Label: ACNE TINTED SPOT TREATMENT- resorcinol, sulfur liquid

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

Drug Label Information

Updated December 17, 2024

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  • Drug Facts

  • Active Ingredients

    Resorcinol 2%

    Sulfur 8%

  • Purpose

    Acne Treatment

  • Use

    For the treatment of acne.

    • Dries and clears acne blemishes and allows skin to heal.
    • Penetrates pores to eliminate most acne blemishes, blackheads, and whiteheads.
    • Helps prevent the development of new acne blemishes, blackheads, and whiteheads.
  • Warnings

    For external use only.

    When using this product

    • apply only to areas with acne
    • rinse right away with water if it gets in eyes
    • 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.

    Stop use and ask a doctor

    • if skin irritation occurs or gets worse

    Keep out of reach of children

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

    Do not use

    on

    • broken skin
    • large areas of the skin
  • Directions

    • Cleanse the skin thoroughly before applying this product.
    • Cover the 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 to 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, PROPYLENE GLYCOL. ALCOHOL DENAT., POLYSORBATE 20, CAPRYLIC/CAPRIC TRIGLYCERIDE, MAGNESIUM ALUMINUM SILICATE, SODIUM STEAROYL, GLUTAMATE, CETEARYL ALCOHOL, GLYCERYL SEARATE, POLYSORBATE 60, CHLOROXYLENOL, ETHYLHEXYLGLYCERIN, FRAGRANCE, PHENOXYETHANOL, POLYGLYCERYL-6 PALMITATE.SUCCINATE, XANTHAN GUM, IRON OXIDES, TITANIUM DIOXIDE

  • Principal Display Panel

    GLYTONE

    ACNE TINTED SPOT TREATMENT

    ACNE THERAPY

    2% RESORCINOL

    8% SULFURE

    30ML / 1 FL. OZ.

    TINTED

  • INGREDIENTS AND APPEARANCE
    ACNE TINTED SPOT TREATMENT 
    resorcinol, sulfur liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84262-023
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR0.08 mg
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.02 mg
    Inactive Ingredients
    Ingredient NameStrength
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    CHLOROXYLENOL (UNII: 0F32U78V2Q)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CETEARYL ALCOHOL (UNII: 2DMT128M1S)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    IRON OXIDES (UNII: 1K09F3G675)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    FARNESOL (UNII: EB41QIU6JL)  
    CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    POLYGLYCERYL-4 PALMITATE (UNII: J6LAJ6FC55)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERYL STEARATE (UNII: 230OU9XXE4)  
    ALCOHOL (UNII: 3K9958V90M)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84262-023-011 in 1 BOTTLE03/01/2024
    130 in 1 CARTON; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00603/01/2024
    Labeler - GLYTONE LLC (119226548)
    Registrant - GLYTONE LLC (119226548)