Label: PANOXYL- benzoyl peroxide cream
- NDC Code(s): 0316-0227-06, 0316-0227-10
- Packager: Crown Laboratories
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 12, 2026
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- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Use
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Warnings
For external use only
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.
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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
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Inactive ingredients (4%)
Aqua, Carbomer, Decyl Glucoside, Diethylhexyl Sodium Sulfosuccinate, Dimethicone, Glycerin, Oleic Acid, Palmitic Acid, PEG-40 Stearate, Polyacrylate Crosspolymer-6, Propanediol, Silica, Sodium Chloride, Sodium Citrate, Sodium Hydroxide, Sodium Laurylglucosides Hydroxypropylsulfonate, Sorbitan Stearate, Sorbitol, Stearic Acid, t-Butyl alcohol, Xanthan Gum
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- Panoxyl 4% Tube
- Panoxyl 4% Carton
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INGREDIENTS AND APPEARANCE
PANOXYL
benzoyl peroxide creamProduct 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 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) SODIUM CHLORIDE (UNII: 451W47IQ8X) TERT-BUTYL ALCOHOL (UNII: MD83SFE959) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) WATER (UNII: 059QF0KO0R) AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9) 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) 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 2 NDC:0316-0227-10 1 in 1 CARTON 12/31/2035 2 85 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 Drug M006 03/25/2011 Labeler - Crown Laboratories (119508400) Establishment Name Address ID/FEI Business Operations Crown Laboratories 119508400 manufacture(0316-0227)


