Label: VIVANT SULFUR CLAY MASK- sulfur paste

  • NDC Code(s): 63750-006-04
  • Packager: Vivant Pharmaceuticals, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 7, 2024

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  • Active ingredient

    Precipitated Sulfur, 10%

  • Purpose

    Acne Treatment

  • Uses

    Uses ■ Helps clear up acne blemishes, blackheads or whiteheads and allows skin to heal

  • Warnings

    For external use only

    When using this product

    When using this product ■ Do not use on broken skin or apply to large areas of the
    body.

    Stop use and consult a doctor if

    • Rash or irritation develops and last

    Keep out of the reach of children.

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

  • Directions

    Directions
    ■ Cleanse the skin thoroughly before applying medication. Apply a generous layer of the mask to face avoiding the eye area. After fifteen minutes, wash off thoroughly. Follow with the recommended Vivant product. Since 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.

  • Inactive ingredient

    Inactive Ingredients Water, Kaolin, Talc, Bentonite, Magnesium Aluminum Silicate, Saccharomyces/Zinc Ferment, Ethylhexylglycerin, Phenoxyethanol

  • Questions

    1-800-984-8268

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    VIVANT SULFUR CLAY MASK 
    sulfur paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63750-006
    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
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    BENTONITE (UNII: A3N5ZCN45C)  
    KAOLIN (UNII: 24H4NWX5CO)  
    TALC (UNII: 7SEV7J4R1U)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    WATER (UNII: 059QF0KO0R)  
    SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63750-006-04118 mL in 1 JAR; Type 0: Not a Combination Product02/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00602/01/2024
    Labeler - Vivant Pharmaceuticals, LLC (782696814)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vivant Pharmaceuticals, LLC782696814manufacture(63750-006)
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