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 December 12, 2024

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

View All Sections
  • 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
    Apex International Mfg LLC079110793manufacture(11410-055)
    Establishment
    NameAddressID/FEIBusiness Operations
    VEE PAK, LLC874763303manufacture(11410-055)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!