ATHLETES FOOT- clotrimazole cream

Athletes Foot by

Drug Labeling and Warnings

Athletes Foot by is a Otc medication manufactured, distributed, or labeled by Cardinal Health 110,Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Clotrimazole USP 1% w/w

Purpose

Antifungal Cream

Uses

Cures athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis). Relieves the itching, irritation, redness, scaling and chafing associated with jock itch.

Warnings

• Do not use on children under 2 years of age unless directed by a doctor.
• For external use only.
• Avoid contact with eyes.

Stop Use and ask a doctor 

• if irritation occurs or if there is no improvement within two weeks.

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

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

Directions

<This product is not effective on the scalp or nails.

• 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.
• use daily for 2 weeks.
• If conditions persists longer, consult a doctor.>

Other information

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

Inactive ingredients

aloe vera, benzyl alcohol, cetearyl alcohol, 2-octyldodecanol, polysorbate 60, sorbitan monostearate, spermwax, vitamin E, water

Questions?

For Questions or comments or to report an undesired reaction or side effect, please call 1-800-222-1222

Principal Display Panel – 1 oz. Tube

Leader       NDC: 70000-0493-1

CLOTRIMAZOLE 1%

ANTI-FUNGAL CREAM

 Cures Most Athlete's Foot NET WT. 0.5oz ( 14.2 g)

Compare to Lotramin

Principal Display Panel – 0.5 oz. Carton

Leader         NDC: 70000-0493-1

Cures Most

Athlete's Foot

Relieves Itching, Burning, Scaling, Discomfort and Chafing

CLOTRIMAZOLE 1% ANTI-FUNGAL CREAM

*Compare To the active ingredient in Lotrimin-AF®

NET WT. 0.5oz (14.2g)

INGREDIENTS AND APPEARANCE

ATHLETES FOOT 
clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0493
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: 70000-0493-1	1 in 1 CARTON	05/15/2019
1		28 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	05/15/2019

Labeler - Cardinal Health LLC (097537435)

Registrant - Sheffield Pharmaceuticals LLC (151177797)

Establishment
Name	Address	ID/FEI	Business Operations
Sheffield Pharmaceuticals LLC		151177797	MANUFACTURE(70000-0493)