Label: CLARIFYING SPOT WITH SULFUR PLUS GREEN CLAY ACNE MEDICATION- sulfur solution

  • 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 September 29, 2021

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Sulfur 10.0%

  • Purpose

    Acne Treatment

  • Uses

    For the management 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 product is swallowed, get medical help or contact a poison control center right away.

    Flammable, keep away from fire or flame.

  • 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 Ingredients

    Alcohol Denat., Water, Azelaic Acid, PVP, Camellia Sinensis Leaf Extract, Salicylic Acid, Papain, Bromelain, Maltodextrin, Glycerin, Magnesium Aluminum Silicate, Disodium Carboxyethyl Siliconate, Illite, Montmorillonite, Kaolin, Calcite, Sodium Hydroxide, Chromium Oxide Greens, Titanium Dioxide

  • Questions?

    1800-899-0744 M-F 9-5PST

  • SPL UNCLASSIFIED SECTION

    Dist. by
    LANCER SKINCARE LLC
    440 N. Rodeo Dr., 3F
    Beverly Hills, CA 90210

  • PRINCIPAL DISPLAY PANEL - 9 mL Tube Carton

    LANCER®

    RESEARCHED
    AND DEVELOPED
    AT
    LANCERX
    dermatology
    BEVERLY HILLS

    • UTMOST LUXURY
    • LANCER SKINCARE
    • FIRST-CLASS DERMATOLOGY
    • TRUE EFFICACY

    CLARIFYING SPOT
    SOLUTION
    with 10% Sulfur + Green Clay

    0.3 FL.OZ. | 9 mL

    PRINCIPAL DISPLAY PANEL - 9 mL Tube Carton
  • INGREDIENTS AND APPEARANCE
    CLARIFYING SPOT WITH SULFUR PLUS GREEN CLAY   ACNE MEDICATION
    sulfur solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72704-129
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sulfur (UNII: 70FD1KFU70) (Sulfur - UNII:70FD1KFU70) Sulfur10 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Alcohol (UNII: 3K9958V90M)  
    Water (UNII: 059QF0KO0R)  
    Azelaic Acid (UNII: F2VW3D43YT)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    Green Tea Leaf (UNII: W2ZU1RY8B0)  
    Salicylic Acid (UNII: O414PZ4LPZ)  
    Papain (UNII: A236A06Y32)  
    Bromelains (UNII: U182GP2CF3)  
    Maltodextrin (UNII: 7CVR7L4A2D)  
    Glycerin (UNII: PDC6A3C0OX)  
    Magnesium Aluminum Silicate (UNII: 6M3P64V0NC)  
    Disodium Carboxyethyl Siliconate (UNII: 4U4C79679G)  
    Ledikite (UNII: D7BC5B0F46)  
    Montmorillonite (UNII: A585MN1H2L)  
    Kaolin (UNII: 24H4NWX5CO)  
    Calcium Carbonate (UNII: H0G9379FGK)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Chromic Oxide (UNII: X5Z09SU859)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72704-129-011 in 1 CARTON10/15/2021
    19 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333D10/15/2021
    Labeler - Lancer Skincare LLC. (079089155)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vege-Labs117878620MANUFACTURE(72704-129)