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Panoxyl Soap

Generic Name: benzoyl peroxide
Dosage Form: soap

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 Facts

Active ingredient

Benzoyl peroxide 10%

Purpose

Acne medication

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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.

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.

PANOXYL is a registered trademark of Stiefel Laboratories, Inc.

www.stiefelchc.com

©2010 Stiefel Laboratories, Inc.

Stiefel Laboratories, Inc.

Research Triangle Park, NC 27709

Principal Display Panel

NDC 0145-0983-05

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

Stiefel

Net Wt 4 Oz (113 g)

PANOXYL 
benzoyl peroxide soap
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0145-0983
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 100 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
CETOSTEARYL ALCOHOL  
COCAMIDOPROPYL BETAINE  
GLYCERIN  
HYDROGENATED CASTOR OIL  
LACTIC ACID  
MINERAL OIL  
POTASSIUM PHOSPHATE  
WATER  
SILICON DIOXIDE  
SODIUM LAURYL SULFATE  
TITANIUM DIOXIDE  
STARCH, CORN  
Product Characteristics
Color WHITE Score     
Shape Size
Flavor Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:0145-0983-05 1 PACKAGE (BAR) in 1 CARTON
1 113 g in 1 PACKAGE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333D 11/10/2010
Labeler - Stiefel Laboratories Inc (808842343)
Revised: 11/2010
 
Stiefel Laboratories Inc



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