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

Warnings

for external use only

Uses

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

Purpose

Topical Antifungal

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.

Description

Drug Facts

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

Do Not Use

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

Active Ingredient

Miconazole Nitrate 2%

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

Warnings

for external use only

Uses

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

Purpose

Topical Antifungal

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.

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

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%

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