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.

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AZOLEN™
TINCTURE

Drug Facts

Active Ingredient

Miconazole Nitrate 2%

Purpose

Topical Antifungal

Uses

WARNINGS

  • 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

Other Information

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 (UNII: VW4H1CYW1K) (Miconazole - UNII:7NNO0D7S5M) Miconazole Nitrate 20 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
Water (UNII: 059QF0KO0R)  
Benzyl Alcohol (UNII: LKG8494WBH)  
Acetic Acid (UNII: Q40Q9N063P)  
Isopropyl Alcohol (UNII: ND2M416302)  
Laureth-4 (UNII: 6HQ855798J)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
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: 2/2013
Document Id: 98954136-ca0b-43cd-ac80-f230097a4767
Set id: 9c2574f3-3be4-405a-9c87-943dc6ef8777
Version: 2
Effective Time: 20130220
 
Stratus Pharmaceuticals, Inc.