RxNorm Names

Review RxNorm Normal Forms

AZOLEN (miconazole nitrate) tincture
[Stratus Pharmaceuticals, Inc.]

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=9c2574f3-3be4-405a-9c87-943dc6ef8777

Category	DEA Schedule	Marketing Status
HUMAN OTC DRUG LABEL		OTC monograph not 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

Topical Antifungal

Uses

Cures most athlete's foot (tinea pedis) and ringworm (tinea corporis)
For effective relief of itchy, scaly skin between the toes.

WARNINGS

For external use only.

Do not use on children under 2 years of age except under supervision of doctor.

Avoid contact with eyes.

If irritation occurs or if there is no improvement within four weeks, discontinue use and consult a doctor.

Keep out of the reach of children. If swallowed, get medical help or contact poison control center immediately.

Directions

Clean and dry the affected area.
Cover the affected area with a thin layer twice a day (a.m. and p.m.) on skin, under nails and surrounding cuticle areas.
Supervise children in the use of this product.
For athlete's foot and ringworm use daily for four (4) weeks.
This product is not effective on scalp or nails.

Other Information

Store at 25°C (77°F); excursions permitted to 15°C - 30°C (59° - 86°F). [See USP Controlled Room Temperature]. Protect from freezing. If freezing occurs, warm to room temperature.

Inactive Ingredients

Benzyl Alcohol, Glacial Acetic Acid, Isopropyl Alcohol, Laureth-4, Purified Water and Sodium Hydroxide Solution.

For more information, see enclosed package insert.

Questions?

1-800-442-7882

Distributed by:
STRATUS PHARMACEUTICALS INC
12379 SW 130th Street
Miami, Florida 33186

PRINCIPAL DISPLAY PANEL - 29.57 mL Bottle Carton

NDC 58980-818-10

AZOLEN™
TINCTURE

(MICONAZOLE NITRATE USP, 2%)

TOPICAL ANTIFUNGAL

Distributed by:
STRATUS

NET VOL.: 1.0 FL OZ (29.57 mL)

Principal Display Panel - 29.57 mL Bottle Carton

AZOLEN
miconazole nitrate tincture

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58980-818
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 mL

Inactive Ingredients
Ingredient Name	Strength
Water
Benzyl Alcohol
Acetic Acid
Isopropyl Alcohol
Laureth-4
Sodium Hydroxide

Packaging
#	Item Code	Package Description
1	NDC:58980-818-10	1 in 1 BOX
1		29.57 mL in 1 BOTTLE, WITH APPLICATOR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part333C	12/01/2011

Labeler - Stratus Pharmaceuticals, Inc. (789001641)

Establishment
Name	Address	ID/FEI	Business Operations
Sonar Products Inc		104283945	MANUFACTURE(58980-818)

Revised: 02/2013

Document Id: 98954136-ca0b-43cd-ac80-f230097a4767

Set id: 9c2574f3-3be4-405a-9c87-943dc6ef8777

Version: 2

Effective Time: 20130220

Stratus Pharmaceuticals, Inc.

Daily Med

Current Medication Information

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