RxNorm Names

Review RxNorm Normal Forms

TOPCARE ANTIFUNGAL (clotrimazole) cream
[Topco Associates LLC]

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=6757eb2a-73e0-4bd0-a332-5713fdf3445d

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 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?

1-888-423-0139
topcare@topco.com

DISTRIBUTED BY
TOPCO ASSOCIATES LLC
7711 GROSS POINT ROAD
SKOKIE, IL 60077

PRINCIPAL DISPLAY PANEL - 14.2 g Tube Carton

TopCare®

CURES MOST ATHLETE'S FOOT

Antifungal Cream

CLOTRIMAZOLE CREAM USP, 1%

QUALITY
GUARANTEED

COMPARE TO
LOTRIMIN® AF
active ingredient*

NET WT 0.5 OZ (14.2 g)

Principal Display Panel - 14.2 g Tube Carton

TOPCARE ANTIFUNGAL
clotrimazole cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-495
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

Packaging
#	Item Code	Package Description
1	NDC:36800-495-69	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	08/31/1993

Labeler - Topco Associates LLC (006935977)

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

Establishment
Name	Address	ID/FEI	Business Operations
Taro Pharmaceuticals Inc.		206263295	MANUFACTURE(36800-495)

Revised: 01/2013

Document Id: 5ea9c208-ef94-4854-89d9-a4b72acf51ca

Set id: 6757eb2a-73e0-4bd0-a332-5713fdf3445d

Version: 1

Effective Time: 20130108

Topco Associates LLC

Daily Med

Current Medication Information

Options

Additional Resources