Drugplain

BenzoAzeline 10 1000 mg/mL

BENZOYL PEROXIDE · CREAM · Noon Aesthetics M.R. Ltd

No Recall HistoryCurrently in Shortage
Plain English

BenzoAzeline 10 is a cream containing benzoyl peroxide at 1000 mg/mL, taken topical. Manufactured by Noon Aesthetics M.R. Ltd.

Key Facts

Brand Name
BenzoAzeline 10
Generic Name
BENZOYL PEROXIDE
NDC Code (Product)
78863-1310
Manufacturer
Noon Aesthetics M.R. Ltd
Strength
1000 mg/mL
Dosage Form
CREAM
Route
TOPICAL
Marketing Status
Application #
M020
Marketing Start
03/01/2024

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

Uses 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 if you have very sensitive skin. 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. Stop use and ask a doctor if irritation becomes severe. Keep out of reach of children. If swallowed, get help or contact a Poison Control Center right away.

Frequently Asked Questions

What is BenzoAzeline 10 used for?

BenzoAzeline 10 contains BENZOYL PEROXIDE. It is a cream taken topical. Consult your doctor for specific uses.

Is BenzoAzeline 10 a controlled substance?

BenzoAzeline 10 is not classified as a controlled substance by the DEA.

What is the generic name for BenzoAzeline 10?

The generic name for BenzoAzeline 10 is BENZOYL PEROXIDE. There are 12 other brand versions of BENZOYL PEROXIDE.

What is the NDC code for BenzoAzeline 10 1000 mg/mL?

The NDC (National Drug Code) for BenzoAzeline 10 1000 mg/mL is 78863-1310, listed by Noon Aesthetics M.R. Ltd.