Label: PROACTIV ACNE BODY BAR- salicylic acid soap

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated March 25, 2022

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

  • 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.

    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 thoroughly one to three times daily.
    • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two 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

    sodium palmate, sodium palm kernelate, water, glycerin, sodium gluconate, palm acid, fragrance, sodium chloride, titanium dioxide, bambusa arundinacea stem extract, palm kernel acid, simmondsia chinensis (jojoba) seed oil, camellia sinensis leaf extract, opuntia ficus-indica seed oil

  • 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 - 127 g Bar Carton

    proactiv®

    Acne
    Body Bar

    Salicylic acid
    acne treatment

    Clears up acne blemishes

    Net wt. 4.50 OZ. 127 g


    Carton Label
  • INGREDIENTS AND APPEARANCE
    PROACTIV ACNE BODY BAR 
    salicylic acid soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11410-400
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 mg  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Sodium Palmate (UNII: S0A6004K3Z)  
    Sodium Palm Kernelate (UNII: 6H91L1NXTW)  
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Palm Acid (UNII: B6G0Y5Z616)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Bambusa Bambos Stem (UNII: NRA4497HC5)  
    Palm Kernel Acid (UNII: 79P21R4317)  
    Jojoba Oil (UNII: 724GKU717M)  
    Green Tea Leaf (UNII: W2ZU1RY8B0)  
    Opuntia Ficus-Indica Seed Oil (UNII: 1XGW49AK2J)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Sodium Gluconate (UNII: R6Q3791S76)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11410-400-001 in 1 CARTON06/01/2022
    1127 g in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333D06/01/2022
    Labeler - ALCHEMEE, LLC (080216357)
    Establishment
    NameAddressID/FEIBusiness Operations
    Twincraft Inc093248870manufacture(11410-400)