Erythromycin and Benzoyl Peroxide

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

DOSAGE AND ADMINISTRATION 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. How Supplied and Compounding Directions Size (Net weight) NDC Benzoyl Peroxide Gel Active Erythromycin Powder (In Plastic Vial) 70% Ethyl Alcohol To Be Added 23.3 grams (as dispensed) 64980-328-01 20 grams 0.8 grams 3 mL 46.6 grams (as dispensed) 64980-328-02 40 grams 1.6 grams 6 mL Pharmacist Important - 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 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˚ and 30˚C (59˚-86˚F). After reconstitution , store under refrigeration between 2˚and 8˚C (36˚-46˚F). Do not freeze. Keep tightly closed. Keep out of the reach of children. Rx only Manufactured by: Lyne Laboratories, Inc., Brockton, MA 02301 Manufactured for: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816 Revised : 08/2025 PIR32846-00

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

WARNINGS 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.

ADVERSE REACTIONS 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.

Pregnancy: Teratogenic Effects: Animal reproduction studies have not been conducted with Erythromycin and Benzoyl Peroxide Topical Gel USP or benzoyl peroxide. There was no evidence of teratogenicity or any other adverse effect on reproduction in female rats fed erythromycin base (up to 0.25% diet) prior to and during mating, during gestation and through weaning of two successive litters. There are no well-controlled trials in pregnant women with Erythromycin and Benzoyl Peroxide Topical Gel USP. It also is not known whether Erythromycin and Benzoyl Peroxide Topical Gel USP can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Erythromycin and Benzoyl Peroxide Topical Gel USP should be given to a pregnant woman only if clearly needed.