Label: ACNE TREATMENT- benzoyl peroxide gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated August 22, 2024

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

  • Active ingredients

    Benzoyl peroxide 10%

  • Purpose

    Acne medication

  • Use

    for the treatment of acne

  • Warnings

    For external use only

  • Do not use if you

    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 aother 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 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, buring, itching, peeling or posible 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
  • 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
    • cover the entire affected area with a thin layer one to three times daily
    • 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 daily 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
  • Inactive ingredients

    carbomer, disodium EDTA, hydroxypropyl methylcellulose, laureth-4, sodium hydroxide, water

  • Side panel claims

    MEDICATED ACNE GEL

    10% BENZOYL PEROXIDE

    MAXIMUM STRENGTH**

    **MAXIMUM STRENGTH BENZOYL PEROXIDE ACNE MEDICATION AVAILABLE UNDER THE PRODUCT MONOGRAPH

    *THIS PRODUCT IS NOT MANUFACTURED OR DISTRIBUTED BY KENVUE, INC., DISTRIBUTER OF CLEAN & CLEAR ® PERSA-GEL ® 10.

    TIME TO SHINE GUARANTEE

    IF YOU ARE NOT SATISFIED, WE WILL HAPPILY REFUND YOUR MONEY.

  • Claims

    This micronized benzoyl peroxide formula goes to work releasing the medicine deep into the pore where pimples begin.

  • Adverse reaction

    DISTRIBUTED BY:

    RITE AID

    200 NEWBERRY COMMONS

    ETTERS, PA 17319

    www.riteaid.com

  • Principal display panel

    MEDICATED ACNE GEL

    10% BENZOYL PEROXIDE

    MAXIMUM STRENGTH**

    RYSHI ™

    COMPARE TO CLEAN & CLEAR ® PERSA-GEL ® 10*

    NET WT 1 OZ (28 g)

    image description

  • Principal display panel

    daylogic

    10% BENZOYL PEROXIDE

    acne treatment

    MEDICATED GEL

    MAXIMUM STRENGTH

    Maximum Strength Acne Medication Without A Prescription

    DERMATOLOGIST TESTED

    Compare to clean & Clear Persa-Gel 10.*

    NET WT 1 OZ (28 g)

    image description

  • INGREDIENTS AND APPEARANCE
    ACNE TREATMENT 
    benzoyl peroxide gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-7701
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE100 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LAURETH-4 (UNII: 6HQ855798J)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11822-7701-31 in 1 PACKAGE12/02/2011
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00612/02/2011
    Labeler - Rite Aid (014578892)
    Registrant - Consumer Product Partners, LLC (119091520)
    Establishment
    NameAddressID/FEIBusiness Operations
    Consumer Product Partners, LLC119091514manufacture(11822-7701)
    Establishment
    NameAddressID/FEIBusiness Operations
    Remar Inc.117825116pack(11822-7701)