Label: PROACTIV PLUS COMPLEXION PERFECTING HYDRATOR- salicylic acid lotion

  • NDC Code(s): 11410-010-43, 11410-010-49
  • Packager: Guthy-Renker LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 02/13

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient

    Salicylic Acid 0.5%

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  • Purpose

    Acne Treatment

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  • Use

    for the management of acne.

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  • 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.

    Stop use and ask a doctor

    If irritation becomes severe.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

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  • Directions

    • cleanse 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.
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  • Inactive ingredients

    water (aqua), butylene glycol, cetearyl alcohol, dimethicone, sodium polyacrylate, scutellaria baicalensis root extract, sophora angustifolia root extract, morus alba root extract, glycyrrhiza glabra (licorice) root extract, arctostaphylos uva ursi leaf extract, kojic acid, zinc gluconate, alpha-glucan oligosaccharide, sodium hyaluronate, bisabolol, allantoin, squalane, safflower oil/palm oil aminopropanediol esters, C12-15 alkyl lactate, caprylic/capric triglyceride, caprylyl glycol, ethylhexylglycerin, glycerin, ethylhexyl palmitate, hydrogenated polydecene, hydroxypropyl cyclodextrin, PPG-5 laureth-5, polyquaternium-11, ceteareth-20, aluminum starch octenylsuccinate, polysorbate 60, hexylene glycol, PPG-2 myristyl ether propionate, sodium hydroxide, disodium EDTA, phenoxyethanol, fragrance (parfum)

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  • Questions or comments?

    Within US 1-800-950-4695

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  • SPL UNCLASSIFIED SECTION

    Dist. by: Guthy-Renker® LLC • PO Box 14383
    Palm Desert, CA 92255-4383

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  • PRINCIPAL DISPLAY PANEL - 89 mL Jar Box

    Rodan & Fields
    proactiv+

    Complexion
    Perfecting
    Hydrator

    3 FL. OZ. 89 mL

    salicylic acid
    acne treatment

    Principal Display Panel - 89 mL Jar Box
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  • INGREDIENTS AND APPEARANCE
    PROACTIV PLUS COMPLEXION PERFECTING HYDRATOR 
    salicylic acid lotion
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:11410-010
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
    SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)  
    MORUS ALBA ROOT (UNII: CST1G9BZGD)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36)  
    KOJIC ACID (UNII: 6K23F1TT52)  
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
    .ALPHA.-GLUCAN OLIGOSACCHARIDE (UNII: S95658MI3W)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    ALLANTOIN (UNII: 344S277G0Z)  
    SQUALANE (UNII: GW89575KF9)  
    C12-15 ALKYL LACTATE (UNII: GC844VRD7E)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
    POLYQUATERNIUM-11 (1000000 MW) (UNII: 0B44BS5IJS)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    PPG-2 MYRISTYL ETHER PROPIONATE (UNII: 88R97D8U8A)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11410-010-49 1 in 1 BOX
    1 89 mL in 1 JAR
    2 NDC:11410-010-43 1 in 1 BOX
    2 29.57 mL in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part333D 03/01/2013
    Labeler - Guthy-Renker LLC (608315453)
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