CLOTRIMAZOLE ATHLETES FOOT- clotrimazole cream

Clotrimazole by

Drug Labeling and Warnings

Clotrimazole by is a Otc medication manufactured, distributed, or labeled by Kaiser Foundation Hospitals, Taro Pharmaceuticals U.S.A., Inc., Taro Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Clotrimazole 1%

Purpose

Antifungal

Uses

• cures most athlete's foot, jock itch and ringworm
• relieves itching, burning, cracking, scaling and discomfort which accompany these conditions

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
• there is no improvement within 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch).

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• wash affected area and dry thoroughly
• apply a thin layer over affected area twice daily (morning and night)
• supervise children in the use of this product
• for athlete's foot, pay special attention to spaces between the toes, wear well-fitting, ventilated shoes and change 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, ask a doctor
• this product is not effective on the scalp or nails

Other information

• To open: unscrew cap, use the pointed end of cap to puncture seal.
• store between 20° - 25°C (68° - 77°F)
• see carton or tube crimp for lot number and expiration date

Inactive ingredients

benzyl alcohol (1%), cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sorbitan monostearate

Questions?

Call 1-866-923-4914

SPL UNCLASSIFIED SECTION

Manufactured by
Taro Pharmaceuticals Inc.
Brampton, Ontario, Canada L6T 1C1

Distributed by
Kaiser Foundation Hospitals
Livermore, CA 94551-9756

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

KAISER PERMANENTE®

Clotrimazole Cream USP, 1%

ANTIFUNGAL CREAM
CURES MOST ATHLETE'S FOOT

Compare to the active ingredient in Lotrimin ® AF*

NET WT 1 OZ (28.4 g)

INGREDIENTS AND APPEARANCE

CLOTRIMAZOLE  ATHLETES FOOT
clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0179-8014
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
BENZYL ALCOHOL (UNII: LKG8494WBH)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL ESTERS WAX (UNII: D072FFP9GU)
OCTYLDODECANOL (UNII: 461N1O614Y)
POLYSORBATE 60 (UNII: CAL22UVI4M)
WATER (UNII: 059QF0KO0R)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0179-8014-30	1 in 1 CARTON	08/31/1993	09/30/2020
1		28.4 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	08/31/1993	09/30/2020

Labeler - Kaiser Foundation Hospitals (053052619)

Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)

Establishment
Name	Address	ID/FEI	Business Operations
Taro Pharmaceuticals Inc.		206263295	manufacture(0179-8014)