Label: PROACTIVPLUS SMOOTHING BHA CLEANSER- salicylic acid liquid

  • NDC Code(s): 11410-216-01, 11410-216-02
  • Packager: Alchemee, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 29, 2024

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.

    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.
    • cover the entire affected area with a thin layer and rinse thoroughlyone 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
    • if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
  • Inactive ingredients

    Water, Cetearyl Alcohol, Glycerin, Cetyl Alcohol, Propanediol, Paraffin, Dimethicone, Glyceryl Stearate, PEG-100 Stearate, Polysorbate 20, Xanthan Gum, Phenoxyethanol, Coco-Glucoside, Glyceryl Oleate, Sodium Hydroxide, Polyacrylate Crosspolymer-6, Ethylhexylglycerin, Citric Acid, Aloe Barbadensis Leaf Juice, t-Butyl Alcohol, Tocopherol, Hydrogenated Palm Glycerides Citrate.

  • Questions or comments?

    1-800-950-4695

  • SPL UNCLASSIFIED SECTION

    Distributed by Alchemee LLC, Hawthorne, NY 10532
    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 - 60 mL Carton

    proactiv+

    Smoothing

    BHA Cleanser
    acne treatment

    1% salicylic acid

    6 FL. OZ. (177.4 mL)

    image 1

  • INGREDIENTS AND APPEARANCE
    PROACTIVPLUS SMOOTHING BHA CLEANSER 
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11410-216
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HYDROGENATED PALM GLYCERIDES CITRATE (UNII: 23AS6RA25L)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    COCO-GLUCOSIDE (UNII: ICS790225B)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    GLYCERYL OLEATE (UNII: 4PC054V79P)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11410-216-011 in 1 BOX03/25/2024
    1177.4 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:11410-216-021 in 1 BOX03/25/2024
    260 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00603/25/2024
    Labeler - Alchemee, LLC (080216357)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vee Pak, LLC dba Voyant Beauty874763303manufacture(11410-216)