Label: DRX BLEMISH CLARIFYING MASK- sulfur lotion

  • NDC Code(s): 58633-704-10
  • Packager: Dr. Dennis Gross Skincare
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 6, 2024

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  • Active Ingredient

    Sulfur 5.0% ...........................................

  • Purpose

    Acne Treatment

  • Uses

    • for the treatment and management of acne
    • penetrates pores to eliminate most acne blemishes and blackheads
    • helps prevent development of new acne blemishes and blackheads
  • Warnings

    For external use only

    When using this product:

    • avoid contact with 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.
    • apply only to areas with acne

    Do not use on:

    • broken skin
    • large areas of the skin

    Keep out of the reach of children. If swallowed, get medical help or contact a Poison 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. Leave on for at least 10 minutes, then rinse.
    • for use as a deeper treatment, apply a thick layer to targeted area as a spot treatment or as an overnight mask. Wash off in the morning.
    • suitable for use on face, chest, and back
    • if bothersome dryness or peeling occurs, reduce application to once a day or every other day
    • 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
  • Inactive Ingredients:

    Water/Aqua/Eau, Kaolin, Cetearyl Alcohol, Glycerin, Butylene Glycol, Polysorbate 20, Acacia Senegal Gum, Zinc Oxide, Bentonite, Carthamus Tinctorius (Safflower) Seed Oil, Farnesol, Opuntia Vulgaris Extract, Salix Alba (Willow) Bark Extract, Bisabolol, Retinol, Phenylethyl Resorcinol, Glycyrrhiza Glabra (Licorice) Root Extract, Tocopherol, Aloe Barbadensis LeafJuice, Tocopheryl Acetate, Glycine Soja (Soybean) Oil, Sodium PCA, Allantoin, Ethylhexylglycerin, Rosmarinus Officinalis (Rosemary) Leaf Oil, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate

  • Questions?

    Call 1-888-830-7546

    Monday through Friday, 9:00 AM to 5:00 PM EST

  • Principal Display Panel – 30 mL Box Label

    Dr Dennis Gross

    DRx Blemish Solutions™

    Clarifying Mask
    with Colloidal Sulfur
    Acne Medication

    You have: Oily skin, acne, breakouts,
    enlarged pores, and
    blackheads

    You want: Balanced, blemish-free,
    clear, and soothed skin

    Net Wt 1.0 oz/30g ℮

    Principal Display Panel – 30 mL Box Label
  • INGREDIENTS AND APPEARANCE
    DRX BLEMISH CLARIFYING MASK 
    sulfur lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58633-704
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sulfur (UNII: 70FD1KFU70) (Sulfur - UNII:70FD1KFU70) Sulfur50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Kaolin (UNII: 24H4NWX5CO)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Glycerin (UNII: PDC6A3C0OX)  
    Polysorbate 60 (UNII: CAL22UVI4M)  
    Acacia (UNII: 5C5403N26O)  
    Zinc Oxide (UNII: SOI2LOH54Z)  
    Bentonite (UNII: A3N5ZCN45C)  
    Safflower Oil (UNII: 65UEH262IS)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Levomenol (UNII: 24WE03BX2T)  
    Allantoin (UNII: 344S277G0Z)  
    Rosemary Oil (UNII: 8LGU7VM393)  
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Phenylethyl Resorcinol (UNII: G37UFG162O)  
    Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Soybean Oil (UNII: 241ATL177A)  
    Opuntia Ficus-Indica Whole (UNII: 23Z87HTQ6P)  
    Farnesol (UNII: EB41QIU6JL)  
    Glycyrrhiza Glabra (UNII: 2788Z9758H)  
    Salix Alba Bark (UNII: 205MXS71H7)  
    Retinol (UNII: G2SH0XKK91)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Potassium Sorbate (UNII: 1VPU26JZZ4)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58633-704-101 in 1 BOX03/01/2020
    130 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00603/01/2020
    Labeler - Dr. Dennis Gross Skincare (008190808)
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