Label: CLARITY CLEAR SKIN SOLUTIONS ACNE SPOT TREATMENT- benzoyl peroxide cream

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

Drug Label Information

Updated May 24, 2024

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

  • Active Ingredient

    Benzoyl peroxide 10%

  • Purpose

    Acne Treatment

  • INDICATIONS & USAGE

    Uses for the treatment and management of acne

  • Warnings

    For external use only.

  • DO NOT USE

    Do not use if you

    • have very sensitive skin
    • are sensitive to benzoyl peroxide
  • WHEN USING

    When using this product

    • skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. If this occurs, only one medication should be used unless otherwise directed by a doctor.
    • avoid unnecessary sun exposure 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 lower concentration.
  • STOP USE

    Stop use and ask a doctor if excessive irritation of the skin develops

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away. Avoid contact with eyes. If contact occurs, flush thoroughly with water.

  • DOSAGE & ADMINISTRATION

    Directions

    • cleanse and tone skin thoroughly before application
    • cover the entire affected area with a thin layer 1-3 times daily
    • because excessive drying of the skin may occur, start with one application daily, and then gradually increase to two or three times daily if needed or as directed by a doctor
    • if bothersome dryness or peeling occurs, reduce daily 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 and ask a doctor.
    • 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 above.

    Other Information Store at room temperature 68-77°. Protect from freezing.

  • INACTIVE INGREDIENT

    Aqua (Water/Eau), Benzoyl Peroxide Gel, Glycerin, Panthenol, Ethyl Macadamiate, Cetyl Alcohol, Stearic Acid, Niacinamide, Polyglyceryl-3 Methyl Glucose Distearate, Glyceryl Stearate, PEG-100 Stearate, Cetearyl Alcohol, Steareth-21, Phenoxyethanol, Bisabolol, Polysorbate 60, Steareth-2, Xanthan Gum, Allantoin, Potassium Sorbate, Chlorella Vulgaris Extract.

  • PRINCIPAL DISPLAY PANEL

    Sei Bella Clarity Clear Precision Acne Spot Treatment (IFP) drug facts jpg.jpgSei Bella Clarity Clear Precision Acne Spot Treatment (IFP) label jpg.jpg

  • INGREDIENTS AND APPEARANCE
    CLARITY CLEAR SKIN SOLUTIONS  ACNE SPOT TREATMENT
    benzoyl peroxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-402
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE1.5 g  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    STEARETH-2 (UNII: V56DFE46J5)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ALLANTOIN (UNII: 344S277G0Z)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CHLORELLA VULGARIS (UNII: RYQ4R60M02)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARETH-21 (UNII: 53J3F32P58)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYL MACADAMIATE (UNII: ANA2NCS6V1)  
    WATER (UNII: 059QF0KO0R)  
    POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54473-402-0115 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product01/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00601/01/2024
    Labeler - Melaleuca, Inc. (139760102)
    Registrant - Melaleuca, Inc. (079711683)
    Establishment
    NameAddressID/FEIBusiness Operations
    Melaleuca, Inc.079711683manufacture(54473-402)