RxNorm Names

Review RxNorm Normal Forms

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

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=cebd222c-074f-443c-bd37-612114b27bbd

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

Cures most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis)
relieves itching, cracking, burning and scaling

Warnings

For external use only

Avoid contact with the eyes

Stop use and ask a doctor if irritation occurs or if 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 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
sprinkle 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

Other information

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

Inactive ingredients

benzethonium chloride, corn starch, kaolin, sodium bicarbonate, starch/acrylates/acrylamide copolymer, zinc oxide

© Copyright & 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 - 90g Can Label

NDC 11523-0919-1

LOTRIMIN®AF
ANTIFUNGAL
miconazole nitrate

Cures Most
Athlete's Foot

POWDER

➤: Absorbs Moisture
➤: Relieves Itching,
Burning & Scaling

NET WT 90g (3 OZ)

37871-00

LOTRIMIN ANTIFUNGAL
miconazole nitrate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11523-0919
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
benzethonium chloride
starch, corn
kaolin
sodium bicarbonate
zinc oxide

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

Packaging
#	Item Code	Package Description
1	NDC:11523-0919-1	90 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: 02/2013

Document Id: 67d8c8b1-4bf4-424e-b932-027167f746d7

Set id: cebd222c-074f-443c-bd37-612114b27bbd

Version: 2

Effective Time: 20130206

MSD Consumer care, Inc.

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