Label: PROACTIV REVITALIZING TONER COMBINATION THERAPY ACNE TREATMENT- salicylic acid liquid

  • NDC Code(s): 11410-019-10, 11410-019-20, 11410-019-40, 11410-019-70
  • Packager: Guthy-Renker LLC
  • 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 April 6, 2010

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active Ingredient

    Salicylic Acid 2%

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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

    • using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.
    • avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

    Stop use and ask a doctor if skin irritation occurs.

    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 medication.
    • Using a cotton ball or pad, cover the entire affected area 1 to 3 times daily.
    • Because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 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, hamamelis virginiana (witch hazel) water, glycolic acid, sodium hydroxide, portulaca oleracea extract, polysorbate 20, ethylhexylglycerin, disodium EDTA, phenoxyethanol, sodium benzoate, fragrance (parfum)

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  • PRINCIPAL DISPLAY PANEL - 30 mL Bottle Label

    Rodan & Fields

    proactiv®
    SOLUTION

    2
    REVITALIZING
    TONER

    COMBINATION
    THERAPY®

    salicylic acid acne treatment

    1 FL. OZ. 30 mL

    Principal Display Panel - 30 mL Bottle Label
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  • INGREDIENTS AND APPEARANCE
    PROACTIV REVITALIZING TONER COMBINATION THERAPY ACNE TREATMENT 
    salicylic acid liquid
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:11410-019
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 2 mg  in 100 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11410-019-10 30 mL in 1 BOTTLE
    2 NDC:11410-019-20 60 mL in 1 BOTTLE
    3 NDC:11410-019-40 120 mL in 1 BOTTLE
    4 NDC:11410-019-70 180 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part333D 08/01/2010
    Labeler - Guthy-Renker LLC (608315453)
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