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 LABEL Item Code (Source) NDC:11410-010
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    BUTYLENE GLYCOL  
    CETOSTEARYL ALCOHOL  
    DIMETHICONE  
    SODIUM POLYACRYLATE (8000 MW)  
    SCUTELLARIA BAICALENSIS ROOT  
    SOPHORA FLAVESCENS ROOT  
    MORUS ALBA ROOT  
    GLYCYRRHIZA GLABRA  
    ARCTOSTAPHYLOS UVA-URSI LEAF  
    KOJIC ACID  
    ZINC GLUCONATE  
    .ALPHA.-GLUCAN OLIGOSACCHARIDE  
    HYALURONATE SODIUM  
    LEVOMENOL  
    ALLANTOIN  
    SQUALANE  
    C12-15 ALKYL LACTATE  
    MEDIUM-CHAIN TRIGLYCERIDES  
    CAPRYLYL GLYCOL  
    ETHYLHEXYLGLYCERIN  
    GLYCERIN  
    ETHYLHEXYL PALMITATE  
    HYDROGENATED POLYDECENE (550 MW)  
    POLYQUATERNIUM-11 (1000000 MW)  
    POLYOXYL 20 CETOSTEARYL ETHER  
    ALUMINUM STARCH OCTENYLSUCCINATE  
    POLYSORBATE 60  
    HEXYLENE GLYCOL  
    PPG-2 MYRISTYL ETHER PROPIONATE  
    SODIUM HYDROXIDE  
    EDETATE DISODIUM  
    PHENOXYETHANOL  
    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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