Label: MICRONIZED BENZOYL PEROXIDE TREATMENT- benzoyl peroxide gel

  • NDC Code(s): 58400-001-01, 58400-001-02
  • Packager: Pharmco Laboratories Inc.
  • 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 July 10, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Benzoyl Peroxide 2.5%

  • Purpose

    Acne Treatment

  • Uses

    • 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 erduced by using the product less frequently or in a lower concentartion.
    • 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

    • 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 broad spectrum sunscreen SPF 15 or higher.
  • Other Ingredients

    Carbomer, Edetate Disodium, Glycerine, Propylene Glycol, Saccharide Isomerate, Sodium Hydroxide, Water.

  • Other Information

    Store at 15 - 25°C (59 - 77°F) Protect from heat. Keep container tightly closed.

  • SPL UNCLASSIFIED SECTION

    Manufactured by:
    Pharmco Laboratories Inc. • Titusville, FL 32780
    www.pharmcolabs.com • 1.800.635.0712 • Reorder CT07-2

  • PRINCIPAL DISPLAY PANEL - 59 g Tube Label

    PHARMCO
    SKINCARE LABS

    Micronized
    Benzoyl Peroxide
    Treatment Gel
    2.5%

    Net wt. 2 oz. (59 g)

    Principal Display Panel - 59 g Tube Label
  • INGREDIENTS AND APPEARANCE
    MICRONIZED BENZOYL PEROXIDE TREATMENT 
    benzoyl peroxide gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58400-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide25 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Saccharide Isomerate (UNII: W8K377W98I)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58400-001-0159 g in 1 TUBE; Type 0: Not a Combination Product06/01/2012
    2NDC:58400-001-023900 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333D06/01/2012
    Labeler - Pharmco Laboratories Inc. (096270814)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmco Laboratories Inc.096270814MANUFACTURE(58400-001) , LABEL(58400-001) , PACK(58400-001) , ANALYSIS(58400-001)
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