Label: PANOXYL- benzoyl peroxide cream
- NDC Code(s): 0316-0228-01, 0316-0228-03, 0316-0228-55
- Packager: Crown Laboratories
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 18, 2024
If you are a consumer or patient please visit this version.
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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
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
- Questions or comments?
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Panoxyl 10% Tube
NDC 0316-0228-55
DERMATOLOGIST RECOMMENDED
PanOxyl®
ACNE FOAMING WASH
10% Benzoyl Peroxide
Maximum Strength
Clears Existing Acne and Helps Prevent New Breakouts from Forming
Treats Acne on Face and Body
Maximum Strength without a Prescription
Net wt. 5.5oz (156g)
TAMPER-EVIDENT FEATURE:
For your protection, do not use if foil seal on tube is broken or missing.
P11536.03
PANOXYL is a registered trademark of Crown Laboratories, Inc.
Distributed by: Crown Laboratories, Inc. Johnson City, TN 37604
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Panoxyl 10% Carton
NDC 0316-0228-55
DERMATOLOGIST RECOMMENDED
PanOxyl®
ACNE FOAMING WASH
10% Benzoyl Peroxide
Acne Treatment Wash
Maximum Strength
Clears Existing Acne and Helps Prevent New Breakouts from Forming
Treats Acne on Face and Body
Maximum Strength without a Prescription
Net wt. 5.5oz (156g)
PANOXYL is a registered trademark of Crown Laboratories, Inc.
Distributed by: Crown Laboratories, Inc. Johnson City, TN 37604
P11731.03
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INGREDIENTS AND APPEARANCE
PANOXYL
benzoyl peroxide creamProduct 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 100 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) 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) 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) SODIUM LAURYLGLUCOSIDES HYDROXYPROPYLSULFONATE (UNII: Z6GFR7R72Y) TERT-BUTYL ALCOHOL (UNII: MD83SFE959) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0316-0228-01 1 in 1 CARTON 10/12/2022 1 28 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:0316-0228-03 85 g in 1 TUBE; Type 0: Not a Combination Product 11/12/2022 3 NDC:0316-0228-55 1 in 1 CARTON 12/01/2018 3 156 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 Drug M006 03/25/2011 Labeler - Crown Laboratories (079035945) Establishment Name Address ID/FEI Business Operations Crown Laboratories 079035945 manufacture(0316-0228)