Label: PROACTIV CLARIFYING NIGHT- salicylic acid cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 28, 2023

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Salicylic Acid 1%

  • 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, ethylhexyl palmitate, cetearyl alcohol, cyclopentasiloxane, PPG-12/SMDI copolymer, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, squalane, hexylene glycol, phenoxyethanol, dicetyl phosphate, ceteth-10 phosphate, glyceryl stearate, PEG-100 stearate, dimethicone, fragrance, polysorbate 60, sodium hydroxide, methylparaben, aleurites moluccanus seed oil, retinyl palmitate, panthenol, propylparaben, ethylparaben, butylene glycol, chamomilla recutita (matricaria) flower extract, caprylic/capric triglyceride, tocopherol, sodium hyaluronate, sodium ascorbate, retinol

  • 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 - 2.5 FL. OZ. (75 mL) 

    proactiv®    

    CLARIFYING
    NIGHT
    CREAM

    2.5 FL. OZ. (75 mL)

    salicylic acid acne medication

    unit carton image
  • INGREDIENTS AND APPEARANCE
    PROACTIV CLARIFYING NIGHT 
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11410-030
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PPG-12/SMDI COPOLYMER (UNII: 1BK9DDD24E)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    SQUALANE (UNII: GW89575KF9)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
    CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)  
    CHAMOMILE (UNII: FGL3685T2X)  
    KUKUI NUT OIL (UNII: TP11QR7B8R)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    RETINOL (UNII: G2SH0XKK91)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SODIUM ASCORBATE (UNII: S033EH8359)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11410-030-001 in 1 BOX06/01/2015
    175 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00606/01/2015
    Labeler - Alchemee, LLC (080216357)
    Establishment
    NameAddressID/FEIBusiness Operations
    VEE PAK, LLC874763303manufacture(11410-030)