Label: ERYTHROMYCIN AND BENZOYL PEROXIDE kit

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 C37H67NO13. 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 C14H10O4. 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.

The exact mechanism by which erythromycin reduces lesions of acne vulgaris is not fully known; however, the effect appears to be due in part to the antibacterial activity of the drug.

Benzoyl peroxide has a keratolytic and desquamative effect which may also contribute to its efficacy. Benzoyl peroxide has been shown to be absorbed by the skin where it is converted to benzoic acid.

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

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

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.

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.

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.

How Supplied and Compounding Directions:

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 1½ minutes). Erythromycin-Benzoyl Peroxide Topical Gel should then be stored under refrigeration. Do not freeze. Place a 3-month expiration date on the label.

Distributed by:
Oceanside Pharmaceuticals, a division of
Bausch Health US, LLC
Bridgewater, NJ 08807 USA

Manufactured by:
Bausch Health Companies Inc.
Laval, Quebec H7L 4A8, Canada

© 2019 Bausch Health Companies Inc. or its affiliates

PLEASE READ COMPLETE
COMPOUNDING DIRECTIONS

NOTE: TAP VIAL UNTIL ALL POWDER FLOWS FREELY. ADD ROOM TEMPERATURE 70% ETHYL ALCOHOL TO VIAL (TO THE MARK) AND IMMEDIATELY SHAKE/DISSOLVE COMPLETELY.

Rev. 06/19

9437503

NDC 68682-901-46

Rx only

Erythromycin-Benzoyl
Peroxide Topical Gel

FOR TOPICAL USE ONLY

One 46.6 g Jar (as dispensed)

OCEANSIDE
PHARMACEUTICALS

NDC 68682-900-23

Rx only

Erythromycin-Benzoyl
Peroxide Topical Gel

FOR TOPICAL USE ONLY

One 23.3 g Jar (as dispensed)

OCEANSIDE
PHARMACEUTICALS

NDC 68682-924-08

Rx only

Erythromycin

NDC 68682-923-23

Rx only

Erythromycin-Benzoyl
Peroxide Topical Gel

FOR TOPICAL USE ONLY

One 23.3 g Jar (as dispensed)

NDC 68682-925-16

Rx only

Erythromycin

NDC 68682-922-46

Rx only

Erythromycin-Benzoyl
Peroxide Topical Gel

FOR TOPICAL USE ONLY

One 46.6 g Jar (as dispensed)