KIEHLS SINCE 1851 DERMATOLOGIST SOLUTIONS BREAKOUT CONTROL TARGETED ACNE SPOT TREATMENT (SULFUR) LOTION [L'OREAL USA PRODUCTS INC]

KIEHLS SINCE 1851 DERMATOLOGIST SOLUTIONS BREAKOUT CONTROL TARGETED ACNE SPOT TREATMENT (SULFUR) LOTION [L'OREAL USA PRODUCTS INC]
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NDC 49967-895-01, 49967-895-02
Set ID 217c697e-0260-46d5-a202-ce7345eadd94
Category HUMAN OTC DRUG LABEL
Packager L'Oreal USA Products Inc
Generic Name
Product Class
Product Number
Application Number PART333D
  • Active ingredient


    Sulfur 10%

  • Purpose

    Acne treatment

  • Use

    for the treatment of acne

  • Warnings

    For external use only

  • Do not use on

    • broken skin
    • large areas of the skin
  • When using this product

    • skin irritation and dryness is 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
  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • clean 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 ingredient

    water, niacinamide, zea mays (corn) starch, glycolic acid, stearyl alcohol, glycerin, octyldodecyl myristate, cetearyl alcohol, glyceryl stearate, magnesium aluminum silicate, phenoxyethanol, polyacrylamide, ceteareth-20, sodium hydroxide, PEG-100 stearate, phenylethyl resorcinol, tocopheryl acetate, C13-14 isoparaffin, disodium EDTA, laureth-7, allantoin, aloe barbadensis leaf juice, hydrogenated lecithin, ethylhexylglycerin, glycyrrhiza glabra (licorice) root extract

  • Questions or comments?

    Call toll free 1-800-946-4453

  • PRINCIPAL DISPLAY PANEL

    image of a carton

  • INGREDIENTS AND APPEARANCE
    KIEHLS SINCE 1851 DERMATOLOGIST SOLUTIONS BREAKOUT CONTROL TARGETED ACNE SPOT TREATMENT 
    sulfur lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-895
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENYLETHYL RESORCINOL (UNII: G37UFG162O)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-895-011 in 1 CARTON11/01/2016
    120 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:49967-895-023 mL in 1 PACKET; Type 0: Not a Combination Product11/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D11/01/2016
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    L'Oreal USA, Inc.185931458analysis(49967-895)
    Establishment
    NameAddressID/FEIBusiness Operations
    Englewood Lab, Inc.080987545manufacture(49967-895) , pack(49967-895)

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