Drugplain

MICONAZOLE Nitrate 2% Cream ANTIFUNGAL 2 g/100g

MICONAZOLE NITRATE · CREAM · Rugby

No Recall History
Plain English

MICONAZOLE Nitrate 2% Cream ANTIFUNGAL is a cream containing miconazole nitrate at 2 g/100g, taken topical. Manufactured by Rugby.

Key Facts

Brand Name
MICONAZOLE Nitrate 2% Cream ANTIFUNGAL
Generic Name
MICONAZOLE NITRATE
NDC Code (Product)
0536-1375
Manufacturer
Rugby
Strength
2 g/100g
Dosage Form
CREAM
Route
TOPICAL
Marketing Status
Application #
M005
Marketing Start
02/07/2023

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 ineffective134 reports
off label use59 reports
vulvovaginal pain59 reports
condition aggravated58 reports
drug interaction58 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 • proven clinically effective in the treatment of most athlete's foot (tinea pedis), jock itch (tinea crurus), and ringworm (tinea capitis) • relieves itching, scaling, cracking, burning and discomfort associated with these conditions.

Dosage & Administration

Directions Clean the affected area and dry thoroughly • Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a healthcare professional • Supervise children in the use of this product. For athlete's foot: • Use daily for 4 weeks. If condition persists, consult a healthcare professional. • Pay special attention to the spaces between the toes • Wear well fitting, ventilated shoes • Change socks atleast once daily. For ringworm: Use daily for 4 weeks. If condition persists, consult a healthcare professional. For jock itch: Use daily for 2 weeks. If condition persists longer, consult a healthcare professional. This product is not effective on the scalp or nails.

Warnings

Warnings For external use only. Do not use if the safety-sealed tube is punctured or damaged. Do not use on children under 2 years of age unless directed by a healthcare professional. When using this product avoid contact with the eyes. Stop use and ask a healthcare professional if • irritation occurs or if there is no improvement within 4 weeks (for athlete's foot and ringworm) • Irritation occurs, or if there is no improvement within 2 weeks (for jock itch).

Frequently Asked Questions

What is MICONAZOLE Nitrate 2% Cream ANTIFUNGAL used for?

MICONAZOLE Nitrate 2% Cream ANTIFUNGAL contains MICONAZOLE NITRATE. It is a cream taken topical. Consult your doctor for specific uses.

Is MICONAZOLE Nitrate 2% Cream ANTIFUNGAL a controlled substance?

MICONAZOLE Nitrate 2% Cream ANTIFUNGAL is not classified as a controlled substance by the DEA.

What is the generic name for MICONAZOLE Nitrate 2% Cream ANTIFUNGAL?

The generic name for MICONAZOLE Nitrate 2% Cream ANTIFUNGAL is MICONAZOLE NITRATE. There are 12 other brand versions of MICONAZOLE NITRATE.

What is the NDC code for MICONAZOLE Nitrate 2% Cream ANTIFUNGAL 2 g/100g?

The NDC (National Drug Code) for MICONAZOLE Nitrate 2% Cream ANTIFUNGAL 2 g/100g is 0536-1375, listed by Rugby.

Product NDC

0536-1375

Package NDC

0536-1375-75

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)