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Anti-fungal Powder Miconazole Nitrate 20 mg/g

Miconazole Nitrate · POWDER · Premier Brands of America Inc.

No Recall History
Plain English

Anti-fungal Powder Miconazole Nitrate is a powder containing miconazole nitrate at 20 mg/g, taken topical. Manufactured by Premier Brands of America Inc..

Key Facts

Brand Name
Anti-fungal Powder Miconazole Nitrate
Generic Name
Miconazole Nitrate
NDC Code (Product)
56104-500
Manufacturer
Premier Brands of America Inc.
Strength
20 mg/g
Dosage Form
POWDER
Route
TOPICAL
Marketing Status
Application #
M005
Marketing Start
09/12/2023

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 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 for the cure of most athlete's foot, jock itch and ringworm

Dosage & Administration

Directions clean the affected area and dry thoroughly apply a thin layer of product over 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 the 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 conditions persist longer, consult a doctor this product is not effective on the scalp or nails

Warnings

Warnings For external use only. Do not use on children under 2 years of age unless directed by a doctor. When using this product avoid contact with the eyes Stop and ask a doctor if irritation occurs or there is no improvement within 4 weeks for athlete's foot and ringworm, or 2 weeks for jock itch. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Frequently Asked Questions

What is Anti-fungal Powder Miconazole Nitrate used for?

Anti-fungal Powder Miconazole Nitrate contains Miconazole Nitrate. It is a powder taken topical. Consult your doctor for specific uses.

Is Anti-fungal Powder Miconazole Nitrate a controlled substance?

Anti-fungal Powder Miconazole Nitrate is not classified as a controlled substance by the DEA.

What is the generic name for Anti-fungal Powder Miconazole Nitrate?

The generic name for Anti-fungal Powder Miconazole Nitrate is Miconazole Nitrate. There are 11 other brand versions of Miconazole Nitrate.

What is the NDC code for Anti-fungal Powder Miconazole Nitrate 20 mg/g?

The NDC (National Drug Code) for Anti-fungal Powder Miconazole Nitrate 20 mg/g is 56104-500, listed by Premier Brands of America Inc..