Label: BENZOYL PEROXIDE CLEANSER- benzoyl peroxide gel

  • NDC Code(s): 58400-009-01, 58400-009-02
  • Packager: Pharmco Laboratories Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 10, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Benzoyl Peroxide 3.5%

  • 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 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

    • Use once or twice daily. Morning and/or night.
    • Apply to damp skin and Wash-In for up to 1 minute.
    • Do not get in the eyes.
    • For best results, use fingertips and apply to affected areas with gentle pressure in a circular motion.
    • Rinse off with warm water and pat dry with soft towel.
    • If going outside, apply broad spectrum sunscreen SPF 15 or higher.
  • Other Ingredients

    Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, C12-14 Alkyl Olefin Sulfonate, Disodium Cocoamphodiacetate, Edetate Disodium, Ethylhexylglycerin, FD&C Yellow # 5, Glycerine, Panthenol, Perlite, Phenoxyethanol, Propylene Glycol, Sodium Hyaluronate, 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

  • PRINCIPAL DISPLAY PANEL - 170 g Bottle Label

    PHARMCO
    SKINCARE LABS

    Benzoyl Peroxide
    Cleansing Gel 3.5%

    Net wt. 6 oz. (170 g)

    PRINCIPAL DISPLAY PANEL - 170 g Bottle Label
  • INGREDIENTS AND APPEARANCE
    BENZOYL PEROXIDE CLEANSER 
    benzoyl peroxide gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58400-009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide35 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    SODIUM C12-14 OLEFIN SULFONATE (UNII: 7I962MCQ71)  
    Disodium Cocoamphodiacetate (UNII: 18L9G3U51M)  
    Glycerin (UNII: PDC6A3C0OX)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    PERLITE (UNII: 0SG101ZGK9)  
    Allantoin (UNII: 344S277G0Z)  
    Panthenol (UNII: WV9CM0O67Z)  
    Hyaluronate Sodium (UNII: YSE9PPT4TH)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    FD&C Yellow NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58400-009-01170 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product12/01/2016
    2NDC:58400-009-023900 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM00612/01/2016
    Labeler - Pharmco Laboratories Inc. (096270814)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmco Laboratories Inc.096270814MANUFACTURE(58400-009) , LABEL(58400-009) , PACK(58400-009) , ANALYSIS(58400-009)
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