Drugplain

AZOLEN 2 mg/g

MICONAZOLE NITRATE · LIQUID · STRATUS PHARMACEUTICALS INC

No Recall History
Plain English

AZOLEN is a liquid containing miconazole nitrate at 2 mg/g, taken topical. Manufactured by STRATUS PHARMACEUTICALS INC.

Key Facts

Brand Name
AZOLEN
Generic Name
MICONAZOLE NITRATE
NDC Code (Product)
58980-819
Manufacturer
STRATUS PHARMACEUTICALS INC
Strength
2 mg/g
Dosage Form
LIQUID
Route
TOPICAL
Marketing Status
Application #
M005
Marketing Start
09/14/2023

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

vulvovaginal burning sensation174 reports
drug ineffective130 reports
off label use62 reports
drug interaction59 reports
vulvovaginal pain59 reports
condition aggravated58 reports
vulvovaginal pruritus53 reports
international normalised ratio increased41 reports
constipation39 reports
pain39 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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

Dosage & Administration

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

Warnings

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

Frequently Asked Questions

What is AZOLEN used for?

AZOLEN contains MICONAZOLE NITRATE. It is a liquid taken topical. Consult your doctor for specific uses.

Is AZOLEN a controlled substance?

AZOLEN is not classified as a controlled substance by the DEA.

What is the generic name for AZOLEN?

The generic name for AZOLEN is MICONAZOLE NITRATE. There are 12 other brand versions of MICONAZOLE NITRATE.

What is the NDC code for AZOLEN 2 mg/g?

The NDC (National Drug Code) for AZOLEN 2 mg/g is 58980-819, listed by STRATUS PHARMACEUTICALS INC.