AZOLEN- miconazole nitrate tincture 
Stratus Pharmaceuticals, Inc.

Disclaimer: 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 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:58980-818
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Miconazole Nitrate (Miconazole) Miconazole Nitrate0.5914 mL  in 29.57 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Benzyl Alcohol 
Acetic Acid 
Isopropyl Alcohol 
Laureth-4 
Sodium Hydroxide 
Packaging
#Item CodePackage Description
1NDC:58980-818-101 in 1 BOX
129.57 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart333C12/01/2011
Labeler - Stratus Pharmaceuticals, Inc. (789001641)
Establishment
NameAddressID/FEIBusiness Operations
Sonar Products Inc104283945MANUFACTURE(58980-818)

Revised: 10/2011
Document Id: ea449c55-095e-43c8-96a3-8efa4acb66e0
Set id: 9c2574f3-3be4-405a-9c87-943dc6ef8777
Version: 1
Effective Time: 20111014
 
Stratus Pharmaceuticals, Inc.