Drugplain

Miconazole Nitrate 20 mg/g

Miconazole Nitrate · CREAM · Sun Pharmaceutical Industries, Inc.

10 Recalls on Record
Plain English

Miconazole Nitrate is a cream containing miconazole nitrate at 20 mg/g, taken topical. Manufactured by Sun Pharmaceutical Industries, Inc..

Key Facts

Brand Name
Miconazole Nitrate
Generic Name
Miconazole Nitrate
NDC Code (Product)
51672-2001
Manufacturer
Sun Pharmaceutical Industries, Inc.
Strength
20 mg/g
Dosage Form
CREAM
Route
TOPICAL
Marketing Status
Application #
M005
Marketing Start
10/01/1991

Recall History

10 Recalls on Record
Class III10/18/2016

GSK Consumer Healthcare

Labeling Not Elsewhere Classified: front labels have the incorrect NDC or 0145-1506-01 instead of the correct NDC of 0145-1506-05 and some back labels have the incorrect indication stating "use for the cure of most jock itch" rather than "use for the cure of most athlete's foot".

TerminatedVoluntary: Firm initiated
Class II08/27/2025

DermaRite Industries, LLC

CGMP Deviation; manufactured at the same facility where other products and lots were found to be contaminated.

OngoingVoluntary: Firm initiated
Class I10/01/2021

Bayer Healthcare Pharmaceuticals Inc.

Chemical Contamination: presence of benzene

TerminatedVoluntary: Firm initiated
Class II10/01/2021

Bayer Healthcare Pharmaceuticals Inc.

cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.

TerminatedVoluntary: Firm initiated
Class I10/01/2021

Bayer Healthcare Pharmaceuticals Inc.

Chemical Contamination: presence of benzene

TerminatedVoluntary: Firm initiated
Class II10/01/2021

Bayer Healthcare Pharmaceuticals Inc.

cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.

TerminatedVoluntary: Firm initiated
Class II11/14/2014

Attix Pharmaceuticals

Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

TerminatedVoluntary: Firm initiated
Class II01/10/2024

MEDLINE INDUSTRIES, LP - Northfield

Labeling: Not Elsewhere Classified; Product labeling contains the claim of 'Paraben Free' while the product does in fact contain parabens as part of the formulation/ ingredient list.

OngoingVoluntary: Firm initiated
Class II01/27/2017

Cherry Hill Sales Co.

CGMP Deviations

TerminatedVoluntary: Firm initiated
Class II10/01/2021

Bayer Healthcare Pharmaceuticals Inc.

cGMP Deviations: manufactured at the same facility where other lots were found to be contaminated with benzene.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

vulvovaginal burning sensation174 reports
drug ineffective139 reports
condition aggravated60 reports
off label use60 reports
vulvovaginal pain59 reports
drug interaction58 reports
vulvovaginal pruritus53 reports
sepsis43 reports
constipation42 reports
international normalised ratio increased41 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses cures most athlete's foot (linea pedis), ringworm (linea corporis) and jock itch (linea cruris) relieves symptoms of athlete's foot, including itching, burning and cracking

Dosage & Administration

Directions wash affected area and dry thoroughly shake can well and spray a thin layer 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 use daily for 4 weeks for athlete's foot and ringworm; use daily for 2 weeks for jock itch; if conditions persists, consult a doctor this product is not effective on the scalp or nails if nozzle clogs, clean with a pin

Warnings

For external use only. Flammable: Do not use while smoking or near heat or flame. Do not puncture or incinerate. Contents under pressure. Do not store at temperature above 120ºF. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal. When using this product avoid contact with the eyes or mouth use only as directed Stop use and ask a doctor if irritation occurs no improvement within 4 weeks for athlete's foot and ringworm; 2 weeks for jock itch Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Do not use on children under 2 years of age unless directed by a doctor. Do not use on children under 2 years of age unless directed by a doctor.

Frequently Asked Questions

What is Miconazole Nitrate used for?

Miconazole Nitrate contains Miconazole Nitrate. It is a cream taken topical. Consult your doctor for specific uses.

Is Miconazole Nitrate a controlled substance?

Miconazole Nitrate is not classified as a controlled substance by the DEA.

What is the generic name for Miconazole Nitrate?

The generic name for Miconazole Nitrate is Miconazole Nitrate. There are 11 other brand versions of Miconazole Nitrate.

What is the NDC code for Miconazole Nitrate 20 mg/g?

The NDC (National Drug Code) for Miconazole Nitrate 20 mg/g is 51672-2001, listed by Sun Pharmaceutical Industries, Inc..