Label: X OUT SPOT CORRECTOR- sulfur lotion

  • NDC Code(s): 11410-063-11
  • Packager: THE PROACTIV COMPANY 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 January 4, 2013

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Sulfur 6%

  • Purpose

    Acne treatment cream

  • Use

    for the management of acne.

  • Warnings

    For external use only

    When using this product

    • do not use this product more than three times per day.
    • 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.
    • avoid contact with eyes. If contact occurs, rinse thoroughly with water.

    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.

  • Directions

    • 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 stated below.
    • 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.
  • Inactive ingredients

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

  • Questions or comments?

    Within US 1-800-524-7952

  • SPL UNCLASSIFIED SECTION

    Distributed by The Proactive Company LLC ● 100 N Sepulveda Blvd., El Segundo, CA 90245
    Made in the USA of Foreign and Domestic Components ● Xout.com

  • 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

    DT.BOX018_Spot Corrector_1oz_Unit Carton_042517_0 SMALL.jpg
  • INGREDIENTS AND APPEARANCE
    X OUT SPOT CORRECTOR 
    sulfur lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11410-063
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR6 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    ALCOHOL (UNII: 3K9958V90M)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ACACIA (UNII: 5C5403N26O)  
    Olive Oil (UNII: 6UYK2W1W1E)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    .alpha.-tocopherol Acetate (UNII: 9E8X80D2L0)  
    Tea Tree Oil (UNII: VIF565UC2G)  
    Cymbopogon Schoenanthus Top (UNII: 9SJI1LW39W)  
    Geranium Maculatum Root (UNII: 93IXI5B6OJ)  
    Green Tea Leaf (UNII: W2ZU1RY8B0)  
    Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX)  
    Montmorillonite (UNII: A585MN1H2L)  
    Pentylene Glycol (UNII: 50C1307PZG)  
    Ascorbyl Palmitate (UNII: QN83US2B0N)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Avocado Oil (UNII: 6VNO72PFC1)  
    Allantoin (UNII: 344S277G0Z)  
    Acrylic Acid (UNII: J94PBK7X8S)  
    Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) (UNII: 59TL3WG5CO)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Diethylene Glycol Monoethyl Ether (UNII: A1A1I8X02B)  
    Hydroxyphenyl Propamidobenzoic Acid (UNII: 25KRT26H77)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Ethylparaben (UNII: 14255EXE39)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11410-063-111 in 1 BOX09/14/2017
    130 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333D09/14/2017
    Labeler - THE PROACTIV COMPANY LLC (080216357)
    Registrant - VEE PAK, LLC (874763303)
    Establishment
    NameAddressID/FEIBusiness Operations
    VEE PAK, LLC874763303manufacture(11410-063)