Azolen Liquid
FDA Label NDC 58980-819

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Stratus Pharmaceuticals Inc for the product Azolen (NDC 58980-819). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Distributed by:
Stratus Pharmaceuticals Inc.
Miami, FL 33186

Active Ingredient

Miconazole Nitrate 2%

Purpose

Topical Antifungal

Uses

  • For the treatment of most:
    • athlete's foot
    • jock itch
    • ringworm
    • Relieves:
      • itching
      • scaling
      • cracking
      • burning
      • redness
      • discomfort

Warnings

for external use only

Do Not Use

  • on children under 2 years of age unless directed by a doctor
  • for diaper rash

When Using This Product

  • avoid contact with eyes

Stop Use And Ask A Doctor If

  • irritation occurs
  • there is no improvement within 2 weeks (for jock itch)
  • there is no improvement within 4 weeks (for athlete's foot and ringworm)

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center immediately

Directions

  • Wash the affected area well with AZOLEN Anti-Fungal Wash and let product sit 1-2 minutes before rinsing
  • Dry the affected area thoroughly
  • Apply the product over the affected area twice daily (morning and night) or as directed by a doctor
  • Supervise children in the use of this product
  • For athlete's foot: Pay special attention to spaces between 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, consult a doctor
  • This product is not effective on scalp or nails

Other Information

  • Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F) [See USP Controlled Room Temperature]

Inactive Ingredients

Lauramidopropyl Betaine, Laureth-7, Panthenol, Phospholipid EFA, Purified Water, Sodium Chloride, Sodium C14-16 Olefin Sulfonate, Tea Tree Oil.

Questions Or Comments?

Call us at 1-800-442-7882

Principal Display Panel - 170 G Bottle Box

NDC 58980-819-60

AZOLEN™
ANTI-FUNGAL WASH

(MICONAZOLE NITRATE 2%)

NOW TREAT
JOCK ITCH IN
THE SHOWER

SOOTHES AND
CONTROLS MOST:*
JOCK ITCH
ATHLETE'S FOOT
RINGWORM

STRATUS
PHARMACEUTICALS INC

Net Wt 6 oz (170 g)

Principal Display Panel (170 g Bottle Box)

Principal Display Panel (170 g Bottle Box)

* Please review the disclaimer below.