Drugplain

ANTIFUNGAL 2 g/100g

MICONAZOLE · POWDER · VIVE HEALTH LLC

10 Recalls on Record
Plain English

ANTIFUNGAL is a powder containing miconazole at 2 g/100g, taken topical. Manufactured by VIVE HEALTH LLC.

Key Facts

Brand Name
ANTIFUNGAL
Generic Name
MICONAZOLE
NDC Code (Product)
84722-3057
Manufacturer
VIVE HEALTH LLC
Strength
2 g/100g
Dosage Form
POWDER
Route
TOPICAL
Marketing Status
Application #
M005
Drug Class
Azole Antifungal [EPC]
Marketing Start
03/21/2025

Recall History

10 Recalls on Record
Class II11/17/2020

Taro Pharmaceuticals U.S.A., Inc.

Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.

TerminatedVoluntary: Firm initiated
Class II11/17/2020

Taro Pharmaceuticals U.S.A., Inc.

Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.

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 II11/17/2020

Taro Pharmaceuticals U.S.A., Inc.

Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.

TerminatedVoluntary: Firm initiated
Class III02/19/2013

Novartis Consumer Health

Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.

TerminatedVoluntary: Firm initiated
Class II11/17/2020

Taro Pharmaceuticals U.S.A., Inc.

Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.

TerminatedVoluntary: Firm initiated
Class II11/17/2020

Taro Pharmaceuticals U.S.A., Inc.

Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.

TerminatedVoluntary: Firm initiated
Class II03/03/2014

Terra-Medica Inc.

Penicillin Cross Contamination

TerminatedVoluntary: Firm initiated
Class III02/19/2013

Novartis Consumer Health

Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.

TerminatedVoluntary: Firm initiated
Class III02/19/2013

Novartis Consumer Health

Labeling: Incorrect or Missing Lot and/or Expiration date; The Lot and/or Expiration date on the tube may not be legible in this lot.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

drug ineffective3,350 reports
off label use2,300 reports
nausea1,978 reports
pain1,924 reports
fatigue1,809 reports
dyspnoea1,730 reports
headache1,721 reports
diarrhoea1,685 reports
rash1,523 reports
pruritus1,511 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses For the treatment of athlete´s foot.

Dosage & Administration

Directions Wash the affected area and dry thoroughly. Apply a thin layer of 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 the toes; wear well fitting, ventilated shoes, and change shoes and socks at least once daily. Use daily for 4 weeks. If condition persists, consults a physician. 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 use and ask a doctor if irritation occurs or if there is no improvement within 4 weeks. Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Frequently Asked Questions

What is ANTIFUNGAL used for?

ANTIFUNGAL contains MICONAZOLE. It is a powder taken topical. Consult your doctor for specific uses.

Is ANTIFUNGAL a controlled substance?

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

What is the generic name for ANTIFUNGAL?

The generic name for ANTIFUNGAL is MICONAZOLE. There are 11 other brand versions of MICONAZOLE.

What is the NDC code for ANTIFUNGAL 2 g/100g?

The NDC (National Drug Code) for ANTIFUNGAL 2 g/100g is 84722-3057, listed by VIVE HEALTH LLC.