Label: BRODA ACNE SPA- salicylic acid gel

  • 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 December 19, 2018

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

  • 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 and rinse thoroughly 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, laureth-4, PEG-400, propylene glycol, glycerine.

  • BRODA Acne Spa Treatment Mask Label

    Tough on acne

    Gentle on your skin

    Anti-acne IntelliGel™

    BRODA Acne Spa Treatment Mask

    IntelliGel™ Technology

    Clears most acne pimples
    Eliminates blackheads and whiteheads
    Prevents acne blemishes

    SUITABLE FOR ALL SKIN TYPES

    Beta Hydroxy Acid
    Hydrogel Spa Treatment

    NET WT. 3.53 oz. (100 g)

    Product Benefits:
    This revolutionary Acne Spa Treatment Mask formula is very effective in reducing blemishes, soothing inflammation, and accelerating skin's clarifying process without irritation even for sensitive skin. Rich in powerful supramolecular beta hydroxy acid complexes, the specially formulated Acne Spa Treatment Mask formula clears up clogged pores, promotes the sloughing away of dead skin cells. After application, skin feels refreshed, moist and relaxed with pores constricting, and your skin will be smoother, suppler and bright with a healthy glow and radiance.

    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.

    Broda_AcneSpa1

    Broda_AcneSpa2

  • INGREDIENTS AND APPEARANCE
    BRODA ACNE SPA 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54111-111
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54111-111-50100 g in 1 TUBE; Type 0: Not a Combination Product10/01/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D10/01/2013
    Labeler - Bentley Laboratories, LLC (068351753)
    Registrant - Bentley Laboratories, LLC (068351753)