Label: PROACTIV BLACKHEAD DISSOLVING- salicylic acid gel

  • 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 0.5%

  • 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 uses. 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 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, dimethicone, cyclopentasiloxane, glycereth-26, glycerin, cyclohexasiloxane, PEG-80 sorbitan laurate, dimethiconol, polyacrylate-13, panthenol, phenoxyethanol, fragrance, polyisobutene, caprylyl glycol, aloe barbadensis leaf juice, butyrospermum parkii (shea) butter, hexylene glycol, ethylhexylglycerin, bisabolol, lactic acid, polysorbate 20, ethylhexyl methoxycinnamate, butyl methoxydibenzoylmethane, PPG-26-buteth-26, PEG-40 hydrogenated castor oil, ethylhexyl salicylate, camellia sinensis leaf extract

  • Questions or comments?

    1-800-950-4695

  • SPL UNCLASSIFIED SECTION

    Distributed by Alchemee LLC
    Santa Monica, CA 90401
    Made in the USA of Foreign and
    Domestic Components
    Questions? 1-800-950-4695 • proactiv.com

    Proactiv is a registered trademark of
    Taro Pharmaceuticals U.S.A., Inc.

  • PRINCIPAL DISPLAY PANEL - 30 mL Tube Box

    proactiv®

    BLACKHEAD
    DISSOLVING
    GEL

    1 FL. OZ. 30 mL

    salicylic acid acne medication

    unit carton image
  • INGREDIENTS AND APPEARANCE
    PROACTIV BLACKHEAD DISSOLVING 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11410-024
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    GLYCERETH-26 (UNII: NNE56F2N14)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    DIMETHICONOL (40 CST) (UNII: 343C7U75XW)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    POLYISOBUTYLENE (1300 MW) (UNII: 241BN7J12Y)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)  
    AVOBENZONE (UNII: G63QQF2NOX)  
    OCTINOXATE (UNII: 4Y5P7MUD51)  
    OCTISALATE (UNII: 4X49Y0596W)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYACRYLAMIDE (1300000 MW) (UNII: SC5Y4X78TG)  
    PEG-80 SORBITAN LAURATE (UNII: 239B50Y732)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11410-024-051 in 1 BOX05/01/2013
    130 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00605/01/2013
    Labeler - Alchemee, LLC (080216357)
    Establishment
    NameAddressID/FEIBusiness Operations
    VEE PAK, LLC874763303manufacture(11410-024)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apex International Mfg LLC079110793manufacture(11410-024)
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