Label: X OUT SPOT CORRECTOR- sulfur lotion 

  • 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 01/13

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

    • 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.
    • apply only to areas with acne.

    Do not use on

    • broken skin
    • large areas of the skin

    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

    • apply a small amount to dampened skin.
    • cover the entire affected area with a thin layer and rinse thoroughly 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.
    • Sensitivity Test for a New User: Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions above.
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  • Inactive ingredients

    water, dicaprylyl carbonate, montmorillonite, alcohol denat., neopentyl glycol diheptanoate, glycerine, acacia senegal gum, triethanolamine, olive oil PEG-7 esters, butylene glycol, ethoxydiglycol, camellia sinensis leaf extract, cymbopogon schoenanthus extract, geranium maculatum extract, melaleuca alternifolia (tea tree) leaf oil, dipotassium glycyrrhizate, hydroxyphenyl propamidobenzoic acid, tocopheryl acetate, allantoin, pentylene glycol, ethylhexylglycerin, butyl oleate, glyceryl acrylate/acrylic acid copolymer, acrylates/C10-30 alkyl acrylate crosspolymer, disodium EDTA, butylparaben, ethylparaben, isobutylparaben, methylparaben, phenoxyethanol, propylparaben, fragrance

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  • Questions or comments?

    Within US 1-800-524-7952

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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 - 30 mL Tube Carton

    X®
    OUT

    SPOT CORRECTOR

    From the Makers of Proactiv®

    sulfur acne treatment
    1.0 FL. OZ. • 30 mL

    Principal Display Panel - 30 mL Tube Carton
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  • INGREDIENTS AND APPEARANCE
    X OUT SPOT CORRECTOR 
    sulfur lotion
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:11410-006
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SULFUR (SULFUR) SULFUR 6 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    DICAPRYLYL CARBONATE  
    MONTMORILLONITE  
    ALCOHOL  
    NEOPENTYL GLYCOL DIHEPTANOATE  
    GLYCERIN  
    ACACIA  
    TROLAMINE  
    BUTYLENE GLYCOL  
    DIETHYLENE GLYCOL MONOETHYL ETHER  
    GREEN TEA LEAF  
    CYMBOPOGON SCHOENANTHUS TOP  
    GERANIUM MACULATUM ROOT  
    TEA TREE OIL  
    GLYCYRRHIZINATE DIPOTASSIUM  
    HYDROXYPHENYL PROPAMIDOBENZOIC ACID  
    .ALPHA.-TOCOPHEROL ACETATE  
    ALLANTOIN  
    PENTYLENE GLYCOL  
    ETHYLHEXYLGLYCERIN  
    BUTYL OLEATE  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)  
    EDETATE DISODIUM  
    BUTYLPARABEN  
    ETHYLPARABEN  
    ISOBUTYLPARABEN  
    METHYLPARABEN  
    PHENOXYETHANOL  
    PROPYLPARABEN  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:11410-006-11 1 in 1 BOX
    1 30 mL in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part333D 12/31/2012
    Labeler - Guthy-Renker LLC (608315453)
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