MEDPURA Benzoyl Peroxide Aqueous Base, Acne Treatment Gel 100 mg/mL

Benzoyl Peroxide · GEL · Akron Pharma Inc.

No Recall HistoryCurrently in Shortage

Plain English

MEDPURA Benzoyl Peroxide Aqueous Base, Acne Treatment Gel is a prescription gel containing benzoyl peroxide at 100 mg/mL, taken topical. Manufactured by Akron Pharma Inc..

Key Facts

Brand Name: MEDPURA Benzoyl Peroxide Aqueous Base, Acne Treatment Gel
Generic Name: Benzoyl Peroxide
NDC Code (Product): 71399-9474
Manufacturer: Akron Pharma Inc.
Strength: 100 mg/mL
Dosage Form: GEL
Route: TOPICAL
Marketing Status: HUMAN OTC DRUG
Application #: M006
Marketing Start: 09/13/2024

Recall History

No Recall History

Side Effects Reported to FDA

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

drug ineffective137 reports

rash88 reports

erythema69 reports

pain65 reports

pruritus64 reports

off label use63 reports

fatigue61 reports

nausea61 reports

anxiety60 reports

acne54 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Use for the treatment of acne

Dosage & Administration

Directions Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below. clean the skin thoroughly before applying this product cover the entire affected area with a thin layer one to three times daily because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor if bothersome dryness or peeling occurs, reduce application to once a day or every other day if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

Warnings

Warnings For external use only Do not use this medication if you have very sensitive skin or if you are sensitive to benzoyl peroxide. When using this product skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time. avoid unnecessary sun exposure and use a sunscreen avoid contact with the eyes, lips, and mouth avoid contact with hair and dyed fabrics, which may be bleached by this product skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Frequently Asked Questions

What is MEDPURA Benzoyl Peroxide Aqueous Base, Acne Treatment Gel used for?

MEDPURA Benzoyl Peroxide Aqueous Base, Acne Treatment Gel contains Benzoyl Peroxide. It is a gel taken topical. Consult your doctor for specific uses.

Is MEDPURA Benzoyl Peroxide Aqueous Base, Acne Treatment Gel a controlled substance?

MEDPURA Benzoyl Peroxide Aqueous Base, Acne Treatment Gel is not classified as a controlled substance by the DEA.

What is the generic name for MEDPURA Benzoyl Peroxide Aqueous Base, Acne Treatment Gel?

The generic name for MEDPURA Benzoyl Peroxide Aqueous Base, Acne Treatment Gel is Benzoyl Peroxide. There are 12 other brand versions of Benzoyl Peroxide.

What is the NDC code for MEDPURA Benzoyl Peroxide Aqueous Base, Acne Treatment Gel 100 mg/mL?

The NDC (National Drug Code) for MEDPURA Benzoyl Peroxide Aqueous Base, Acne Treatment Gel 100 mg/mL is 71399-9474, listed by Akron Pharma Inc..

Product NDC

71399-9474

Package NDC

71399-9474-5

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

Data from openFDA · Public domain (CC0 1.0)