RxNorm Names

Review RxNorm Normal Forms

RITE AID ANTIFUNGAL RINGWORM (clotrimazole) cream
[Rite Aid Corporation]

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=1ad7cd82-d01b-403e-a2c1-2302db2a78df

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 ringworm
relieves itching, redness, irritation and discomfort which accompany this condition

Warnings

For external use only

When using this product avoid contact with eyes

Stop use and ask a doctor if

irritation occurs
there is no improvement within 4 weeks

Do not use on children under 2 years of age unless directed by a doctor.

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
use daily for 4 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

DISTRIBUTED BY:
RITE AID, 30 HUNTER LANE
CAMP HILL, PA 17011

PRINCIPAL DISPLAY PANEL - 14.2 g Tube Carton

RITE
AID®
PHARMACY

antifungal ringworm cream

clotrimazole cream USP, 1%

cures most ringworm
relieves itching, redness, & irritation
for adults & children 2 years and older

NET WT 0.5 OZ (14.2 g)

Principal Display Panel - 14.2 g Tube Carton

RITE AID ANTIFUNGAL RINGWORM
clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11822-1110
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Clotrimazole (Clotrimazole)	Clotrimazole	1 g in 100 g

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

Packaging
#	Item Code	Package Description
1	NDC:11822-1110-1	1 in 1 CARTON
1		14.2 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333C	06/01/1995

Labeler - Rite Aid Corporation (014578892)

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

Establishment
Name	Address	ID/FEI	Business Operations
Taro Pharmaceuticals Inc.		206263295	MANUFACTURE(11822-1110)

Revised: 01/2013

Document Id: 3b874e01-dbfb-460d-bcfb-52be8e4819dd

Set id: 1ad7cd82-d01b-403e-a2c1-2302db2a78df

Version: 1

Effective Time: 20130129

Rite Aid Corporation

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