Label: GAME OVER ACNE DRYING TREATMENT- sulfur cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 9, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Sulfur 10%

  • Purpose

    Acne treatment

  • Uses

    • for the management of acne
    • dries and clears acne blemishes, acne pimples, blackheads, and allows skin to heal
    • helps prevent the development of new acne blemishes, acne pimples and blackheads
  • Warnings

    For external use only.

    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.

    Do not use on

    • broken skin
    • large areas of the skin.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • clean 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
    • Sensitivity Test for a New User: Apply product sparingly to one or two small affected areas during first 3 days. If no discomfort occurs, follow directions above.
  • Inactive ingredients

    Water/Aqua/Eau, Kaolin, Propanediol, Bentonite, Silica, Tetrahexyldecyl Ascorbate, Pentylene Glycol, Butylene Glycol, Phenoxyethanol, Glycerin, Polyacrylate Crosspolymer-6, Ammonium Acryloyldimethyltaurate/VP Copolymer, Sodium Acrylates Copolymer, Dipotassium Glycyrrhizate, Hydrogenated Polyisobutene, Zinc Oxide (CI 77947), Ceramide NP, Citric Acid, Phospholipids, Polyglyceryl-10 Stearate, Sodium Benzotriazolyl Butylphenol Sulfonate, Helianthus Annuus (Sunflower) Seed Oil, Ethylhexylglycerin, Hydroxyphenyl Propamidobenzoic Acid, Tetrasodium Glutamate Diacetate, Terminalia Ferdinandiana Fruit Extract, t-Butyl Alcohol, Podocarpus Elatus Fruit Extract, Pleiogynium Timoriense Fruit Extract, Ascorbyl Palmitate, Sodium Hydroxide, Tocopherol, Sodium Glycolate, Sodium Formate.

  • SPL UNCLASSIFIED SECTION

    Dist. by Offspring Beauty Co.
    West Hollywood, CA 90069

  • PRINCIPAL DISPLAY PANEL - 15 ml Tube Carton

    10% SULFUR
    ACNE TREATMENT

    VERSED

    GAME OVER
    ACNE DRYING TREATMENT

    bentonite + kaolin clay

    0.5 fl. oz. | 15 ml

    Principal Display Panel - 15 ml Tube Carton
  • INGREDIENTS AND APPEARANCE
    GAME OVER ACNE DRYING TREATMENT 
    sulfur cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73690-026
    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)  
    KAOLIN (UNII: 24H4NWX5CO)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    BENTONITE (UNII: A3N5ZCN45C)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    POLYGLYCERYL-10 STEARATE (UNII: 90TF85HH91)  
    SODIUM BENZOTRIAZOLYL BUTYLPHENOL SULFONATE (UNII: 0LA2QC9O3Z)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    KAKADU PLUM (UNII: 0ZQ1D2FDLI)  
    PODOCARPUS ELATUS FRUIT (UNII: R4N1M6CZCY)  
    PLEIOGYNIUM TIMORIENSE FRUIT (UNII: AF3VFG6MLV)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SODIUM GLYCOLATE (UNII: B75E535IMI)  
    SODIUM FORMATE (UNII: 387AD98770)  
    Product Characteristics
    ColorGREEN (Leaf Green) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73690-026-011 in 1 CARTON07/01/2020
    115 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM00607/01/2020
    Labeler - Offspring Beauty Co. (081516405)
    Establishment
    NameAddressID/FEIBusiness Operations
    KDC/One Chatsworth, Inc.118542196MANUFACTURE(73690-026)
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