Label: PROACTIV ADVANCED DAILY OIL CONTROL- salicylic acid lotion

  • NDC Code(s): 11410-055-00, 11410-055-05
  • Packager: Alchemee, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 28, 2023

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  • 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 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, alcohol denat., butylene glycol, cyclopentasiloxane, nylon-12, glyceryl stearate, PEG-100 stearate, PVM/MA decadiene crosspolymer, aluminum starch octenylsuccinate, cyclohexasiloxane, caprylyl glycol, decylene glycol, phenoxyethanol, sodium hydroxide, hexylene glycol, fragrance, disodium EDTA, pentylene glycol, sebacic acid, 10-hydroxydecanoic acid, 1,10-decanediol, sarcosine, xanthan gum

    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 - 75 mL Carton

     
    proactiv®                     

    ADVANCED
    DAILY
    OIL CONTROL

    2.5 FL. OZ. 75 mL

    salicylic acid acne medication           

    unit carton image
  • INGREDIENTS AND APPEARANCE
    PROACTIV ADVANCED DAILY OIL CONTROL 
    salicylic acid lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11410-055
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.5 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    NYLON-12 (UNII: 446U8J075B)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    DECYLENE GLYCOL (UNII: S57M60MI88)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    10-HYDROXYDECANOIC ACID (UNII: NP03XO416B)  
    SEBACIC ACID (UNII: 97AN39ICTC)  
    1,10-DECANEDIOL (UNII: 5I577UDK52)  
    SARCOSINE (UNII: Z711V88R5F)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11410-055-001 in 1 BOX03/01/2012
    175 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:11410-055-051 in 1 BOX03/01/2012
    222 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00603/01/2012
    Labeler - Alchemee, LLC (080216357)
    Establishment
    NameAddressID/FEIBusiness Operations
    VEE PAK, LLC874763303manufacture(11410-055)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apex International Mfg LLC079110793manufacture(11410-055)
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