Tolnaftate by Major Pharmaceuticals / Sheffield Pharmaceuticals LLC TOLNAFTATE cream

Tolnaftate by

Drug Labeling and Warnings

Tolnaftate by is a Otc medication manufactured, distributed, or labeled by Major Pharmaceuticals, Sheffield Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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)

Principal Display Panel – 0.5 oz Carton

MAJOR® NDC: 0904-0722-36

Antifungal *Compare to Active Ingredient of Tinactin®

Cream

(Tolnaftate 1%) Net Wt. 0.5 OZ (14.18 g)

INGREDIENTS AND APPEARANCE

TOLNAFTATE 
tolnaftate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0904-0722
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV)	TOLNAFTATE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETETH-20 (UNII: I835H2IHHX)
CHLOROCRESOL (UNII: 36W53O7109)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0904-0722-36	1 in 1 CARTON	02/11/2010
1		14.18 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	02/11/2010

Labeler - Major Pharmaceuticals (191427277)

Registrant - Sheffield Pharmaceuticals LLC (151177797)

Establishment
Name	Address	ID/FEI	Business Operations
Sheffield Pharmaceuticals LLC		151177797	MANUFACTURE(0904-0722)