Label: CLARIFYING DETOX MASK WITH GREEN TEA PLUS SULFUR ACNE TREATMENT MASK- sulfur cream

  • 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 19, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Sulfur 3.0%

  • 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.

  • Directions

    • Clean the skin thoroughly before applying this product
    • Cover the entire affected area with a thin layer
    • Leave on for 10-15 minutes, rinse thoroughly, and pat dry
    • Because excessive drying of the skin may occur, start with one application weekly then gradually increase to two or three times weekly if needed or as directed by a doctor
    • If bothersome dryness or peeling occurs, reduce application to once a week or every other week
  • Inactive Ingredients

    Water, Illite, Glycerin, Propanediol, Magnesium Aluminum Silicate, Kaolin, Ethyl Linoleate, Glyceryl Stearate, Cetearyl Alcohol, Ceteareth-20, PEG-100 Stearate, Microcrystalline Wax, Potassium Azeloyl Diglycinate, Morinda Citrifolia Extract, Citrullus Lanatus (Watermelon) Fruit Extract, Menthol, Camellia Sinensis Leaf Extract, Pyrus Malus (Apple) Fruit Extract, Lens Esculenta (Lentil) Fruit Extract, Sodium Lactate, Sodium PCA, Citrus Aurantium Bergamia (Bergamot) Peel Oil, Polyisobutene, Caprylyl/Capryl Glucoside, Sorbitan Oleat, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Caprylyl Glycol, Ethylhexylglycerin, Potassium Chloride, Citric Acid, Disodium EDTA, Xanthan Gum, Chlorphenesin, Potassium Sorbate, Sodium Benzoate, Phenoxyethanol, Chromium Oxide Green

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton

    LANCER™

    CLARIFYING DETOX MASK
    with Green Tea + 3% Sulfur

    Acne Treatment Mask

    1.7 FL.OZ. | 50 mL

    PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton
  • INGREDIENTS AND APPEARANCE
    CLARIFYING DETOX MASK WITH GREEN TEA PLUS SULFUR   ACNE TREATMENT MASK
    sulfur cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72704-105
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sulfur (UNII: 70FD1KFU70) (Sulfur - UNII:70FD1KFU70) Sulfur3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Ledikite (UNII: D7BC5B0F46)  
    Glycerin (UNII: PDC6A3C0OX)  
    Propanediol (UNII: 5965N8W85T)  
    Magnesium Aluminum Silicate (UNII: 6M3P64V0NC)  
    Kaolin (UNII: 24H4NWX5CO)  
    Ethyl Linoleate (UNII: MJ2YTT4J8M)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY)  
    PEG-100 Stearate (UNII: YD01N1999R)  
    Microcrystalline Wax (UNII: XOF597Q3KY)  
    Potassium Azeloyl Diglycinate (UNII: N02RVN6NYP)  
    Morinda Citrifolia Leaf (UNII: 7UOL7P5FF5)  
    Watermelon (UNII: 231473QB6R)  
    Menthol, Unspecified Form (UNII: L7T10EIP3A)  
    Green Tea Leaf (UNII: W2ZU1RY8B0)  
    Apple (UNII: B423VGH5S9)  
    Lens Culinaris Fruit (UNII: ZYZ076G9JH)  
    Sodium Lactate (UNII: TU7HW0W0QT)  
    Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2)  
    Bergamot Oil (UNII: 39W1PKE3JI)  
    Caprylyl/Capryl Oligoglucoside (UNII: E00JL9G9K0)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Potassium Chloride (UNII: 660YQ98I10)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Chlorphenesin (UNII: I670DAL4SZ)  
    Potassium Sorbate (UNII: 1VPU26JZZ4)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Chromic Oxide (UNII: X5Z09SU859)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72704-105-011 in 1 CARTON06/01/2019
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D06/01/2019
    Labeler - Lancer Skincare LLC. (079089155)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vege-Labs117878620MANUFACTURE(72704-105)
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