Label: ERYTHROMYCIN AND BENZOYL PEROXIDE gel

NOTE: 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 VIGOROUSLY TO COMPLETELY DISSOLVE ERYTHROMYCIN, THEN IMMEDIATELY ADD THIS SOLUTION TO GEL AND STIR UNTIL HOMOGENEOUS IN APPEARANCE (1 TO 1-1/2 MINUTES).

Erythromycin and Benzoyl Peroxide Topical Gel USP

Topical Gel: erythromycin (3%),
benzoyl peroxide (5%)

For Dermatological Use Only – Not for Ophthalmic Use

Reconstitute Before Dispensing

Erythromycin and Benzoyl Peroxide Topical Gel USP contains erythromycin [(3R*, 4S*, 5S*, 6R*, 7R*, 9R*, 11R*, 12R*, 13S*, 14R*)-4-[(2,6-Dideoxy-3-C-methyl-3-0-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 and Benzoyl Peroxide Topical Gel USP 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 and Benzoyl Peroxide Topical Gel USP contains, as dispensed, 30 mg (3%) of erythromycin and 50 mg (5%) of benzoyl peroxide in a base of purified water USP, carbomer 940 NF, ethyl 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 and Benzoyl Peroxide Topical Gel USP is indicated for the topical treatment of acne vulgaris.

Erythromycin and Benzoyl Peroxide Topical Gel USP 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 and Benzoyl Peroxide Topical Gel USP 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 Rising Pharma Holdings, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Erythromycin and Benzoyl Peroxide Topical Gel USP 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.

———PRINCIPAL DISPLAY PANEL 23.3g———

Rising®                                     NDC 64980-328-23

Erythromycin and
Benzoyl Peroxide
Topical Gel USP

FOR TOPICAL USE ONLY

                                                                      Rx only

One 23.3g Jar (as dispensed)

Rising®                                   NDC 64980-328-01

Erythromycin and
Benzoyl Peroxide
Topical Gel USP

FOR TOPICAL USE ONLY

                                                                      Rx only

One 23.3g Jar (as dispensed)

———PRINCIPAL DISPLAY PANEL 46.6g———

Rising®                                 NDC 64980-328-46

Erythromycin and
Benzoyl Peroxide
Topical Gel USP

FOR TOPICAL USE ONLY

                                                                   Rx only

One 46.6g Jar (as dispensed)

Rising®                                   NDC 64980-328-02

Erythromycin and
Benzoyl Peroxide
Topical Gel USP

FOR TOPICAL USE ONLY

                                                                      Rx only

One 46.6g Jar (as dispensed)