Label: MDACNE CUSTOMIZED ACNE TREATMENT BENZOYL PEROXIDE- benzoyl peroxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 26, 2024

If you are a consumer or patient please visit this version.

View All Sections
  • DRUG FACTS:

  • Active Ingredient:

    Benzoyl Peroxide 5.0%

    Purpose

    Acne Treatment

  • Indications:

    • For the treatment of acne.
    • Clears up acne pimples and blemishes, and allows skin to heal. Helps prevent new pimples and blemishes from forming.
  • Warnings:

    For external use only.

    When using this product

    • skin irritation and dryness is more likely to occur if you use another topical medication at the same time. If irritation occurs, use only one topical acne medication at a time.
    • avoid unnecessary sun expodure and use a sunscreen.
    • avoid contact with 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.

    Do not use if you

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

    Stop using and ask a doctor

    is irritation becomes severe.

    Keep out of reach of children.

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

    If pregnant or breastfeeding,

    ask a health professional before use.

  • Directions:

    • 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 sun sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
  • Other information:

    Store in a cool, dry place below 20ºC (70ºF).

  • Inactive Ingredients:

    Aqua (Deionized Water), Ascorbic Acid (Vitamin C), C12-15 Alkyl Benzoate, Camellia Sinensis (Green Tea) Extract, Caprylyl Glycol, Cetearyl Alcohol, Cucumis Sativus (Cucumber) Fruit Extract, Cyclopentasiloxane, Cyclotetrasiloxane, Dimethicone, Glycerin, Glycyrrhiza Glabra (Licorice) Root Extract, Hexylene Glycol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Lavandula Angustifolia (Lavender) Oil, Magnesium Aluminum Silicate, PEG 150 Distearate, Phenoxyethanol, Polysorbate 80, Potassium Sorbate, Propylene Glycol, Steareth-2, Steareth 20, Tetrasodium EDTA, Tocopheryl Acetate (Vitamin E), Zemea (Com) Propanediol.

  • Questions:

    Contact us at support@mdacne.com

  • Package Labelling:

    Outer Label0.jpgInner Label.jpg

  • INGREDIENTS AND APPEARANCE
    MDACNE CUSTOMIZED ACNE TREATMENT BENZOYL PEROXIDE 
    benzoyl peroxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71804-536
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CUCUMBER (UNII: YY7C30VXJT)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CYCLOMETHICONE 4 (UNII: CZ227117JE)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STEARETH-2 (UNII: V56DFE46J5)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71804-536-001 in 1 BOX09/12/2024
    115 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00609/12/2024
    Labeler - MDAlgorithms Inc (080479826)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!