P
benzoyl peroxide
Dosage Form: soap
Drug Facts
Active ingredient
Benzoyl peroxide 10%
Purpose
Acne medication
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
NDC Product Code (Source)
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
#
NDC
Package Description
Multilevel Packaging
1
0145-0983-05
1 BAR In 1 CARTON
contains a PACKAGE
1
113 g In 1 PACKAGE
This package is contained within the CARTON (0145-0983-05)
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: 11/2010Stiefel Laboratories Inc
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