FOR TOPICAL USE ONLY (NOT FOR OPHTHALMIC USE)

Rx Only

Rosadan® (metronidazole) Gel contains metronidazole, USP, at a concentration of 7.5 mg per gram (0.75%) in a gel consisting of carbomer homopolymer NF, edetate disodium, methylparaben, propylene glycol, propylparaben, purified water, and sodium hydroxide. Metronidazole is classified therapeutically as an antiprotozoal and antibacterial agent.

Chemically, metronidazole is named 2-methyl-5-nitro-1H-imidazole-1-ethanol and has the following structure:

Bioavailability studies on the topical administration of 1 gram of Rosadan® (metronidazole) Gel (7.5 mg of metronidazole) to the face of 10 rosacea patients showed a maximum serum concentration of 66 nanograms per milliliter in one patient. This concentration is approximately 100 times less than concentrations afforded by a single 250 mg oral tablet. The serum metronidazole concentrations were below the detectable limits of the assay at the majority of time points in all patients. Three of the patients had no detectable serum concentrations of metronidazole at any time point. The mean dose of gel applied during clinical studies was 600 mg which represents 4.5 mg of metronidazole per application. Therefore, under normal usage levels, the formulation affords minimal serum concentrations of metronidazole. The mechanisms by which Rosadan® (metronidazole) Gel acts in the treatment of rosacea are unknown, but appear to include an anti-inflammatory effect.

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

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

The following adverse experiences have been reported with the topical use of metronidazole: burning, skin irritation, 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 orwww.fda.gov/medwatch.

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

Areas to be treated should be cleansed before application of Rosadan ® (metronidazole) Gel. Patients may use cosmetics after application of Rosadan ® (metronidazole) Gel.

Rosadan ® (metronidazole) Gel USP, 0.75% is supplied in a 45 g tube NDC 43538-182-45

Manufactured for:
MEDIMETRIKS
PHARMACEUTICALS, INC.

383 Route 46 West
Fairfield, NJ 07004-2402
www.medimetriks.com

Manufactured by:
G&W Laboratories, Inc.
South Plainfield, NJ 07080

8-0637BFMDMLNC2
Rev. 08/2019
GW 7313
IP024-R4

MEDIMETRIKS
PHARMACEUTICALS, INC.

NDC 43538-182-45

Rx Only

Rosadan® GEL
Metronidazole Gel USP, 0.75%

NET WT 45 g

NDC 43538-183-45

Rx Only
Rosadan®
Metronidazole Gel USP, 0.75%
GEL KIT

CONTENTS:

1-

Rosadan®
Metronidazole Gel USP,
0.75% Tube (Net wt. 45 g)

1-

Rehyla® Wash
Moisturizing Daily Wash
Bottle (16 fl. oz.)

MEDIMETRIKS
PHARMACEUTICALS, INC.