Label: BPO 6%- benzoyl peroxide cloth

  • NDC Code(s): 42192-161-60
  • 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 June 4, 2018

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

  • SPL UNCLASSIFIED SECTION

    6% Benzoyl Peroxide Acne Medication

    Drug Facts

  • Active ingredients

    Benzoyl Peroxide 6%

  • Purpose

    Acne Medication

  • Use

    treats acne and helps prevent new acne blemishes from forming.

  • Warnings

    For external use only

    Do not use

    •  if you have very sensitive skin 
    •  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

    • wash the affected area once or twice daily
    • wet face with water
    • wet cloth with a little water and work into a full lather
    • cleanse face with cloth for 10 - 20 seconds, avoiding eyes and mucous membranes.
    • rinse thoroughly and pat dry
    • discard cloth, do not flush
    • If drying occurs, it may be controlled by rinsing cleanser off sooner or using less often
    • If going outside, use a sunscreen. If irritation or sensitivity develops, discontinue use of both products and consult a doctor.
  • Other Information

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

  • Inactive Ingredients

    cetostearyl alcohol, cocamidopropyl betaine, corn starch, deionized water, dimethyl isosorbide, glycerine, glycolic acid, hydrogenated castor oil, imidurea, methylparaben, mineral oil, PEG-14M, potassium chloride, sodium hydroxide, sodium lauryl sulfate, sodium PCA and titanium dioxide.

    Questions? 1-800-541-4802

    Manufactured by:
    Acella Pharmaceuticals, LLC
    1-800-541-4802
    Rev 1017-02

  • PRINCIPAL DISPLAY PANEL

    NDC 42192-161-60

    BPO 6% Foaming Cloths

    6% Benzoyl Peroxide
    Acne Medication

    Net weight 3.2 g

    Acella PHARMACEUTICALS, LLC

    PRINCIPAL DISPLAY PANEL - label

    NDC 42192-161-60

    BPO 6% Foaming Cloths

    6% Benzoyl Peroxide
    Acne Medication

    60 foaming cloths • Net weight 3.2 g each

    Acella PHARMACEUTICALS, LLC

    PRINCIPAL DISPLAY PANEL - 60 Cloth Packet Carton
  • INGREDIENTS AND APPEARANCE
    BPO 6% 
    benzoyl peroxide cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42192-161
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE60 mg
    Inactive Ingredients
    Ingredient NameStrength
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    WATER (UNII: 059QF0KO0R)  
    DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    IMIDUREA (UNII: M629807ATL)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYETHYLENE OXIDE 600000 (UNII: 2126FD486L)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42192-161-6060 in 1 CARTON06/01/2018
    11 in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333D06/01/2018
    Labeler - Acella Pharmaceuticals, LLC (825380939)
    Establishment
    NameAddressID/FEIBusiness Operations
    Acella Pharmaceuticals, LLC825380939MANUFACTURE(42192-161)