Benzoazeline 5 Cream
FDA Label NDC 78863-1300

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 5 (NDC 78863-1300). 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 ingredient, purpose, uses, warnings, do not use if you, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Developed + Dist by
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AESTHETICS

Active Ingredient

Benzoyl Peroxide 5%

Purpose

Acne Medication

Uses

  • For the treatment of acne.

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.

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

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.

Other Information

Protect this product form excessive heat and direct sun.

Inactive Ingredients

Water (Aqua), Azelaic Acid, Strontium Chloride Hexahydrate, Dimethyl Sulfone, Potassium Azeloyl Diglycinate, PropanedioI, Propylene Glycol, Ethanol, Oleic Acid, Glyceryl Stearate, PEG-100 Stearate, Benzyl Benzoate, Arachidyl Alcohol, Cetearyl Glucoside, Cetearyl Alcohol, Xylitol, Anhydroxylitol, Phenoxyethanol, Behenyl Alcohol, Hydroxyethyl Acrylate/ Sodium Acryloyldimethyl Taurate Copolymer, Arachidyl Glucoside, Xylitylglucoside, Disodium EDTA, Caprylyl Glycol, Glucose.

Principal Display Panel - 50 Ml Tube Carton

no
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AESTHETICS

BenzoAzeline 5
ACNE TREATMENT

+ DERMSHIELD™

NDC 78863-1300-1

50 mL / 1.75 Fl. Oz. ℮

Principal Display Panel (50 mL Tube Carton)

Principal Display Panel (50 mL Tube Carton)

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