AZOLEN- miconazole nitrate tincture

Azolen by

Drug Labeling and Warnings

Azolen by is a Otc medication manufactured, distributed, or labeled by Stratus Pharmaceuticals, Inc., TARMAC PRODUCTS INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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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.

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For more information, see enclosed package insert.

Questions?

1-800-442-7882

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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)

INGREDIENTS AND APPEARANCE

AZOLEN 
miconazole nitrate tincture

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58980-818
Route of Administration	TOPICAL

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	09/15/2017
1		29.57 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	09/15/2017

Labeler - Stratus Pharmaceuticals, Inc. (789001641)

Establishment
Name	Address	ID/FEI	Business Operations
TARMAC PRODUCTS INC		059890491	MANUFACTURE(58980-818) , LABEL(58980-818) , PACK(58980-818)