Label: BPO 8%- benzoyl peroxide gel

  • NDC Code(s): 42192-163-15
  • Packager: Acella Pharmaceuticals LLC
  • 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 7, 2021

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

  • Active Ingredients

    Benzoyl Peroxide 8%

  • Purpose

    Acne Medication

  • Use

    Treats acnes and helps prevent new acne blemishes from forming.

  • Warnings

    For external use only

  • Do not use

    • if you have very sensitive skin or if you are sensitive to benzoyl peroxide.
  • When using this product

    • avoid unnecessary sun exposure and use sunscreen
    • keep away from eyes, lips and mouth
    • avoid contact with hair or dyed fabrics, including carpet and clothing which may be bleached by this product
    • skin irritation may occur, characterized by redness, burning, itching, peeling or possibly swelling. More frequent use or higher concentrations may aggravate such irritation. Mild irritation may be reduced by using the product less frequently or in a lower concentration.
    • 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.
  • 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 application to once a day or every other day
    • If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, discontinue use of product and consult a doctor.
  • Other Information

    Store at controlled room temperature 15˚ - 30˚C (59˚ - 86˚F).

  • Inactive Ingredients

    aloe barbadensis leaf juice, benzyl alcohol, ceteareth-20, cetyl alcohol, dimethyl isosorbide, purified water, simethicone and stearyl alcohol.

  • Questions?

    1-800-541-4802

    Manufactured For:

    Acella Pharmaceuticals, LLC
    Alpharetta, GA 30005

    Rev. 0718-01

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 42192-163-15

    BPO 8% Gel
    (8% benzoyl peroxide acne medication)

    For Topical Use

    Net Wt. 42.5 g (1.5 oz)

    Acella Pharmaceuticals, LLC

    label-figure-01
  • INGREDIENTS AND APPEARANCE
    BPO 8% 
    benzoyl peroxide gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42192-163
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE8 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42192-163-1542500 mg in 1 TUBE; Type 0: Not a Combination Product01/15/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D01/15/2019
    Labeler - Acella Pharmaceuticals LLC (825380939)