Benzoazeline 10

Benzoazeline 10
SPL v2
SPL
SPL Set ID 985efa19-bd91-45cd-a2a0-d71ec325e51c
Route
TOPICAL
Published
Effective Date 2026-01-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzoyl Peroxide (1000 mg)
Inactive Ingredients
Water Azelaic Acid Potassium Azeloyl Diglycinate Dimethyl Sulfone Strontium Chloride Hexahydrate Medium-chain Triglycerides Alcohol Glyceryl Stearate Se Propanediol Propylene Glycol Oleic Acid Peg-100 Monostearate Benzyl Benzoate Arachidyl Alcohol Cetearyl Glucoside Cetostearyl Alcohol Xylitol Anhydroxylitol Docosanol Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%) Arachidyl Glucoside Phenoxyethanol Xylitylglucoside Caprylyl Glycol Dextrose Monohydrate Edetate Disodium Anhydrous

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-03-01

Description

Drug Facts

Purpose

Acne Medication


Medication Information

Purpose

Acne Medication

Description

Drug Facts

Uses
  • For the treatment of acne.
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.

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

For external use only.

Active Ingredient

Benzoyl Peroxide 10%

Do Not Use If You
  • have very sensitive skin.
  • are sensitive to benzoyl peroxide.
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.

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.
Principal Display Panel 50 Ml Tube Carton

no

on

AESTHETICS

BenzoAzeline 10

ACNE TREATMENT

+ DERMSHIELD™

NDC 78863-1310-1

50 mL / 1.75 Fl. Oz. ℮


Structured Label Content

Uses
  • For the treatment of acne.
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Acne Medication

Warnings

For external use only.

Active Ingredient

Benzoyl Peroxide 10%

Do Not Use If You (Do not use if you)
  • have very sensitive skin.
  • are sensitive to benzoyl peroxide.
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.

When Using This Product (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 (Stop use and ask a doctor if)
  • irritation becomes severe.
Principal Display Panel 50 Ml Tube Carton (PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton)

no

on

AESTHETICS

BenzoAzeline 10

ACNE TREATMENT

+ DERMSHIELD™

NDC 78863-1310-1

50 mL / 1.75 Fl. Oz. ℮


Advanced Ingredient Data


Raw Label Data

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