BenzoAzeline 10

Manufacturer
Noon Aesthetics M.R. Ltd
Effective date
2026-01-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:33:58

Label at a glance#

ProductBenzoAzeline 10
Active ingredientBENZOYL PEROXIDE
Label structure10 sections

Indications and uses

For the treatment of acne.

Dosage and administration

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...

Storage and handling

Protect this product form excessive heat and direct sun.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzoyl Peroxide 10%

Purpose

OTC - PURPOSE SECTION

Acne Medication

Uses

INDICATIONS & USAGE SECTION

  • For the treatment of acne.

Warnings

WARNINGS SECTION

For external use only.

Do not use if you

OTC - DO NOT USE SECTION

  • have very sensitive skin.
  • are sensitive to benzoyl peroxide.

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • irritation becomes severe.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

  • If swallowed, get help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

SPL UNCLASSIFIED SECTION

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

STORAGE AND HANDLING SECTION

Protect this product form excessive heat and direct sun.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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.

SPL UNCLASSIFIED SECTION

Developed + Dist by
noon
AESTHETICS

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

no
on
AESTHETICS

BenzoAzeline 10
ACNE TREATMENT

+ DERMSHIELD™

NDC 78863-1310-1

50 mL / 1.75 Fl. Oz. ℮

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton
PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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b382b4e1-6b48-45f6-bffc-e61b00b0ce19Product name320250317
cb89b86a-369e-4204-8910-ae797c503af3Product name120230706
d9d61457-6a5a-41fc-b418-e5479a2904b7Product name220230303
32012d5c-25ac-49c7-9d4c-1313177fff7cProduct name120230112
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
6c6fc281-9445-2e9e-1c29-a09ddbc4299cProduct name220200213
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78863-1310-1BenzoAzeline 1050 mL in 1 TUBECREAM502
78863-1310-1BenzoAzeline 101 in 1 CARTONCREAM12
78863-1310-2BenzoAzeline 1015 mL in 1 BOTTLE, PUMPCREAM152
78863-1310-2BenzoAzeline 101 in 1 CARTONCREAM12

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78863-131078863-1310-1, 78863-1310-2

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BenzoAzeline 10BENZOYL PEROXIDENoon Aesthetics M.R. Ltd985efa19-bd91-45cd-a2a0-d71ec325e51c2026-01-16WarningsExact identifier
ndc (package): 78863-1310-1
ndc (package): 78863-1310-2
ndc (product): 78863-1310
ndc11 (package): 78863131001
ndc11 (package): 78863131002
spl id: 256eec2c-7298-46d3-93bc-e7c41375fd8a
spl set id: 985efa19-bd91-45cd-a2a0-d71ec325e51c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.