Erythromycin and Benzoyl Peroxide

INDICATIONS AND USAGE Erythromycin-Benzoyl Peroxide Topical Gel is indicated for the topical treatment of acne vulgaris.

DOSAGE AND ADMINISTRATION Erythromycin-Benzoyl Peroxide 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 Erythromycin-Benzoyl Peroxide Topical Gel is contraindicated in those individuals who have shown hypersensitivity to any of its components.

ADVERSE REACTIONS In controlled clinical trials, the incidence of adverse reactions associated with the use of Erythromycin-Benzoyl Peroxide 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 Oceanside Pharmaceuticals, at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DESCRIPTION Erythromycin-Benzoyl Peroxide Topical Gel contains erythromycin [(3R*,4S*,5S*,6R*,7R*,9R*,11R*,12R*,13S*,14R*)-4-[(2,6-Dideoxy-3- C -methyl-3- O -methyl-α-L- ribo -hexopyranosyl)-oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3-(dimethylamino)-β-D- xylo -hexopyranosyl]oxy] oxacyclotetradecane-2,10-dione]. Erythromycin is a macrolide antibiotic produced from a strain of Saccharopolyspora erythraea (formerly Streptomyces erythreus ). It is a base and readily forms salts with acids. Chemically erythromycin is C 37 H 67 NO 13 . It has the following structural formula: Erythromycin has the molecular weight of 733.94. It is a white crystalline powder and has a solubility of approximately 1 mg/mL in water and is soluble in alcohol at 25°C. Erythromycin-Benzoyl Peroxide Topical Gel also contains benzoyl peroxide for topical use. Benzoyl peroxide is an antibacterial and keratolytic agent. Chemically benzoyl peroxide is C 14 H 10 O 4 . It has the following structural formula: Benzoyl peroxide has the molecular weight of 242.23. It is a white granular powder and is sparingly soluble in water and alcohol and soluble in acetone, chloroform and ether. Each gram of Erythromycin-Benzoyl Peroxide Topical Gel contains, as dispensed, 30 mg (3%) of erythromycin and 50 mg (5%) of benzoyl peroxide in a base of purified water USP, Carbomer Homopolymer Type C, alcohol 20%, sodium hydroxide NF, docusate sodium and fragrance. Chemical Structure Chemical Structure

How Supplied and Compounding Directions: Size (Net Weight) NDC 68682- Benzoyl Peroxide Gel Active Erythromycin Powder (In Plastic Vial) 70% Ethyl Alcohol To Be Added 23.3 grams (as dispensed) 900-23 20 grams 0.8 grams 3 mL 46.6 grams (as dispensed) 901-46 40 grams 1.6 grams 6 mL Prior to dispensing, tap vial until all powder flows freely. Add indicated amount of room temperature 70% ethyl alcohol to vial (to the mark) and immediately shake to completely dissolve erythromycin . Add this solution to gel and stir until homogeneous in appearance (1 to 11⁄2 minutes). Erythromycin-Benzoyl Peroxide Topical Gel should then be stored under refrigeration. Do not freeze. Place a 3-month expiration date on the label. NOTE: Prior to reconstitution, store at room temperature between 15° to 30°C (59° to 86°F). After reconstitution, store under refrigeration between 2° to 8°C (36° to 46°F). Do not freeze. Keep tightly closed. Keep out of reach of children.