Benzamycin
Benzamycin is an FDA drug label for the active ingredient ERYTHROMYCIN AND BENZOYL PEROXIDE manufactured by Bausch Health US, LLC. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20201130.
- Generic name
- ERYTHROMYCIN AND BENZOYL PEROXIDE
- Manufacturer
- Bausch Health US, LLC
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- N/A
- Dosage form
- N/A
- NDC
- 0187-5205
- Application
- NDA050557
- Label effective
- 20201130
Indications & Usage
INDICATIONS AND USAGE Benzamycin Topical Gel is indicated for the topical treatment of acne vulgaris.
Dosage & Administration
DOSAGE AND ADMINISTRATION Benzamycin Topical Gel should be applied twice daily, morning and evening, or as directed by a physician, to affected areas after the skin is thoroughly washed, rinsed with warm water and gently patted dry.
Contraindications
CONTRAINDICATIONS Benzamycin Topical Gel is contraindicated in those individuals who have shown hypersensitivity to any of its components.
Warnings
WARNINGS Pseudomembranous colitis has been reported with nearly all antibacterial agents, including erythromycin, and may range in severity from mild to life-threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents. Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is one primary cause of “antibiotic-associated colitis”. After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation and treatment with an antibacterial drug clinically effective against C. difficile colitis.
Adverse Reactions
ADVERSE REACTIONS In controlled clinical trials, the incidence of adverse reactions associated with the use of Benzamycin Topical Gel was approximately 3%. These were dryness and urticarial reaction. The following additional local adverse reactions have been reported occasionally: irritation of the skin including peeling, itching, burning sensation, erythema, inflammation of the face, eyes and nose, and irritation of the eyes. Skin discoloration, oiliness and tenderness of the skin have also been reported. To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.