Label: PROACTIV PLUS RETEXTURIZING TONER- salicylic acid cream

  • NDC Code(s): 11410-051-00, 11410-051-05, 11410-051-10
  • Packager: Alchemee, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 29, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    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 areas 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 use to once a day or every other day.
  • Inactive ingredients

    water, butylene glycol, hamamelis virginiana (witch hazel) water, glycolic acid, sodium hydroxide, phenoxyethanol, polysorbate 20, sodium benzoate, disodium EDTA, ethylhexylglycerin, portulaca oleracea 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.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Proactiv®

    Re-Texturizing
    Toner

    6 FL. OZ. 180 mL

    salicylic acid acne medication 

    Label
  • INGREDIENTS AND APPEARANCE
    PROACTIV PLUS RETEXTURIZING TONER 
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11410-051
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PURSLANE (UNII: M6S840WXG5)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11410-051-001 in 1 CARTON02/15/2014
    159 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:11410-051-051 in 1 CARTON02/15/2014
    259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:11410-051-10180 mL in 1 BOTTLE; Type 0: Not a Combination Product02/15/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00602/15/2014
    Labeler - Alchemee, LLC (080216357)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vee Pak Inc.874763303manufacture(11410-051)
    Establishment
    NameAddressID/FEIBusiness Operations
    kdc/one Chatsworth, Inc.118542196manufacture(11410-051)
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