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Drug Facts
Benzoazeline Forte Cream
FDA Label NDC 78863-1180
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Noon Aesthetics M.r. Ltd for the product Benzoazeline Forte (NDC 78863-1180). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredients, purpose, indications & usage, warnings, otc - when using, otc - do not use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Benzoyl Peroxide 10%
Purpose
Acne treatment
Indications & Usage
Use for the treatment of acne
Warnings
For external use only.
Otc - When Using
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 at a time.
Otc - Do Not Use
Do not use if you: have very sensitive skin, are sensitive to benzoyl peroxide when using this product. 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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get help or contact a Poison Control Center right away.
Directions
Cleanse the skin thoroughly before applying this product. Cover the entire affected area with a thin layer one to three times daily. 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 of peeling occurs, reduce application to one a day or every other day. If irritation or sensitivity develops, stop use of both products and ask a doctor.
If going outside, apply sunscreen after using this product.
Inactive Ingredients
Water, Azelaic Acid, Strontium Nitrate, Potassium Azeloyl Diglycinate, Isononyl Isononanoate, Cyclopentasiloxane, Glycerin, Propanediol, Ethoxydiglycol, Dimethyl Sulfone, Glyceryl Stearate, PEG-100 Stearate, Polysorbate 20, Cetyl Palmitate, Phenoxyethanol, Dimethicone, Arachidyl Alcohol, Cetyl Alcohol, Behenyl Alcohol, Arachidyl Glucoside, Caprylyl Glycol, Sodium phytate, Glucose, Alcohol
Other Information
Protect this product form excessive heat and direct sun.
Questions Or Comments?
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Or call Toll Free 1-833-666-6246
Principal Display Panel - 50 Gr Tube Carton
NOON ™
BenzoAzelin
Forte
with DermShield ™
Treatment for Acne,
Bumpy Skin with
Papules and Associated
Redness (Rose-Red
Papules / Red Rash)
Azelaic Acid 13%
Azeloglicina 10%
Benzoyl Peroxide 10%
PARACEUTICAL
50 gr / 1.76 Oz e
Principal Display Panel (50 gr Tube Carton)
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