Label: PANOXYL- benzoyl peroxide soap

  • NDC Code(s): 0316-0264-01, 0316-0264-04
  • Packager: Crown Laboratories
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 16, 2024

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

  • Active ingredient

    Benzoyl peroxide 10%

  • Purpose

    Acne medication

  • Use

    • for the treatment of acne
  • Warnings

    For external use only

    Do not use if you

    • have very sensitive skin
    • are sensitive to benzoyl peroxide

    When using 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.
    • 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

    Stop use and ask a doctor if

    • irritation becomes severe

    If pregnant or breast-feeding,

    ask a health professional before use.

    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
    • work into a lather
    • cover the entire affected area with a thin layer and rinse thoroughly one to three times daily
    • pat dry
    • 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 sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
  • Other information

    • Store at 20 o - 25 oC (68 o - 77 oF) [see USP Controlled Room Temperature].
  • Inactive ingredients

    Aqua, Cetearyl Alcohol, Decyl Glucoside, Dextrin, Glycerin, Sodium Chloride, Sodium Cocoyl Isethionate, Tetrasodium Glutamate
    Diacetate

  • Questions?

    call 1-833-279-6522

  • Panoxyl Acne Treatmet Bar Carton

    new

    NDC 0316-0264-04

    DERMATOLOGIST RECOMMENDED

    PanOxyl ®

    ACNE TREATMENT BAR

    10% Benzoyl Peroxide

    • Deep Cleaning Face and Body Bar
    • Clears Existing Acne and Helps Prevent New Breakouts from Forming
    • Maximum Strength without a Prescription

    Net wt. 4 oz (113 g)

    PanOxyl Acne Treatment Bar

  • INGREDIENTS AND APPEARANCE
    PANOXYL 
    benzoyl peroxide soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0316-0264
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE12.6 g  in 113 g
    Inactive Ingredients
    Ingredient NameStrength
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    ICODEXTRIN (UNII: 2NX48Z0A9G)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0316-0264-04113 g in 1 CARTON; Type 0: Not a Combination Product07/01/2023
    2NDC:0316-0264-0143 g in 1 CARTON; Type 0: Not a Combination Product02/23/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00607/01/2023
    Labeler - Crown Laboratories (079035945)