Label: PANOXYL- benzoyl peroxide cream

  • NDC Code(s): 0316-0227-06, 0316-0228-55
  • Packager: Crown Laboratories
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 11, 2021

If you are a consumer or patient please visit this version.

  • 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

    p1153200

  • 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

    p1153300

  • 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
    p1153600

  • 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
    p11537.00

  • INGREDIENTS AND APPEARANCE
    PANOXYL 
    benzoyl peroxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0316-0227
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE58.7 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0316-0227-061 in 1 CARTON12/01/2018
    1170 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D03/25/2011
    PANOXYL 
    benzoyl peroxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0316-0228
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE146.7 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0316-0228-551 in 1 CARTON12/01/2018
    1156 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D03/25/2011
    Labeler - Crown Laboratories (079035945)