FDA Label for Azolen
View Indications, Usage & Precautions
Azolen Product Label
The following document was submitted to the FDA by the labeler of this product Stratus Pharmaceuticals Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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)
* Please review the disclaimer below.