Label: PANOXYL- benzoyl peroxide cream

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated April 18, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

View All Sections
  • Active ingredient

    Benzoyl peroxide 4%

  • 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

  • Questions or comments?

    call 1-833-279-6522

  • Panoxyl 4% Tube

    NDC 0316-0227-06

    DERMATOLOGIST RECOMMENDED

    PanOxyl®

    ACNE CREAMY WASH

    4% Benzoyl Peroxide

    Daily Control

    Clears Existing Acne and Helps Prevent New Breakouts from Forming

    Treats Acne on Face and Body

    Formulated to be Gentle on Skin

    Net wt. 6oz (170g)

    TAMPER-EVIDENT FEATURE:

    For your protection, do not use if foil seal on tube is broken or missing.

    P11532.03

    PANOXYL is a registered trademark of Crown Laboratories, Inc.

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

    PanOxyl 4pct Wash Tube

  • Panoxyl 4% Carton

    NDC 0316-0227-06

    DERMATOLOGIST RECOMMENDED

    PanOxyl®

    ACNE CREAMY WASH

    4% Benzoyl Peroxide

    Daily Control

    Clears Existing Acne and Helps Prevent New Breakouts from Forming

    Treats Acne on Face and Body

    Formulated to be Gentle on Skin

    Net wt. 6oz (170g)

    PANOXYL is a registered trademark of Crown Laboratories, Inc.

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

    P11730.02

    PanOxyl 4pct Wash Carton

  • 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
    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 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 DrugM00603/25/2011
    Labeler - Crown Laboratories (079035945)
    Establishment
    NameAddressID/FEIBusiness Operations
    Crown Laboratories079035945manufacture(0316-0227)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials

More Info on this Drug

Get Label RSS Feed, View NDC Code(s)NEW!