Drugplain

Clotrimazole Topical Solution USP, 1% 10 mg/mL

Clotrimazole Topical Solution USP, 1% · SOLUTION · Bryant Ranch Prepack

No Recall History
Plain English

Clotrimazole Topical Solution is an antifungal medication used to treat fungal infections of the skin and nails. It works by stopping the growth of fungi and is applied directly to the affected area.

Key Facts

Brand Name
Clotrimazole Topical Solution USP, 1%
Generic Name
Clotrimazole Topical Solution USP, 1%
NDC Code (Product)
72162-2178
Manufacturer
Bryant Ranch Prepack
Strength
10 mg/mL
Dosage Form
SOLUTION
Route
TOPICAL
Marketing Status
Application #
ANDA212281
Drug Class
Azole Antifungal [EPC]
Marketing Start
07/25/2019

Recall History

No Recall History

Side Effects Reported to FDA

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

off label use10 reports
accidental exposure to product3 reports
ear pain3 reports
incorrect route of drug administration3 reports
ocular hyperaemia3 reports
product administered at inappropriate site3 reports
wrong drug administered3 reports
burning sensation2 reports
ear discomfort2 reports
eye irritation2 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE Prescription Clotrimazole Topical Solution product is indicated for the topical treatment of candidiasis due to Candida albicans and tinea versicolor due to Malassezia furfur . This formulation is also available as a nonprescription product which is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes , Epidermophyton fluoccosum , and Microsporum canis .

Dosage & Administration

DOSAGE AND ADMINISTRATION Gently massage sufficient Clotrimazole Topical Solution, USP 1% into the affected and surrounding skin areas twice a day, in the morning and evening. Clinical improvement, with relief of pruritus, usually occurs within the first week of treatment with Clotrimazole Topical Solution, USP 1%. If the patient shows no clinical improvement after 4 weeks of treatment with Clotrimazole Topical Solution, USP 1% the diagnosis should be reviewed.

Warnings

WARNINGS Clotrimazole Topical Solution is not for ophthalmic use.

Contraindications

CONTRAINDICATIONS Topical antifungal agents are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Drug Interactions

Drug Interactions Synergism or antagonism between clotrimazole and nystatin, or amphotericin B, or flucytosine against strains of C. albicans has not been reported.

Adverse Reactions

ADVERSE REACTIONS The following adverse reactions have been reported in connection with the use of clotrimazole: erythema, stinging, blistering, peeling, edema, pruritius, urticaria, burning, and general irritation of the skin. To report SUSPECTED ADVERSE REACTIONS, contact ScieGen Pharmaceuticals, Inc. at 1-855-724-3436 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

Frequently Asked Questions

What is Clotrimazole Topical Solution USP, 1% used for?

Clotrimazole Topical Solution is an antifungal medication used to treat fungal infections of the skin and nails. It works by stopping the growth of fungi and is applied directly to the affected area.

Is Clotrimazole Topical Solution USP, 1% a controlled substance?

Clotrimazole Topical Solution USP, 1% is not classified as a controlled substance by the DEA.

What is the generic name for Clotrimazole Topical Solution USP, 1%?

The generic name for Clotrimazole Topical Solution USP, 1% is Clotrimazole Topical Solution USP, 1%. There are no other listed brand versions of Clotrimazole Topical Solution USP, 1%.

What is the NDC code for Clotrimazole Topical Solution USP, 1% 10 mg/mL?

The NDC (National Drug Code) for Clotrimazole Topical Solution USP, 1% 10 mg/mL is 72162-2178, listed by Bryant Ranch Prepack.

Product NDC

72162-2178

Package NDC

72162-2178-3

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)