RxNorm Names

Review RxNorm Normal Forms

KROGER JOCK ITCH (clotrimazole) cream
[Kroger Company]

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=cc536b67-8b0b-4939-b0fb-9a9e4188c4e5

Category	DEA Schedule	Marketing Status
HUMAN OTC DRUG LABEL		OTC monograph final

NOTE: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.

Drug Label Sections

Description
Clinical Pharmacology
Indications & Usage
Contraindications
Warnings
Precautions
Adverse Reactions
Overdosage
Dosage & Administration
How Supplied
Patient Counseling Information
Supplemental Patient Material
Boxed Warning
Patient Package Insert
Highlights
Full Table of Contents
Medication Guide

Drug Facts

Active ingredient

Clotrimazole 1%

Purpose

Antifungal

Uses

cures most jock itch (tinea cruris)
for effective relief of
- itching
- scaling
- cracking
- burning
- redness
- soreness
- irritation
- discomfort

Warnings

For external use only

Ask a doctor before use

on children under 2 years of age

When using this product

avoid contact with eyes

Stop use and ask a doctor if

irritation occurs
there is no improvement within 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

This product is not effective on the scalp or nails.

For jock itch: use daily for 2 weeks.

clean 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

Other information

To open: unscrew cap, use the pointed end of cap to puncture seal.
store between 2° - 30°C (36° - 86°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?

1-800-632-6900

DISTRIBUTED BY
THE KROGER CO.
CINCINNATI, OHIO 45202

PRINCIPAL DISPLAY PANEL - 15 g Tube Carton

Kroger®
QUALITY GUARANTEED

Cures Most Jock Itch
JOCK ITCH CREAM

Clotrimazole Cream USP,1%
Antifungal Cream

NET WT
0.5OZ (15 g)

PRINCIPAL DISPLAY PANEL - 15 g Tube Carton

KROGER JOCK ITCH
clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:30142-510
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Clotrimazole (Clotrimazole)	Clotrimazole	10 mg in 1 g

Inactive Ingredients
Ingredient Name	Strength
benzyl alcohol
cetostearyl alcohol
cetyl esters wax
octyldodecanol
polysorbate 60
water
sorbitan monostearate

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description
1	NDC:30142-510-01	1 in 1 CARTON
1		15 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333C	08/31/1993

Labeler - Kroger Company (006999528)

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

Establishment
Name	Address	ID/FEI	Business Operations
Taro Pharmaceuticals Inc.		206263295	MANUFACTURE(30142-510)

Revised: 01/2013

Document Id: 2ec8f755-9215-40a1-9eaa-6b4b16f827b4

Set id: cc536b67-8b0b-4939-b0fb-9a9e4188c4e5

Version: 1

Effective Time: 20130131

Kroger Company

Daily Med

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