Label: NIGHTTIME CONTROL- benzoyl peroxide lotion

  • NDC Code(s): 76458-333-02
  • Packager: Circadia by Dr Pugliese, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 15, 2023

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

  • Active ingredient

    Benzoyl Peroxide 5%

  • Purpose

    Acne Treatment

  • Uses

    for the treatment of acne

  • Warnings

    For external use only

    Do not use if you

    When using this product

    • have very sensitive skin
    • are sensitive to benzoyl peroxide
    • 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
    • at the same time as other topical acne medications, increased dryness or irritation is more likely to occur. If this occurs, only one medication should be used unless directed by a doctor.
  • Stop use and ask a doctor

    if irritation becomes severe.

    ask a doctor before using. If pregnant or breastfeeding,

  • Keep Out of Reach of Children

    In case of accidental ingestion, get medical help or contact a Poison Control Center Immediately.

  • Directions

    • Cleanse skin thoroughly before applying Nighttime Control.
    • Cover entire affected area with a thin layer 1 to 3 times daily.
    • Because excessive drying of the skin may occur, start with 1 application every day, or every other day, gradually increasing to 2 or 3 times a day if needed or as directed by a doctor.
    • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
    • Follow directions on sunscreen labeling. If sensitivity develops, discontinue use of both products and consult a doctor. If going outside apply a sunscreen after using this product.

  • Inactive ingredients

    Water, hexyldecanol, methyl propanediol, cetearyl alcohol, glyceryl stearate, PEG-100 stearate, cetereth-20, cetearyl glucoside, dimethicone, carbomer, tocopheryl acetate, allantoin, sodium hydroxide, caprylyl glycol, hexylene glycol, methylisothiazolinone

  • Other Information

    • Keep tightly closed
    • Keep away from heat
  • Questions?

    Call toll-free (800) 630-4710

  • Package/Label Principal Display Panel

    Nighttime Control Benzoyl Peroxide Lotion

    Advanced Professional Skincare

    2 fl oz (59 ml)

    Circadia by Dr. Pugliese, Inc. 8371 Route 183 Bethel, PA 19507 Circadia.com

    Label

  • INGREDIENTS AND APPEARANCE
    NIGHTTIME CONTROL 
    benzoyl peroxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76458-333
    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
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    WATER (UNII: 059QF0KO0R)  
    HEXYLDECANOL (UNII: 151Z7P1317)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERYL 1-STEARATE (UNII: 258491E1RZ)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALLANTOIN (UNII: 344S277G0Z)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76458-333-021 in 1 CARTON07/15/2012
    159 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00607/15/2012
    Labeler - Circadia by Dr Pugliese, Inc. (013694423)
    Establishment
    NameAddressID/FEIBusiness Operations
    Circadia by Dr Pugliese, Inc.013694423manufacture(76458-333)