EPSOLAY 50 mg/g

Benzoyl Peroxide · CREAM · Galderma Laboratories, L.P.

No Recall HistoryCurrently in Shortage

Plain English

EPSOLAY is a cream containing benzoyl peroxide at 50 mg/g, taken topical. Manufactured by Galderma Laboratories, L.P..

Key Facts

Brand Name: EPSOLAY
Generic Name: Benzoyl Peroxide
NDC Code (Product): 0299-5890
Manufacturer: Galderma Laboratories, L.P.
Strength: 50 mg/g
Dosage Form: CREAM
Route: TOPICAL
Marketing Status
Application #: NDA214510
Marketing Start: 05/09/2022

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective140 reports

rash90 reports

erythema80 reports

pruritus70 reports

off label use67 reports

pain65 reports

fatigue61 reports

nausea61 reports

anxiety60 reports

acne56 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE EPSOLAY is indicated for the treatment of inflammatory lesions of rosacea in adults. EPSOLAY is indicated for the treatment of inflammatory lesions of rosacea in adults. ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Before initial use, prime the pump until the first drop of cream is released. Apply a pea-sized amount of EPSOLAY once daily in a thin layer to each area of the face (forehead, chin, nose, each cheek) on clean and dry skin. Avoid the eyes, lips and mouth. Wash hands after application. EPSOLAY may bleach hair or colored fabric. EPSOLAY is for topical use only. Not for oral, ophthalmic, or intravaginal use. Discard unused EPSOLAY 60 days after first use. Apply to the affected areas once daily. ( 2 ) Wash hands after application. ( 2 ) Not for oral, ophthalmic, or intravaginal use. ( 2 )

Contraindications

4 CONTRAINDICATIONS EPSOLAY is contraindicated in patients with a history of hypersensitivity reactions to benzoyl peroxide or any components of the formulation in EPSOLAY [ see Warnings and Precautions ( 5.1 ) ]. A history of a serious hypersensitivity reactions to benzoyl peroxide or any component of the formulation in EPSOLAY. ( 4 )

Adverse Reactions

6 ADVERSE REACTIONS Most common adverse reactions (incidence ≥ 1%) are application site reactions: pain, erythema, pruritis and edema. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Galderma Laboratories, L.P. at 1-866-735-4137 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In two randomized, double-blind, vehicle-controlled trials, adult subjects with rosacea applied EPSOLAY (N = 488) or vehicle (N = 234) once daily for 12 weeks. The majority of subjects were Caucasian (93%) and female (73%) with a mean age of 51 years. Table 1 presents the most common adverse reactions occurring in ≥ 1% of subjects treated with EPSOLAY and more frequently than in subjects treated with vehicle. Table 1: Adverse Reactions Occurring in ≥ 1% of Subjects Treated with EPSOLAY and with Greater Frequency than Subjects Treated with Vehicle * Application site edema includes: application site swelling and a…

Frequently Asked Questions

What is EPSOLAY used for?

EPSOLAY contains Benzoyl Peroxide. It is a cream taken topical. Consult your doctor for specific uses.

Is EPSOLAY a controlled substance?

EPSOLAY is not classified as a controlled substance by the DEA.

What is the generic name for EPSOLAY?

The generic name for EPSOLAY is Benzoyl Peroxide. There are 12 other brand versions of Benzoyl Peroxide.

What is the NDC code for EPSOLAY 50 mg/g?

The NDC (National Drug Code) for EPSOLAY 50 mg/g is 0299-5890, listed by Galderma Laboratories, L.P..

Product NDC

0299-5890

Package NDC

0299-5890-00

Other Benzoyl Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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