between 2 degrees and 30 degrees C (36 degrees and 86 degrees F)

Package Label Section

NDC 0904-0726-45  TOLNAFTATE ANTIFUNGAL POWDER 1%

Cures Athlete's Foot Jock Itch Fungi and Ringworm    Compare to the active ingredient on Tinactin

MAJOR  net Wt. 45g (1 1/2 oz.)

MAJOR Pharmaceuticals is not affiliated  with the owner of the registered trademark Tinactin

Re-Order No. 0026   Rev 4/08    H002676  M-99

Distributed by MAJOR Pharmaceuticals  31778 Enterprise Drive, Livonia, MI 48150 USA

TO REPORT ADVERSE DRUG EVENTS CALL; 800-616-2471