Erythromycin and benzoyl peroxide

FDA label, Rising Pharma Holdings, Inc., topical, effective 2025-09-05. Full label on DailyMed

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From MedlinePlus, U.S. National Library of Medicine

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Macrolide Antimicrobial, Macrolide

Dosing in kidney impairment

This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.

Preparation and administration

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.

Pregnancy and lactation

Pregnancy

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.

Lactation

Nursing Women: It is not known whether Erythromycin and Benzoyl Peroxide Topical Gel USP is excreted in human milk after topical application. However, erythromycin is excreted in human milk following oral and parenteral erythromycin administration. Therefore, caution should be exercised when erythromycin is administered to a nursing woman.

For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.

Supply and cost

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