Azolen™

Drug Facts

Composition & Product

Active Ingredients

Miconazole (2 mg)

Inactive Ingredients

Sodium Chloride Panthenol Tea Tree Oil Laureth-7 Sodium C14-16 Olefin Sulfonate Lauramidopropyl Betaine Linoleamidopropyl Propylene Glycol-dimonium Chloride Phosphate Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2023-09-14

Medication Information

Purpose

Topical Antifungal

Description

Drug Facts

Uses

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

Section 42229-5

Drug Facts

Section 50565-1

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

Warnings

for external use only

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

Do Not Use

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

Active Ingredient

Miconazole Nitrate 2%

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

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)

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)

Structured Label Content

Uses

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Purpose

Topical Antifungal

Warnings

for external use only

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

Do Not Use (Do not use)

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

Active Ingredient

Miconazole Nitrate 2%

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? (Questions or Comments?)

Call us at 1-800-442-7882

When Using This Product (When using this product)

avoid contact with eyes

Stop Use and Ask A Doctor If (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)

Principal Display Panel 170 G Bottle Box (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)

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Uses": "For the treatment of most: athlete's foot jock itch ringworm Relieves: itching scaling cracking burning redness discomfort", "42229-5": "Drug Facts", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center immediately", "Purpose": "Topical Antifungal", "Warnings": "for external use only", "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", "Do not use": "on children under 2 years of age unless directed by a doctor for diaper rash", "Active Ingredient": "Miconazole Nitrate 2%", "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", "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)", "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)"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information