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PanOxyl (Physicians Total Care, Inc.)

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SOAP 1 SOAP in 1 CARTON (54868-2655-0) Label Information

Complete PanOxyl Information

  • 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 Type HUMAN OTC DRUG Item Code (Source) NDC:54868-2656(NDC:0145-0983)
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 11.3 g
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color WHITE Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54868-2656-0 1 in 1 CARTON
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333D 03/31/2008
    PANOXYL 
    benzoyl peroxide soap
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:54868-2655(NDC:0145-0982)
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 5.65 g
    Inactive Ingredients
    Ingredient Name Strength
    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
    Color WHITE Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54868-2655-0 1 in 1 CARTON
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333D 03/31/2008
    Labeler - Physicians Total Care, Inc. (194123980)
    Establishment
    Name Address ID/FEI Business Operations
    Physicians Total Care, Inc. 194123980 relabel, repack