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PanOxyl

Stiefel Laboratories Inc

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Benzoyl peroxide 3%

Benzoyl peroxide 4%

Benzoyl peroxide 8%

Benzoyl peroxide 10%

Acne medication

For the treatment of acne

For External use only.

Do not use if you

  • •have very sensitive skin
  • •are sensitive to benzoyl peroxide

When using this product

  • •avoid unnecessary sun exposure and use a sunscreen.
  • •avoid contact with the eyes, lips, and mouth.
  • •avoid contact with hair or 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.
  • •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.

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.

  • •clean the skin thoroughly before applying this product
  • •cover the entire affected are with a thin layer 1 to 3 times daily
  • •because excessive 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
  • •wet area to be cleansed.
  • •apply acne wash and gently massage area for 1-2 minutes.
  • •rinse thoroughly and pat dry.
  • •because excessive 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 going outside, use a sunscreen. If irritation or sensitivity develops, discontinue use of both products and consult a doctor.

Store at room temperature

Store at room temperature 59°F to 86°F (15°C to 30°C).

Store at room temperature 59°-86°F (15°-30°C).

Carbomer, dimethicone, disodium EDTA, disodium lauryl sulfosuccinate, glycerin, poloxamer 182, silica, sodium hydroxide, water

cetearyl alcohol, cocamidopropyl betaine, dimethyl isosorbide, glycerin, glycolic acid, hydrogenated castor oil, imidurea, lactic acid, methylparaben, mineral oil, PEG-14M, potassium lauryl sulfate, potassium phosphate, purified water, sodium hydroxide, sodium lauryl sulfate, sodium PCA, titanium dioxide, zea mays (corn) starch.

cetearyl alcohol, cocamidopropyl betaine, dimethyl isosorbide, glycerin, glycolic acid, hydrogenated castor oil, imidurea, lactic acid, methylparaben, mineral oil, PEG-14M, potassium lauryl sulfate, potassium phosphate, purified water, sodium hydroxide, sodium lauryl sulfate, sodium PCA, titanium dioxide, zea mays (corn) starch.

cetearyl alcohol, cocamidopropyl betaine, glycerin, glycolic acid, hydrogenated castor oil, imidurea, lactic acid, methylparaben, mineral oil, PEG-14M, potassium lauryl sulfate, potassium phosphate, purified water, sodium hydroxide, sodium lauryl sulfate, sodium PCA, titanium dioxide, zea mays (corn) starch.

Call 1-888-438-7426.

Stiefel Skin Science Solutions

For over 165 years, Stiefel Laboratories has been committed to advancing dermatology and skin science around the world.

  • •With a superior understanding of the skin and what it needs, Stiefel scientists have developed advanced technologies that help people enjoy healthier more beautiful skin.
  • •Stiefel now brings its skin expertise directly to you through a wide range of skincare products to meet your daily needs

www.panoyxl-skincare.com

PANOXYL is a registered trademark of Stiefel Laboratories, Inc.

Dist.: Stiefel Laboratories, Inc.

Research Triangle Park, NC 27709

Principal Display Panel

NDC 0145-2651-10

PanOxyl®

Benzoyl Peroxide 3%

DERMATOLOGIST RECOMMENDED

ADVANCED ACNE SPOT TREATMENT

  • •Maximum Strength Effectiveness
  • •Kills acne-causing bacteria, while gentle on skin
  • •Helps clear existing acne blemishes

Net wt 0.35 oz (10 g)

©2014 Stiefel Laboratories, Inc.

103913XA

Principal Display Panel

NDC 0145-2660-05

PanOxyl®

Benzoyl Peroxide 4%

DERMATOLOGIST RECOMMENDED

ACNE CREAMY WASH

Daily Control

Daily Cleaning Wash

Face

Chest

Back

  • •Clears existing acne blemishes and helps prevent new blemishes from forming
  • •Quickly penetrates pores killing acne-causing bacteria on contact
  • •Patented Acne Control Formula

Net wt 6.0 oz (170 g)

©2014 Stiefel Laboratories, Inc.

For your protection, do not use if foil seal on tube is broken or missing.

103891XA

Principal Display Panel

NDC 0145-2661-05

PanOxyl®-8

8% Benzoyl Peroxide

ACNE CREAMY WASH

#2 Dermatologist Prescribed Formula

NEW Now Available Without a Prescription!

