Clotrimazole Topical Solution USP, 1% 10 mg/mL
Clotrimazole Topical Solution USP, 1% · SOLUTION · Akron Pharma Inc.
Clotrimazole Topical Solution USP, 1% is a solution containing clotrimazole topical solution usp, 1% at 10 mg/mL, taken topical. Manufactured by Akron Pharma Inc..
Key Facts
- Brand Name
- Clotrimazole Topical Solution USP, 1%
- Generic Name
- Clotrimazole Topical Solution USP, 1%
- NDC Code (Product)
71399-0666- Manufacturer
- Akron Pharma Inc.
- Strength
- 10 mg/mL
- Dosage Form
- SOLUTION
- Route
- TOPICAL
- Marketing Status
- Application #
- ANDA216569
- Drug Class
- Azole Antifungal [EPC]
- Marketing Start
- 10/16/2023
Recall History
No Recall HistoryFull Prescribing Information
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 USP, 1% contains Clotrimazole Topical Solution USP, 1%. It is a solution taken topical. Consult your doctor for specific uses.
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 71399-0666, listed by Akron Pharma Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)