Label: GLYTONE ACNE BPO CLEARING CLEANSER- benzoyl peroxide lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 1, 2021

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

  • Drug Facts

  • Active Ingredients

    Benzoyl Peroxide 4.5%

  • Purpose

    Acne Treatment

  • Use

    For the treatment of acne.

  • Warnings

    For external use only.


    Do not use if you

    • have a 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 medical help or contact a Poison Control Center right away.

  • Directions

    • Dispense a small amount into hand and mix with a little water.
    • Apply a thin layer over entire affected area in a circular motion, rinse thoroughly with warm water two times daily.
    • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two times 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

    Store at room temperature 68-77 o F (25-25 o C). Protect this product from excessive heat and direct sun.

  • Inactive ingredients

    WATER, COCAMIDOPROPYL BETAINE, SODIUM C14-16 OLEFIN SULFONATE, HYDROXYETHYL BEHENAMIDOPROPYL DIMONIUM CHLORIDE, DIPROPYLENE GLYCOL, 1,3-BUTYLENE GLYCOL, BUTYROSPERMUM PARKII (SHEA) BUTTER, XANTHAN GUM, EUPHORBIA CERIFERA (CANDELILLA) WAX, HYDROXYPROPYL METHYLCELLULOSE, PHENOXYETHANOL, ETHYLHEXYLGLYCERIN, PEG-11 AVOCADO GLYCERIDES


  • Principal Display Panel - 200 ml Bottle

    BPO Clearing Cleanser

    GLYTONE

    Acne BPO Clearing

    Cleanser

    4.5

    Encapsulated Benzoyl Peroxide

    200 mL / 6.7 FL. OZ.

  • INGREDIENTS AND APPEARANCE
    GLYTONE ACNE BPO CLEARING CLEANSER 
    benzoyl peroxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64760-712
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE45 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    HYDROXYETHYL BEHENAMIDOPROPYL DIMONIUM CHLORIDE (UNII: 9CO8OUL4TH)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PEG-11 AVOCADO GLYCERIDES (UNII: YLY4A64409)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64760-712-01200 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D03/01/2017
    Labeler - Pierre Fabre USA Inc. (117196928)