Label: PROACTIV CLEAN ACNE CLEARING HYDRATOR- salicylic acid gel

  • NDC Code(s): 11410-458-00, 11410-458-05, 11410-458-10, 11410-458-15
  • Packager: Alchemee, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 28, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Salicylic Acid 2%

  • Purpose

    Acne treatment

  • Use

    for the management of acne                 

  • 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, rinse eyes thoroughly with water.

    Keep out of reach of children.

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

  • Directions

    • Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below.
    • 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, Glycerin, Glyceryl Stearate SE, Propanediol, Cetyl Phosphate, Cetyl Alcohol, Stearic Acid, Dicaprylyl Carbonate, Undecane, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium Hydroxide, Pentylene Glycol, Cetearyl Alcohol, Tridecane, Bakuchiol, Caprylyl Glycol, Xanthan Gum, Ethylhexylglycerin, Tocopheryl Acetate, Sodium Hyaluronate, Phenoxyethanol, Tocopherol

  • Questions or comments?

    1-800-950-4695

  • SPL UNCLASSIFIED SECTION

    Distributed by
    Alchemee LLC.
    Santa Monica, CA 90401
    Questions or comments?
    1-800-950-4695
    proactiv.com
    Made in the USA of
    foreign and domestic
    components.
    Proactiv is a trademark of
    Taro Pharmaceuticals
    U.S.A., Inc.

  • PRINCIPAL DISPLAY PANEL - 3 FL. OZ. (89 mL)

    proactiv®    

    proactivclean TM

    Acne Clearing
    Hydrator

    3 FL. OZ. (89 mL)

    salicylic acid 
    acne treatment

    unit carton image
  • INGREDIENTS AND APPEARANCE
    PROACTIV CLEAN ACNE CLEARING HYDRATOR 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11410-458
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    CETYL PHOSPHATE (UNII: VT07D6X67O)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    UNDECANE (UNII: JV0QT00NUE)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    TRIDECANE (UNII: A3LZF0L939)  
    BAKUCHIOL (UNII: OT12HJU3AR)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11410-458-001 in 1 BOX02/01/2023
    110 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:11410-458-0530 mL in 1 TUBE; Type 0: Not a Combination Product02/01/2023
    3NDC:11410-458-101 in 1 BOX02/01/2023
    330 mL in 1 TUBE; Type 0: Not a Combination Product
    4NDC:11410-458-151 in 1 BOX02/01/2023
    489 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00602/01/2023
    Labeler - Alchemee, LLC (080216357)
    Establishment
    NameAddressID/FEIBusiness Operations
    kdc/one Chatsworth, Inc.118542196manufacture(11410-458)
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