Label: DR DENNIS GROSS ALL-OVER BLEMISH- salicylic acid gel

  • NDC Code(s): 54111-124-50
  • Packager: Bentley Laboratories, LLC
  • 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 2.0%

  • 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

    • for the treatment and management of acne
    • penetrates pores to eliminate most acne blemishes and blackheads
    • helps prevent development of new acne blemishes and blackheads
  • Warnings

    For external use only.

  • When using this product

    • using other topical acne drugs at the same time or right after use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.
  • Directions

    • cleanse skin thoroughly before applying
    • cover the entire affected area AM or PM
    • if bothersome dryness or peeling occurs, reduce application to every other day.
  • Inactive ingredients

    Cyclopentasiloxane, Dimethicone Crosspolymer, Dimethicone/Vinyltrimethylsiloxysilicate Crosspolymer, Squalane, Dimethicone/Vinyl Dimethicone Crosspolymer, Ubiquinone, Disodium EDTA, Bisabolol, Menthol, Phenoxyethanol, Farnesol

  • dr.dennis gross All-Over Blemish Product Label

    dr.dennisgross™
    SKINCARE

    All-Over
    Blemish
    Solution

    Salicylic Acid
    Acne Treatment Gel

    Pore Minimizer for Sensitive Skin

    DERMATOLOGIST APPROVED HYPOALLERGENIC

    1.7 fl oz/50mL e

    Eliminates and prevents blackheads
    Controls oil and shine
    Non-drying for sensitive, acne-prone skin

    PARABEN FREE

    Dr. Dennis Gross Skincare™  LLC.,
    Dist. NY, NY 10022
    dgskincare.com
    MD031521

    VEGAN


    Bently drgrossAllBlemish1 Label

    Bentley drgrossAllBlemish Label



  • INGREDIENTS AND APPEARANCE
    DR DENNIS GROSS ALL-OVER BLEMISH  
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54111-124
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONE PEG-7 PHOSPHATE (UNII: WTP86Y84TV)  
    CYCLOMETHICONE 4 (UNII: CZ227117JE)  
    SQUALANE (UNII: GW89575KF9)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    UBIDECARENONE (UNII: EJ27X76M46)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    FARNESOL (UNII: EB41QIU6JL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54111-124-5050 mL in 1 TUBE; Type 0: Not a Combination Product11/01/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D11/01/2009
    Labeler - Bentley Laboratories, LLC (068351753)
    Registrant - Bentley Laboratories, LLC (068351753)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bentley Laboratories, LLC068351753manufacture(54111-124)