PANOXYL- benzoyl peroxide cream

PanOxyl by

Drug Labeling and Warnings

PanOxyl by is a Otc medication manufactured, distributed, or labeled by Crown Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (4%)

Benzoyl peroxide 4%

Active ingredient (10%)

Benzoyl peroxide 10%

Purpose

Acne medication

Use

• for the treatment of acne

Warnings

For external use only

Do not use if you

• have very sensitive skin
• 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

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• 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 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 20 o - 25 oC (68 o - 77 oF) [see USP Controlled Room Temperature].

Inactive ingredients 4%

carbomer homopolymer type C, carbomer interpolymer type A, decyl glucoside, dimethicone, dioctyl sodium sulfosuccinate, glycerin, palmitic acid, polyacrylate crosspolymer-6, polyoxyl 40 stearate, propanediol, purified water, silica, sodium chloride, sodium citrate, sodium hydroxide, sodium laurylglucosides hydroxypropylsulfonate, sorbitan stearate, sorbitol, stearic acid, t-butyl alcohol, xanthan gum

Inactive ingredients 10%

carbomer homopolymer type C, carbomer interpolymer type A, decyl glucoside, dimethicone, dioctyl sodium sulfosuccinate, glycerin, palmitic acid, polyacrylate crosspolymer-6, polyoxyl 40 stearate, propanediol, purified water, silica, sodium chloride, sodium citrate, sodium hydroxide, sodium laurylglucosides hydroxypropylsulfonate, sorbitan stearate, stearic acid, t-butyl alcohol, xanthan gum

Questions or comments?

call 1-833-279-6522

Panoxyl is a registered trademark of Crown Laboratories, Inc.

©2018 Crown Laboratories, Inc.

Distributed by: Crown Laboratories, Inc., Johnson City, TN 37604

TAMPER-EVIDENT FEATURE: For your protection, do not use if foil seal on tube is broken or missing.

Panoxyl 4% Tube

NDC: 0316-0227-06

DERMATOLOGIST RECOMMENDED

PanOxyl®

ACNE CREAMY WASH

Benzoyl Peroxide 4%

Daily Control

Daily Cleansing Wash

Face

Chest

Back

• Clears existing acne blemishes and helps prevent new blemishes from forming
• Formulated to be gentle on skin
• Contains benzoyl peroxide, an antibacterial ingredient
• Patent Pending Acne Control Formula

Net wt. 6 oz (170 g)

P11532.00

Panoxyl 4% Carton

NDC: 0316-0227-06

DERMATOLOGIST RECOMMENDED

PanOxyl®

ACNE CREAMY WASH

Benzoyl Peroxide 4%

Daily Control

Daily Cleaning Wash

Face

Chest

Back

• Clears existing acne blemishes and helps prevent new blemishes from forming
• Formulated to be gentle on skin
• Contains benzoyl peroxide, an antibacterial ingredient
• Patent Pending Acne Control Formula

Net wt. 6 oz (170 g)

P11533.00

Panoxyl 10% Tube

NDC: 0316-0228-55

DERMATOLOGIST RECOMMENDED

PanOxyl®

ACNE FOAMING WASH

Benzoyl Peroxide 10%

Maximum Strength

Daily Cleansing Wash

Face

Chest

Back

• Clears existing acne blemishes and helps prevent new blemishes from forming
• Formulated to be gentle on skin
• Contains benzoyl peroxide, an antibacterial ingredient
• Patent Pending Acne Control Formula

Net wt. 5.5 oz (156 g)

P11536.00

Panoxyl 10% Carton

NDC: 0316-0228-55

DERMATOLOGIST RECOMMENDED

PanOxyl ®

ACNE FOAMING WASH

Benzoyl Peroxide 10%

Maximum Strength

Deep Cleaning Wash

Face

Chest

Back

• Clears existing acne blemishes and helps prevent new blemishes from forming
• Formulated to be gentle on skin
• Contains benzoyl peroxide, an antibacterial ingredient
• Patent Pending Acne Control Formula

Net wt. 5.5 oz (156 g)

P11537.00

INGREDIENTS AND APPEARANCE

PANOXYL 
benzoyl peroxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0316-0227
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	58.7 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
STEARIC ACID (UNII: 4ELV7Z65AP)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)
PROPANEDIOL (UNII: 5965N8W85T)
XANTHAN GUM (UNII: TTV12P4NEE)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
DIMETHICONE (UNII: 92RU3N3Y1O)
DOCUSATE SODIUM (UNII: F05Q2T2JA0)
PALMITIC ACID (UNII: 2V16EO95H1)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0316-0227-06	1 in 1 CARTON	12/01/2018
1		170 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	03/25/2011

PANOXYL 
benzoyl peroxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0316-0228
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	146.7 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
PALMITIC ACID (UNII: 2V16EO95H1)
DOCUSATE SODIUM (UNII: F05Q2T2JA0)
XANTHAN GUM (UNII: TTV12P4NEE)
WATER (UNII: 059QF0KO0R)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
GLYCERIN (UNII: PDC6A3C0OX)
STEARIC ACID (UNII: 4ELV7Z65AP)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
PROPANEDIOL (UNII: 5965N8W85T)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)
DIMETHICONE (UNII: 92RU3N3Y1O)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0316-0228-55	1 in 1 CARTON	12/01/2018
1		156 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	03/25/2011

Labeler - Crown Laboratories (079035945)