Label: PANOXYL- benzoyl peroxide soap

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 May 20, 2011

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  • Active ingredient (Maximum Strength)

    Benzoyl peroxide 10%

  • Active ingredient (Regular Strength)

    Benzoyl peroxide 5%

  • Purpose

    Acne medication

  • INDICATIONS & USAGE

    Use for the treatment of acne; helps prevent new acne blemishes from forming

  • Warnings

    For external use only

  • Do not use

    • if you have very sensitive skin
    • if you 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

    • using warm water, wash the affected area for 1 to 2 minutes
    • rinse well and pat dry with a clean towel
    • because too much drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 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 controlled room temperature 59° -86°F (15°-30°C).

  • Inactive ingredients

    cetearyl alcohol, cocamidopropyl betaine, glycerin, hydrogenated castor oil, lactic acid, mineral oil, PEG-14M, potassium lauryl sulfate, potassium phosphate, purified water, silica, sodium lauryl sulfate, titanium dioxide, zea mays (corn) starch

  • Questions?

    call 1-888-784-3335 (STIEFEL). Side effects associated with use of this product may be reported to this number.

    Maximum Strength

    Now you can take control of your acne with Maximum Strength PanOxyl® Acne Cleansing Bar, the highest strength of Benzoyl Peroxide (BPO) available without a prescription. The Benzoyl Peroxide in the PanOxyl® Acne Cleansing Bar is the same medicine prescribed by dermatologists.

    The convenient bar form of PanOxyl® gently removes dirt and excess oil to cleanse and unclog pores, making it an excellent choice for the management of acne on the face, chest and back.

    Regular Strength

     Now you can take control of your acne with the PanOxyl® Acne Cleansing Bar. The 5% Benzoyl Peroxide in the PanOxyl® Acne Cleansing Bar is the same medicine prescribed by dermatologists.

    The convenient bar form of PanOxyl® Acne Cleansing Bar gently removes dirt and excess oil to cleanse and unclog pores, making it an excellent choice for the management of acne on the face, chest and back.

    PANOXYL is a registered trademark of Stiefel Laboratories, Inc.

    www.stiefelchc.com

    ©2010 Stiefel Laboratories, Inc.

    Stiefel Laboratories, Inc.

    Research Triangle Park, NC 27709

    Relabeling by:
    Physicians Total Care, Inc.
    Tulsa, OK     74146


  • Principal Display Panel

    NDC 54868-2656-0

    PanOxyl®

    10% Benzoyl Peroxide

    Maximum Strength

    ACNE CLEANSING BAR

    DERMATOLOGIST Recommended Ingredients

    Therapeutic acne control

    FACE

    CHEST

    BACK

    • Benzoyl Peroxide effectively penetrates pores killing the bacteria that cause acne
    • Clears existing acne blemishes and prevents new blemishes from forming


    Net Wt 4 Oz (113 g)

    image of Panoxyl 10% Bar carton label

  • Principal Display Panel

    NDC 54868-2655-0

    PanOxyl®

    5% Benzoyl Peroxide

    Regular Strength

    ACNE CLEANSING BAR

    DERMATOLOGIST Recommended Ingredients

    Therapeutic acne control

    FACE

    CHEST

    BACK

    • Benzoyl Peroxide effectively penetrates pores killing the bacteria that cause acne
    • Clears existing acne blemishes and prevents new blemishes from forming


    Net Wt 4 Oz (113 g)

    image of Panoxyl 5% Bar Carton label
  • INGREDIENTS AND APPEARANCE
    PANOXYL 
    benzoyl peroxide soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-2656(NDC:0145-0983)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE11.3 g
    Inactive Ingredients
    Ingredient NameStrength
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POTASSIUM PHOSPHATE (UNII: B7862WZ632)  
    WATER (UNII: 059QF0KO0R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54868-2656-01 in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333D03/31/2008
    PANOXYL 
    benzoyl peroxide soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-2655(NDC:0145-0982)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE5.65 g
    Inactive Ingredients
    Ingredient NameStrength
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POTASSIUM PHOSPHATE (UNII: B7862WZ632)  
    WATER (UNII: 059QF0KO0R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54868-2655-01 in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333D03/31/2008
    Labeler - Physicians Total Care, Inc. (194123980)
    Establishment
    NameAddressID/FEIBusiness Operations
    Physicians Total Care, Inc.194123980relabel, repack
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