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  5. Label Information: Panoxyl

FDA Label for Panoxyl

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (MAXIMUM STRENGTH)
    2. ACTIVE INGREDIENT (REGULAR STRENGTH)
    3. PURPOSE
    4. INDICATIONS & USAGE
    5. WARNINGS
    6. DO NOT USE
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR IF
    9. KEEP OUT OF REACH OF CHILDREN.
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS?
    14. OTHER
    15. PRINCIPAL DISPLAY PANEL

Panoxyl Product Label

The following document was submitted to the FDA by the labeler of this product Physicians Total Care, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


Other



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 - 2656

    image of Panoxyl 10% Bar carton label - 2656

    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)


* Please review the disclaimer below.