Label: PROACTIV RENEWING CLEANSER- benzoyl peroxide cream

  • NDC Code(s): 11410-409-10, 11410-409-20, 11410-409-40, 11410-409-42, view more
    11410-409-70
  • 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 27, 2010

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active Ingredient

    Benzoyl Peroxide 2.5%

    Purpose

    Acne Treatment

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  • Use

    For the management of acne

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  • Warnings

    For external use only

    Ask a doctor or pharmacist before use if you are using other topical acne medications at the same time or immediately following use of this product. This may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

    When using this product

    • avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
    • keep away from lips and mouth.
    • avoid unnecessary sun exposure and use a sunscreen.

    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

    • Use morning and night.
    • Apply a dime-sized amount to damp skin and gently massage for 1 to 2 minutes.
    • Rinse thoroughly with warm water.
    • Pat dry.
    • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
    • If going outside, use a sunscreen.
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  • Other information

    • This product may bleach hair or dyed fabrics.
    • Store at room temperature. Avoid storing at extreme temperatures (below 40°F and above 100°F).
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  • Inactive Ingredients

    water (aqua), magnesium aluminum silicate, glyceryl stearate, PEG-100 stearate, disodium PEG-12 dimethicone sulfosuccinate, sorbitol, dimethyl isosorbide, tridecyl stearate, neopentyl glycol dicaprylate/dicaprate, polyethylene, cetyl esters, anthemis nobilis flower extract, sodium hyaluronate, sodium PCA, xanthan gum, tridecyl trimellitate, propylene glycol, Imidazolidinyl urea, methylparaben, propylparaben, fragrance (parfum)

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  • PRINCIPAL DISPLAY PANEL - 30 mL Label

    Rodan & Fields

    proactiv®
    SOLUTION

    Renewing
    Cleanser

    STEP 1

    benzoyl peroxide acne treatment

    1 FL. OZ. 30 mL

    Principal Display Panel
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  • INGREDIENTS AND APPEARANCE
    PROACTIV RENEWING CLEANSER 
    benzoyl peroxide cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:11410-409
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide 0.25 g  in 1000 mL
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11410-409-40 120 mL in 1 BOTTLE, PLASTIC
    2 NDC:11410-409-20 60 mL in 1 BOTTLE, PLASTIC
    3 NDC:11410-409-10 30 mL in 1 BOTTLE, PLASTIC
    4 NDC:11410-409-70 180 mL in 1 BOTTLE, PLASTIC
    5 NDC:11410-409-42 1 in 1 CARTON
    5 120 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333D 01/01/2009
    Labeler - Guthy-Renker LLC (608315453)
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