RxNorm Names

Review RxNorm Normal Forms

LOTRIMIN ANTIFUNGAL (miconazole nitrate) aerosol, powder
[MSD Consumer care, Inc.]

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=3650ee3d-b285-46b9-a80b-e868f22053aa

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

Miconazole nitrate 2%

Purpose

Antifungal

Uses

proven clinically effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis)
for effective relief of itching, cracking, burning, scaling and discomfort

Warnings

For external use only

Flammable: Do not use while smoking or near heat or flame

When using this product

avoid contact with the eyes
use only as directed. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal
contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F.

Stop use and ask a doctor if

irritation occurs
there is no improvement within 4 weeks (for athlete's foot and ringworm) or 2 weeks (for jock itch)

Do not use on children under 2 years of age except under the advice and supervision of 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
shake can well and spray 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 shoes and 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
in case of clogging, clean nozzle with a pin

Other information

store between 20° to 25°C (68° to 77°F)

Inactive ingredients

alcohol denat. (8% v/v), isobutane, stearalkonium hectorite, talc

Questions?

1-866-360-3266

Distributed by MSD Consumer Care, Inc., PO Box 377, Memphis, TN 38151 USA, a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ USA.

PRINCIPAL DISPLAY PANEL - 133 g Can Label

Powder Spray
goes on dry

NDC 11523-0544-2

LOTRIMIN® AF
ANTIFUNGAL
miconazole nitrate

Clinically Proven To Cure
Most Athlete's Foot

➤: Relieves Itching,
Burning, Cracking
& Scaling

NET WT 133g (4.6 OZ)

Principal Display Panel - 133 g Can Label

LOTRIMIN ANTIFUNGAL
miconazole nitrate aerosol, powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11523-0544
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Miconazole nitrate (Miconazole)	Miconazole nitrate	20 mg in 1 g

Inactive Ingredients
Ingredient Name	Strength
isobutane
talc

Product Characteristics
Color	WHITE (White to off-white)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description
1	NDC:11523-0544-2	133 g in 1 CAN

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333C	09/01/1993

Labeler - MSD Consumer care, Inc. (968091715)

Revised: 04/2012

Document Id: c75a5b1d-f274-469b-a880-f6586d3dd6e6

Set id: 3650ee3d-b285-46b9-a80b-e868f22053aa

Version: 1

Effective Time: 20120423

MSD Consumer care, Inc.

Daily Med

Current Medication Information

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