Patented Acne Control

  • •Patented formula reduces irritation and inflammation
  • Quickly penetrates pores killing the bacteria that cause acne
  • Clears existing acne blemishes and prevents new blemishes from forming

Net Wt 6.0 Oz

(170.1g)

Now you can take control of your acne with a patented formulation formerly available only by prescription.

Panoxyl® 8% Acne Creamy Wash contains Benzoyl Peroxide (BPO), plus a patented delivery system that reduces irritation and inflammation common with conventional BPO acne products.

The thick, creamy formula of Panoxyl® 8% Acne Creamy Wash gently removes dirt and excess oil to clean and unclog pores, making it an excellent choice for the management of acne on the face, chest and back.

©2011 Stiefel Laboratories, Inc.

305323

Principal Display Panel

NDC 0145-0985-05

PanOxyl®

Benzoyl Peroxide 10%

DERMATOLOGIST RECOMMENDED

ACNE FOAMING WASH

Maximum Strength

Deep Cleaning Wash

Face

Chest

Back

  • •Clears existing acne blemishes and helps prevent new blemishes from forming
  • •Quickly penetrates pores killing acne-causing bacteria on contact

Net wt 5.5 oz (156 g)

©2014 Stiefel Laboratories, Inc.

For your protection, do not use if foil seal on tube is broken or missing.

103893XA

PanOxyl

benzoyl peroxide CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0145-2651
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE BENZOYL PEROXIDE 30 mg

Inactive Ingredients

Ingredient Name Strength
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)
DIMETHICONE
EDETATE DISODIUM
DISODIUM LAURYL SULFOSUCCINATE
GLYCERIN
POLOXAMER 182
SILICON DIOXIDE
SODIUM HYDROXIDE
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 10 in 1 TUBE
2 NDC:0145-2651-61 5 in 1 TUBE
3 NDC:0145-2651-63 20 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partD part333D 2014-04-08


PanOxyl

benzoyl peroxide CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0145-2660
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE BENZOYL PEROXIDE 58.7 mg

Inactive Ingredients

Ingredient Name Strength
CETOSTEARYL ALCOHOL
COCAMIDOPROPYL BETAINE
DIMETHYL ISOSORBIDE
GLYCERIN
GLYCOLIC ACID
castor oil
IMIDUREA
LACTIC ACID
METHYLPARABEN
Mineral Oil
POLYETHYLENE GLYCOL 600000
POTASSIUM PHOSPHATE, UNSPECIFIED FORM
water
SODIUM HYDROXIDE
SODIUM LAURYL SULFATE
SODIUM PYRROLIDONE CARBOXYLATE
titanium dioxide
STARCH, CORN

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 170.1 in 1 TUBE
2 NDC:0145-2660-61 5 in 1 TUBE
3 NDC:0145-2660-62 20 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partD part333D 2011-03-25


PanOxyl

benzoyl peroxide CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0145-2661
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE BENZOYL PEROXIDE 117.3 mg

Inactive Ingredients

Ingredient Name Strength
CETOSTEARYL ALCOHOL
COCAMIDOPROPYL BETAINE
DIMETHYL ISOSORBIDE
GLYCERIN
GLYCOLIC ACID
castor oil
IMIDUREA
LACTIC ACID
METHYLPARABEN
Mineral Oil
POLYETHYLENE GLYCOL 600000
POTASSIUM PHOSPHATE, UNSPECIFIED FORM
water
SODIUM HYDROXIDE
SODIUM LAURYL SULFATE
SODIUM PYRROLIDONE CARBOXYLATE
titanium dioxide
STARCH, CORN

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 170.1 in 1 TUBE
2 NDC:0145-2661-05 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partD part333D 2011-03-25


PanOxyl

benzoyl peroxide CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0145-0985
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE BENZOYL PEROXIDE 146.7 mg

Inactive Ingredients

Ingredient Name Strength
CETOSTEARYL ALCOHOL
COCAMIDOPROPYL BETAINE
GLYCERIN
GLYCOLIC ACID
castor oil
IMIDUREA
LACTIC ACID
METHYLPARABEN
Mineral Oil
POLYETHYLENE GLYCOL 600000
POTASSIUM PHOSPHATE, UNSPECIFIED FORM
water
SODIUM HYDROXIDE
SODIUM LAURYL SULFATE
SODIUM PYRROLIDONE CARBOXYLATE
titanium dioxide
STARCH, CORN

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 156 in 1 TUBE
2 NDC:0145-0985-05 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partD part333D 2011-03-25


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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