Label: PROACTIV REFINING MASK- sulfur cream 

  • Label RSS
  • NDC Code(s): 11410-507-11, 11410-507-17, 11410-507-21, 11410-507-36, view more
    11410-507-66
  • 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 02/14

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredient

    Sulfur 6%

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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.
    • do not get into eyes. If excessive skin irritation develops or increases, discontinue use and consult a doctor.
    • do not use on broken skin or large areas of the skin. Apply only to areas with acne.

    Stop use and ask a doctor if 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

    • for rinse off treatment, apply to dampened skin.
    • leave on for 10 minutes.
    • rinse with water.
    • for leave on treatment, apply to affected area.
    • leave on overnight.
    • rinse off in the morning.
    • use 2-3 times a week.
    • if going outside, use a sunscreen.
    • if bothersome dryness or peeling occurs, reduce application use.
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  • Inactive ingredients

    water (aqua), kaolin, glycereth-26, linoleic acid, cetearyl alcohol, magnesium aluminum silicate, zinc oxide, ceteareth-20, sodium lauroyl sarcosinate, linolenic acid, cymbopogon schoenanthus extract, geranium maculatum extract, melaleuca alternifolia (tea tree) leaf oil, tocopherol, tocopheryl acetate, butylene glycol, hydrated silica, ethoxydiglycol, ethylparaben, methylparaben, fragrance (parfum), titanium dioxide (CI 77891)

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  • SPL UNCLASSIFIED SECTION

    Dist. by Guthy-Renker®
    PO Box 14383, Palm Desert, CA 92255-4383
    proactiv.com

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  • PRINCIPAL DISPLAY PANEL - 70 g Tube Label

    Rodan & Fields

    proactiv®
    SOLUTION

    REFINING
    MASK

    deep cleans

    helps to minimize the
    appearance of pores

    sulfur acne treatment

    2.5 OZ. 70 g

    Principal Display Panel - 70 g Tube Label
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  • INGREDIENTS AND APPEARANCE
    PROACTIV REFINING MASK 
    sulfur cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:11410-507
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Sulfur (Sulfur) Sulfur 0.06 g  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    KAOLIN  
    LINOLEIC ACID  
    CETOSTEARYL ALCOHOL  
    MAGNESIUM ALUMINUM SILICATE  
    ZINC OXIDE  
    POLYOXYL 20 CETOSTEARYL ETHER  
    SODIUM LAUROYL SARCOSINATE  
    LINOLENIC ACID  
    TEA TREE OIL  
    .ALPHA.-TOCOPHEROL  
    .ALPHA.-TOCOPHEROL ACETATE, DL-  
    BUTYLENE GLYCOL  
    HYDRATED SILICA  
    DIETHYLENE GLYCOL MONOETHYL ETHER  
    ETHYLPARABEN  
    METHYLPARABEN  
    TITANIUM DIOXIDE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11410-507-11 1 in 1 BOX
    1 28 g in 1 TUBE
    2 NDC:11410-507-17 48 g in 1 TUBE
    3 NDC:11410-507-21 1 in 1 BOX
    3 70 g in 1 TUBE
    4 NDC:11410-507-36 100 g in 1 TUBE
    5 NDC:11410-507-66 1 in 1 BOX
    5 NDC:11410-507-36 100 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part333D 12/01/1998
    Labeler - Guthy-Renker LLC (608315453)
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