Tolnaftate by Sheffield Pharmaceuticals LLC TOLNAFTATE cream

Tolnaftate by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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).

KEEP OUT OF REACH OF CHILDREN

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

• 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 Carton

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)

INGREDIENTS AND APPEARANCE

TOLNAFTATE 
tolnaftate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11527-051
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: 11527-051-40	1 in 1 CARTON	10/07/2009
1		35.4 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 11527-051-51	1 in 1 CARTON	10/07/2009
2		14 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	10/07/2009

Labeler - Sheffield Pharmaceuticals LLC (151177797)

Registrant - Sheffield Pharmaceuticals LLC (151177797)

Establishment
Name	Address	ID/FEI	Business Operations
Sheffield Pharmaceuticals LLC		151177797	MANUFACTURE(11527-051)