Label: BENZOAZELINE 5- benzoyl peroxide cream

  • NDC Code(s): 78863-1300-1, 78863-1300-2
  • Packager: Noon Aesthetics M.R. Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 12, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • 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.

    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.

  • SPL UNCLASSIFIED SECTION

    Developed + Dist by
    noon
    AESTHETICS

  • PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton

    no
    on
    AESTHETICS

    BenzoAzeline 5
    ACNE TREATMENT

    + DERMSHIELD™

    NDC 78863-1300-1

    50 mL / 1.75 Fl. Oz. ℮

    PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton
  • INGREDIENTS AND APPEARANCE
    BENZOAZELINE 5 
    benzoyl peroxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78863-1300
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE500 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    AZELAIC ACID (UNII: F2VW3D43YT)  
    POTASSIUM AZELOYL DIGLYCINATE (UNII: N02RVN6NYP)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    STRONTIUM CHLORIDE HEXAHYDRATE (UNII: O09USB7Z44)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    OLEIC ACID (UNII: 2UMI9U37CP)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    XYLITOL (UNII: VCQ006KQ1E)  
    ANHYDROXYLITOL (UNII: 8XWR7NN42F)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    XYLITYLGLUCOSIDE (UNII: O0IEZ166FB)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DEXTROSE MONOHYDRATE (UNII: LX22YL083G)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78863-1300-11 in 1 CARTON03/01/2024
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:78863-1300-21 in 1 CARTON03/01/2024
    215 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM00603/01/2024
    Labeler - Noon Aesthetics M.R. Ltd (600185560)
    Establishment
    NameAddressID/FEIBusiness Operations
    Noon Aesthetics M.R. Ltd600185560MANUFACTURE(78863-1300)
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