Rosadan Cream Description

Rosadan® (metronidazole) Topical Cream contains metronidazole, USP, at a concentration of 7.5 mg per gram (0.75%) in an emollient cream consisting of emulsifying wax, sorbitol solution, glycerin, isopropyl palmitate, benzyl alcohol, lactic acid and/or sodium hydroxide to adjust pH, and purified water. Metronidazole is a member of the imidazole class of antibacterial agents and is classified therapeutically as an antiprotozoal and antibacterial agent. Chemically, metronidazole is 2-methyl-5-nitro-1H-imidazole-1-ethanol. The molecular formula is C6H9N3O3 and molecular weight is 171.16. Metronidazole is represented by the following structural formula:

Rosadan Cream - Clinical Pharmacology

The mechanisms by which metronidazole acts in the treatment of rosacea are unknown, but appear to include an anti-inflammatory effect.

Indications and Usage for Rosadan Cream

Rosadan® (metronidazole) Topical Cream is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.

Contraindications

Rosadan® (metronidazole) Topical Cream is contraindicated in individuals with a history of hypersensitivity to metronidazole, or other ingredients of the formulation.

Precautions

Adverse Reactions/Side Effects

In controlled clinical trials, the total incidence of adverse reactions associated with the use of topical metronidazole cream was approximately 10%. Skin discomfort (burning and stinging) was the most frequently reported event followed by erythema, skin irritation, pruritus and worsening of rosacea. All individual events occurred in less than 3% of patients. The following additional adverse experiences have been reported with the topical use of metronidazole: dryness, transient redness, metallic taste, tingling or numbness of extremities and nausea.

To report SUSPECTED ADVERSE REACTIONS, contact Medimetriks Pharmaceuticals, Inc. at 1-973-882-7512 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Rosadan Cream Dosage and Administration

Apply and rub in a thin layer of Rosadan® (metronidazole) Topical Cream twice daily, morning and evening, to entire affected areas after washing.

Areas to be treated should be washed with a mild cleanser before application. Patients may use cosmetics after application of Rosadan® (metronidazole) Topical Cream.

How is Rosadan Cream supplied

Rosadan® (metronidazole) Topical Cream, 0.75% is supplied in a 45 g tube NDC 43538-180-45.

Manufactured for:
MEDIMETRIKS
PHARMACEUTICALS, INC.
383 Route 46 West, Fairfield, NJ 07004-2402 USA
www.medimetriks.com

Manufactured by:
Cosette Pharmaceuticals, Inc.
111 Coolidge Street,
South Plainfield, NJ 07080

IP019-R5

8-0633MDM5
Rev. 09/2019

PRINCIPAL DISPLAY PANEL - 45 g Tube Carton

MEDIMETRIKS
PHARMACEUTICALS, INC.

NDC 43538-180-45

Rx Only
Rosadan®
Metronidazole Topical Cream, 0.75%

NET WT 45 g

PRINCIPAL DISPLAY PANEL - Kit Carton

NDC 43538-181-45

Rx Only
Rosadan®
Metronidazole Topical Cream, 0.75%
CREAM KIT

CONTENTS:
1- Rosadan®
Metronidazole Topical Cream,
0.75% Tube (Net wt. 45 g)
1- Rehyla® Wash
Moisturizing Daily Wash
Bottle (16 fl. oz.)

MEDIMETRIKS
PHARMACEUTICALS, INC.