Label: CARING MILL ACNE TREATMENT- benzoyl peroxide cream

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

Drug Label Information

Updated January 12, 2024

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  • Drug Facts

  • Active Ingredient

    Benzoyl Peroxide 10%

    Purpose

    Acne medication

  • Use

    For the management of acne.

  • Warnings

    For external use only.

    When using this product

    • Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same timr. If irritation occurs, only use one topical acne medication at a time
    • Avoid unnecessary sun exposure and use sunscreen
    • Avoid contact with the eyes, lips, and mouth. If contact occurs, flush thorughly with water.
    • Avoid contact with hair and dyed products, 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 use and ask a doctor if

    • irritation becomes severe.

    Keep out of reach of children.

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

  • 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 applicaiton to once a day or every other day 
    • If going outside, apply sunscreen after using this product. If irritaion or sensitivity develops, stop use of both products and ask a doctor.
  • Other information

    Protect from excessive heat (104°F/40°C).

  • Inactive ingredients

    Water, Polyacrylate Crosspolymer-11, Laureth-4, Hydroxypropyl Methylcellulose, Silica, Methicone, Sodium Hydroxide, Disodium EDTA.

  • Package Labeling:

    Outer Package2Inner Package2

  • INGREDIENTS AND APPEARANCE
    CARING MILL ACNE TREATMENT 
    benzoyl peroxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81522-951
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE100 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    AMMONIUM ACRYLOYL DIMETHYLTAURATE/METHACRYLATE, DIMETHYLACRYLAMIDE AND METHACRYLIC ACID COPOLYMER, PPG-3 GLYCERYL TRIACRYLATE CROSSLINKED (100000 MW) (UNII: WR7H9IW2XX)  
    LAURETH-4 (UNII: 6HQ855798J)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    METHICONE (20 CST) (UNII: 6777U11MKT)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81522-951-0128 g in 1 TUBE; Type 0: Not a Combination Product01/20/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00601/20/2024
    Labeler - FSA Store Inc. (049283340)
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