PANOXYL- benzoyl peroxide soap

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

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 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
• 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

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

• clean the skin thoroughly before applying this product
• work into a lather
• cover the entire affected area with a thin layer and rinse thoroughly one to three times daily
• rinse thoroughly and pat dry
• because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three 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

Aqua, Cetearyl Alcohol, Decyl Glucoside, Dextrin, Glycerin, Sodium Chloride, Sodium Cocoyl Isethionate, Tetrasodium Glutamate
Diacetate

Questions?

call 1-833-279-6522

Panoxyl Acne Treatmet Bar Carton

NEW LOOK

PanOxyl ®

Acne Treatment Bar

for Face & Body

10% BENZOYL PEROXIDE

MAXIMUM STRENGTH

• Clears existing acne and helps prevent new breakouts
• Maximum strength without a prescription

No. 1 DERMATOLOGIST RECOMMENDED BENZOYL PEROXIDE BRAND

Net wt. 4 oz (113 g)

INGREDIENTS AND APPEARANCE

PANOXYL 
benzoyl peroxide soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0316-0264
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	12.6 g  in 113 g

Inactive Ingredients
Ingredient Name	Strength
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
ICODEXTRIN (UNII: 2NX48Z0A9G)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WATER (UNII: 059QF0KO0R)
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0316-0264-04	113 g in 1 CARTON; Type 0: Not a Combination Product	07/01/2023
2	NDC: 0316-0264-01	43 g in 1 CARTON; Type 0: Not a Combination Product	02/23/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	07/01/2023

Labeler - Crown Laboratories (079035945)