Drugplain

Anti-Fungal .02 g/g

Miconazole Nitrate · CREAM · Universal Distribution Center LLC

3 Recalls on Record
Plain English

Anti-Fungal is a cream containing miconazole nitrate at .02 g/g, taken topical. Manufactured by Universal Distribution Center LLC.

Key Facts

Brand Name
Anti-Fungal
Generic Name
Miconazole Nitrate
NDC Code (Product)
52000-021
Manufacturer
Universal Distribution Center LLC
Strength
.02 g/g
Dosage Form
CREAM
Route
TOPICAL
Marketing Status
Application #
M005
Marketing Start
04/15/2015

Recall History

3 Recalls on Record
Class II06/23/2022

Family Dollar Stores, Llc.

CGMP Deviations: product held outside appropriate storage temperature conditions.

OngoingVoluntary: Firm initiated
Class II04/19/2017

Gentell, Inc

GMP Deviations; product may not meet cGMP requirements

TerminatedVoluntary: Firm initiated
Class II06/23/2022

Family Dollar Stores, Llc.

CGMP Deviations: product held outside appropriate storage temperature conditions.

OngoingVoluntary: Firm initiated

Side Effects Reported to FDA

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

drug ineffective1,484 reports
nausea836 reports
pain816 reports
macular degeneration803 reports
off label use788 reports
headache748 reports
dyspnoea740 reports
fatigue656 reports
diarrhoea625 reports
pyrexia549 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 used for?

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

Is Anti-Fungal a controlled substance?

Anti-Fungal is not classified as a controlled substance by the DEA.

What is the generic name for Anti-Fungal?

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

What is the NDC code for Anti-Fungal .02 g/g?

The NDC (National Drug Code) for Anti-Fungal .02 g/g is 52000-021, listed by Universal Distribution Center LLC.