Panoxyl
FDA Label NDC 54868-2655

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Physicians Total Care, Inc. for the product Panoxyl (NDC 54868-2655). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (maximum strength), active ingredient (regular strength), purpose, indications & usage, warnings, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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)

      Image Of Panoxyl 5% Bar Carton Label (2655)

      Image Of Panoxyl 5% Bar Carton Label (2655)

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