Label: SEI BELLA CLARITY CLEAR ACNE ALL-OVER CLEARING SERUM CLEANSING SERUM- salicylic acid soap

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated January 1, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active Ingredient

    Salicylic Acid 2%

  • Purpose

    Acne Treatment

  • INDICATIONS & USAGE

    Use For the treatment and management of acne

  • Warnings

    For external use only Do not get into eyes. If contact occurs, rinse eyes thoroughly with water.

  • WHEN USING

    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 this occurs, only one medication should be used unless otherwise directed by a doctor.

  • STOP USE

    Stop use and ask a doctor ifexcessive irritation of the skin develops.

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Directions

    • Cleanse and tone skin thoroughly before application
    • Cover the entire affected area with a thin layer
    • Use morning and night
    • If excessive drying of the skin occurs, start with one application daily and then gradually increase if needed
    • If bothersome peeling or dryness occurs, reduce application to once a day or every other day
  • INACTIVE INGREDIENT

    1,2 hexanediol, acetamidoethoxyethanol, albatrellus confluens (mushroom) extract, aqua (water/eau), bakuchiol, caprylhydroxamic acid, caprylyl glycol, chlorella vularis (plankton) extract, citric acid, cyclopentasiloxane, dimethicone, ethylhexylglycerin, glycerin, lecithin, lysolecithin, niacinamide, panthenol, PEG/PPG-18/18 dimethicone, phenethyl alcohol, phytic acid, propanediol, pullulan, sclerotium gum, sodium polyacrylate, tocopheryl acetate, tremella fuciformis (silver ear mushroom) sporocarp extract, trideceth-6, trisodium ethylenediamine disuccinate, xanthan gum

  • PRINCIPAL DISPLAY PANEL

    Sei Bella Clarity Clear All-Over Acne Clearing Serum (IFP) label jpg.jpgSei Bella Clarity Clear All-Over Acne Clearing Serum (IFP) drug facts jpg.jpg

  • INGREDIENTS AND APPEARANCE
    SEI BELLA CLARITY CLEAR ACNE ALL-OVER CLEARING SERUM  CLEANSING SERUM
    salicylic acid soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54473-400
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.6 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TREMELLA FUCIFORMIS FRUITING BODY (UNII: GG8N28393G)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    PULLULAN (UNII: 8ZQ0AYU1TT)  
    BAKUCHIOL (UNII: OT12HJU3AR)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    FYTIC ACID (UNII: 7IGF0S7R8I)  
    TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
    WATER (UNII: 059QF0KO0R)  
    BETASIZOFIRAN (UNII: 2X51AD1X3T)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    TRIDECETH-6 (UNII: 3T5PCR2H0C)  
    CHLORELLA VULGARIS (UNII: RYQ4R60M02)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    LYSOPHOSPHATIDYLCHOLINE, SOYBEAN (UNII: CQD833204Z)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    ALBATRELLUS CONFLUENS FRUITING BODY (UNII: 7UVG8A4DP0)  
    SOYBEAN LECITHIN (UNII: 1DI56QDM62)  
    ACETAMIDOETHOXYETHANOL (UNII: LVX2APC4XR)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54473-400-0130 mL in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product01/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00601/01/2024
    Labeler - Melaleuca, Inc. (139760102)
    Establishment
    NameAddressID/FEIBusiness Operations
    Melaleuca, Inc.079711683manufacture(54473-400)