DR SHEFFIELD ATHLETES FOOT- clotrimazole cream

Dr Sheffield Athletes Foot by

Drug Labeling and Warnings

Dr Sheffield Athletes Foot 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

Clotrimazole 1 %

Purpose

Antifungal Cream

Uses

Cures athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis). Relieves the itching, irritation, 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.
• If irritation occurs or if there is not improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch), discontinue use and consult a doctor.

• Keep this and all drugs out of 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 this 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, pay special attention to the spaces between the toes; wear well-fitting, ventilated shoes, and 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 conditions persist longer, consult a doctor.
• This product is not effective on the scalp or nails.

Other information

• Store at controlled room temperature 68°-77°F (20°-25°C).
• Close cap tightly after use.

Inactive ingredients

Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Cetearyl Alcohol, Cetyl Esters, Octyldodecanol, Polysorbate 60, Sorbitan Monostearate, Tocopheryl Acetate, Purified Water.

Questions

1-800-222-1087

Principal Display Panel – 1.25oz Tube

Principal Display Panel – 1.25oz Tube

Dr. Sheffield's NDC: 11524-071-40

Athlete's
Foot Cream

Antifungal Cream

Clotrimazole 1%

Helps cure: Athlete's Foot Jock Itch Ringworm

Made in the USA

NET WT. 1.25 oz. (35.4g)

Principal Display Panel – 1.25oz Carton

Principal Display Panel – 1.25oz Carton

Dr. Sheffield's NDC: 11524-071-40

Athlete's
Foot Cream

Antifungal Cream

Clotrimazole 1%

Helps cure: Athlete's Foot Jock Itch Ringworm

Made in the USA

NET WT. 1.25 oz. (35.4g)

INGREDIENTS AND APPEARANCE

DR SHEFFIELD ATHLETES FOOT 
clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11527-071
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)	CLOTRIMAZOLE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYSORBATE 60 (UNII: CAL22UVI4M)
BENZYL ALCOHOL (UNII: LKG8494WBH)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
OCTYLDODECANOL (UNII: 461N1O614Y)
CETYL PALMITATE (UNII: 5ZA2S6B08X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11527-071-40	1 in 1 CARTON	10/04/2004
1		35.4 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	10/04/2004

Labeler - Sheffield Pharmaceuticals LLC (151177797)

Establishment
Name	Address	ID/FEI	Business Operations
Sheffield Pharmaceuticals LLC		151177797	MANUFACTURE(11527-071)