CLOTRIMAZOLE ATHLETES FOOT- clotrimazole cream
Kaiser Foundation Hospitals

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Clotrimazole USP, 1%

Athlete's Foot

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

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)

Principal Display Panel - 28.4 g Tube Carton

CLOTRIMAZOLE ATHLETES FOOT
clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0179-8014
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333C	08/31/1993	09/30/2020

Labeler - Kaiser Foundation Hospitals (053052619)

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

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

Revised: 11/2018

Document Id: 7ad27cc5-ac46-1c22-e053-2991aa0a663b

Set id: 1aca67ce-73e5-4ed5-89ff-55f3294d5e5e

Version: 3

Effective Time: 20181116

Kaiser Foundation Hospitals

Clotrimazole USP, 1% Athlete's Foot