Label: BRODA ACNE- salicylic acid gel

  • NDC Code(s): 54111-112-50, 54111-112-51
  • Packager: Bentley Laboratories, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 18, 2023

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  • Drug Facts Active Ingredient

    Salicylic acid 2%

  • Purpose

    acne treatment

  • Keep out of reach of children

    Keep out of reach of children.

     If swallowed, get medical help or contact a Poison Control Center right away.

  • Uses

    Acne treatment and helps prevent new acne blemishes.

  • Warnings

    For external use only.

  • 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 contact with eyes. If contact occurs, flush thoroughly with water.

  • 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
  • Inactive ingredients

    Water, poloxamer 407, propylene glycol, PEG-400, laureth-4, menthol, bisabolol.

  • BRODA Acne Spot Treatment and Acne Treatment Pen Labels

    Tough on acne

    Gentle on your skin

    Anti-acne IntelliGel™

    BRODA Acne Spot Treatment

    Broda Acne Treatment Pen

    IntelliGel™ Technology
    Suitable for sensitive skin

    Maximum strength with 2% beta hydrox acid
    Forms TrueSkin invisible patch
    No peeling or flaking

    Won't dry your skin

    Alcohol-free Hydrogel

    NET WT. 0.071 oz. (2g) - 0.71 oz. (20 g)

    Distributed by:
    Broda International, LLC
    10 Barley Court
    Plainsboro, NJ 08536
    Manufactured and packaged in the USA
    www.broda.com

    Patent pending

    BRODA™

    Anti-acne IntelliGel™

    Developed with a proprietary break-through IntellGel™ technology that delivers maximum strength acne medication to effectively penetrate pores to clear most acne blemishes and help prevent new acne pimples.

    BrodaAcneSpot1 Label

    Broda AcneSpot2 Label

    Broda AcneSpot3 Label

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  • INGREDIENTS AND APPEARANCE
    BRODA ACNE  
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54111-112
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.4 g  in 20 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    LAURETH-4 (UNII: 6HQ855798J)  
    MENTHOL (UNII: L7T10EIP3A)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54111-112-5020 g in 1 TUBE; Type 0: Not a Combination Product10/29/2013
    2NDC:54111-112-512 g in 1 TUBE; Type 0: Not a Combination Product10/29/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00610/29/2013
    Labeler - Bentley Laboratories, LLC (068351753)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bentley Laboratories, LLC068351753manufacture(54111-112)
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