Label: PROACTIV DEEP CLEANSING WASH- salicylic acid lotion/shampoo

  • NDC Code(s): 11410-048-00, 11410-048-05, 11410-048-10, 11410-048-15, view more
    11410-048-20
  • Packager: THE PROACTIV COMPANY LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 4, 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 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 ifirritation 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.
    • apply a small amount to dampened skin.
    • cover the entire affected area with a thin layer and rinse thoroughly.  Shake before use.
    • because excessive drying of the skin may occur, start with one application every other day, then gradually increase to one application daily or as directed by a doctor.
    • if bothersome dryness or peeling occurs, reduce application use to every other day.
  • Inactive Ingredients

    Water, Cocamidopropyl Betaine, Distearyl Phthalic Acid Amide, Paraffin, Stearyl Alcohol, Cetyl Alcohol, Jojoba Esters, Sodium Chloride, Sodium Methyl Cocoyl Taurate, Aloe Barbadensis Leaf Juice, Camellia Sinensis Leaf Extract, Coconut Acid, Menthol, PEG-120 Methyl Glucose Dioleate, Caprylyl Glycol, Hexylene Glycol, Ethylhexylglycerin, Ascorbic Acid, Citric Acid, Butylene Glycol, Disodium EDTA, Isopropyl Alcohol, Sodium Hydroxide, Phenoxyethanol, Sodium Benzoate, Sodium Sulfite, Potassium Sorbate, Fragrance, Chromium Hydroxide Green

    Questions or comments?
    Within US 1-800-950-4695

  • PRINCIPAL DISPLAY PANEL - 89 mL Carton

    proactiv ®

    DEEP
    CLEANSING
    WASH

    3 FL. OZ. 89 mL

    salicylic acid acne treatment

    Dist. 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.

    Proactiv Deep Cleansing Wash 89 mL Carton
  • PRINCIPAL DISPLAY PANEL - 267 mL Tube

    proactiv ®

    DEEP
    CLEANSING
    WASH

    9 FL. OZ. 267 mL

    salicylic acid acne medication

    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.

    Proactiv Deep Cleansing Wash 267 mL
  • PRINCIPAL DISPLAY PANEL - 475 mL Tube

    proactiv ®

    DEEP
    CLEANSING
    WASH

    16 FL. OZ. 475 mL

    salicylic acid acne medication

    Proactiv Deep Cleansing Wash 475 mL Tube
  • INGREDIENTS AND APPEARANCE
    PROACTIV DEEP CLEANSING WASH 
    salicylic acid lotion/shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11410-048
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    DISTEARYL PHTHALAMIC ACID (UNII: 5552GSZ9LI)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    COCONUT ACID (UNII: 40U37V505D)  
    MENTHOL (UNII: L7T10EIP3A)  
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM SULFITE (UNII: VTK01UQK3G)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    CHROMIUM HYDROXIDE GREEN (UNII: RV8FT8XF5R)  
    HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11410-048-051 in 1 CARTON10/01/2010
    189 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:11410-048-10267 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/01/2010
    3NDC:11410-048-15475 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/01/2010
    4NDC:11410-048-00720 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/01/201004/30/2019
    5NDC:11410-048-201 in 1 CARTON03/01/2019
    510 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00610/01/2010
    Labeler - THE PROACTIV COMPANY LLC (080216357)
    Establishment
    NameAddressID/FEIBusiness Operations
    VEE PAK, LLC874763303manufacture(11410-048)
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