Clotrimazole Cream, USP

Drug Labeling and Warnings

Drug Details [pdf]

JOCK ITCH- clotrimazole cream 
Walgreen Company

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.

----------

Clotrimazole Cream, USP

Drug Facts

Active ingredient

Clotrimazole, USP 1%

Purpose

Antifungal

Uses

cures most jock itch relieves itching, burning, scaling, discomfort, and chafing associated with jock itch

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 the eyes

Stop use and ask a doctor if    irritation occurs   there is no improvement within 2 weeks

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

Directions

wash the affected area and dry thoroughly
apply a thin layer of the 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 condition lasts longer, ask a doctor
this product is not effective on the scalp or nails

Other information

Store between 2°-30°C (36°-86°F). 
Before using any medication, read all label directions   Keep carton, it contains important information

Inactive ingredients

benzyl alcohol, cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sodium phosphate monobasic, sorbitan monostearate

Questions?

1-800-432-8534 between 9 am and 4 pm EST, Monday – Friday.

Principal Display Panel

Walgreens
NDC: 0363-3510-34 

Jock Itch Cream
Clotrimazole Cream, USP 1%
Antifungal Cream 

• Proven clinically effective in the treatment of most jock itch 
• Relieves itching, burning, scaling & chafing 

Compare to Lotrimin® AF active ingredient# 

Cures most jock itch.  

NET WT 0.5 OZ (14 g)

JOCK ITCH 
clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-3510
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)	CLOTRIMAZOLE	1 g  in 100 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)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-3510-34	1 in 1 CARTON	06/15/2014	11/01/2016
1		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	06/15/2014	11/01/2016

Labeler - Walgreen Company (008965063)

Registrant - Teva Pharmaceuticals USA, Inc. (001627975)

Revised: 5/2019

Document Id: 57630df3-cf7c-4146-9ee9-1e93ce2a7cbc

34390-5

Set id: 29fbce15-64fa-4d9e-8c1b-4d3ddb329e43

Version: 7

Effective Time: 20190529