Label: MICRONIZED BPO SCRUB- benzoyl peroxide gel

  • 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 February 9, 2015

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


    Drug Facts

  • Active Ingredient

    Benzoyl Peroxide 5%

  • Purpose

    Acne Treatment

  • 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.
    • If going outside, apply sunscreen after using this product.

    • If sensitivity develops or irritation becomes severe, stop use and ask a doctor.

    • Keep out of reach of children

    • If swallowed get medical help or call a poison control center immediately.
    • Keep away from excessive heat or heat sources
  • Directions

    Apply a quarter-sized amount to damp skin with gentle pressure and work into lather. Rinse with lukewarm water and pat dry with soft towel. Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two to three times daily or as directed by a physician or skincare professional. If bothersome dryness or peeling occurs, reduce frequency of applications. If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use and consult a physician or skin care professional.

  • Other Ingredients

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, C12-14 Alkyl Olefin Sulfonate, Disodium Cocoamphodiacetate, Edetate Disodium, Ethylhexylglycerin, Glycerin, Panthenol, Phenoxyethanol, Polyethylene, Propylene Glycol, Sodium Hyaluronate, Sodium Hydroxide.

  • Other Information

    Store at 20 - 25°C (68 - 77°F) Protect from heat. Keep container tightly closed.


    Manufactured by:
    Pharmco Laboratories Inc. • Titusville, FL 32780 • 1.800.635.0712 • Reorder CPL03-8

  • PRINCIPAL DISPLAY PANEL - 240 g Bottle Label


    BPO 5%

    Net wt. 8 oz. (240 g)

    PRINCIPAL DISPLAY PANEL - 240 g Bottle Label
    benzoyl peroxide gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58400-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Disodium Cocoamphodiacetate (UNII: 18L9G3U51M)  
    Allantoin (UNII: 344S277G0Z)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Panthenol (UNII: WV9CM0O67Z)  
    Hyaluronate Sodium (UNII: YSE9PPT4TH)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    High Density Polyethylene (UNII: UG00KM4WR7)  
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58400-005-01240 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
    2NDC:58400-005-023900 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333D06/01/2012
    Labeler - Pharmco Laboratories Inc. (096270814)
    NameAddressID/FEIBusiness Operations
    Pharmco Laboratories Inc.096270814MANUFACTURE(58400-005) , LABEL(58400-005) , PACK(58400-005) , ANALYSIS(58400-005)