Label: PROACTIV PLUS RETEXTURIZING TONER- salicylic acid cream

  • NDC Code(s): 11410-051-00, 11410-051-05, 11410-051-10
  • Packager: THE PROACTIV COMPANY 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 July 10, 2018

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

  • 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

    • do not use this product more than three times per day.
    • skin irritation and dryness are 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.

    Stop use and ask a doctor if

    ▪ irritation becomes severe.

    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.
    • cleanse 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, portulaca oleracea extract, ethylhexylglycerin, polysorbate 20, disodium EDTA, sodium benzoate, phenoxyethanol

  • Questions or comments?

    Within US 1-800-950-4695

  • SPL UNCLASSIFIED SECTION

    Distributed by The Proactiv Company LLC
    100 N Sepulveda Blvd., El Segundo, CA 90245
    proactiv.com ● Made in the USA of Foreign and Domestic Components
    Proactiv is a trademark of The Proactiv Company Sàrl.

  • PRINCIPAL DISPLAY PANEL - 59 mL Carton

    proactiv®

    RE-TEXTURIZING
    TONER
                     

    2 FL. OZ. 59 mL

    salicylic acid acne medication

    Proactiv Retexturizing Toner 59 mL Carton
  • PRINCIPAL DISPLAY PANEL - 59 mL Carton (Pads)

    proactiv®

    Re-Texturizing
    Toner

    2 FL. OZ. 59 mL

    30 Pads

    Proactiv Retexturizing Toner Pads 59 mL Carton
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Proactiv®

    Re-Texturizing
    Toner

    6 FL. OZ. 180 mL

    salicylic acid acne medication 

    Proactiv Retexturizing Toner 180mL Bottle
  • 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 FINALpart333D02/15/2014
    Labeler - THE PROACTIV COMPANY LLC (080216357)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vee Pak Inc.874763303MANUFACTURE(11410-051)