Drugplain

Clotrimazole 10 mg/1

clotrimazole · LOZENGE · Padagis US LLC

10 Recalls on Record
Plain English

Clotrimazole lozenges are an antifungal medication used to treat fungal infections of the mouth and throat. You dissolve the lozenge in your mouth to allow the medication to coat the affected areas.

Key Facts

Brand Name
Clotrimazole
Generic Name
clotrimazole
NDC Code (Product)
0574-0107
Manufacturer
Padagis US LLC
Strength
10 mg/1
Dosage Form
LOZENGE
Route
ORAL
Marketing Status
Application #
ANDA076763
Drug Class
Azole Antifungal [EPC]
Marketing Start
12/01/2005

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 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 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 II05/17/2016

Well Care Compounding Pharmacy

Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and sterility.

TerminatedVoluntary: Firm initiated
Class II06/02/2015

The Compounding Pharmacy of America

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

TerminatedVoluntary: Firm initiated
Class II01/27/2017

Cherry Hill Sales Co.

CGMP Deviations

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 III08/07/2019

Glenmark Pharmaceuticals Inc., USA

Temperature Abuse: Complaints received of liquidy texture.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

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

drug ineffective1,377 reports
nausea835 reports
macular degeneration804 reports
pain798 reports
off label use745 reports
headache737 reports
dyspnoea718 reports
fatigue674 reports
diarrhoea608 reports
pyrexia539 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses Cures athlete’s foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis). Relieves the itching, irritation, redness, scaling and discomfort which can accompany these conditions.

Dosage & Administration

Directions • Wash the affected area and dry thoroughly. ● Apply a thin layer of this 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 the 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 persists longer, consult a doctor. ● This product is not effective on the scalp or nails.

Warnings

Warnings For External use only.

Frequently Asked Questions

What is Clotrimazole used for?

Clotrimazole lozenges are an antifungal medication used to treat fungal infections of the mouth and throat. You dissolve the lozenge in your mouth to allow the medication to coat the affected areas.

Is Clotrimazole a controlled substance?

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

What is the generic name for Clotrimazole?

The generic name for Clotrimazole is clotrimazole. There are 9 other brand versions of clotrimazole.

What is the NDC code for Clotrimazole 10 mg/1?

The NDC (National Drug Code) for Clotrimazole 10 mg/1 is 0574-0107, listed by Padagis US LLC.