Label: FILLIZER MADHUCA AMPOULE- salicylic acid, tocopheryl acetate, niacinamide liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated November 13, 2020

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  • ACTIVE INGREDIENT

    salicylic acid, tocopheryl acetate, niacinamide

  • PURPOSE

    antiseptic

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF THE CHILDREN

  • INDICATIONS & USAGE

    apply proper amount to the subject area

  • WARNINGS

    ■ For external use only.

    ■ Do not use in eyes.

    ■ lf swallowed, get medical help promptly.

    ■ Stop use, ask doctor lf irritation occurs.

    ■ Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    for external use only

  • INACTIVE INGREDIENT

    Water
    Alcohol
    Polysorbate 80
    Benzyl Glycol
    Ammonium Acryloyldimethyltaurate/VP Copolymer
    Avena Sativa (Oat) Leaf Extract
    Trideceth-10
    Salicylic Acid
    Butylene Glycol
    Madhuca Longifolia Sophorolipids(0.8%)
    Fragrance
    Hydrolyzed Collagen
    Citrus Unshiu Peel Extract
    Dipotassium Glycyrrhizate
    Sodium Citrate
    Ethylhexylglycerin
    Pyridoxine HCl
    1,2-Hexanediol
    Raspberry Ketone
    Menthol
    Althaea Rosea Flower Extract
    Coffea Arabica (Coffee) Seed Extract
    Camellia Sinensis Leaf Extract
    Morus Alba Bark Extract
    Perilla Frutescens Leaf Extract
    Houttuynia Cordata Extract
    Polygonum Multiflorum Root Extract
    Limonene
    Geraniol
    Citronellol
    Butylphenyl Methylpropional
    Linalool
    Alpha-Isomethyl Ionone
    Hydroxycitronellal
    Amyl Cinnamal
    Benzyl Benzoate
    Citral

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    FILLIZER MADHUCA AMPOULE 
    salicylic acid, tocopheryl acetate, niacinamide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81069-0001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL ACETATE2 g  in 100 mL
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.495 g  in 100 mL
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE0.3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81069-0001-17.5 mL in 1 BOTTLE; Type 0: Not a Combination Product11/14/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/14/2020
    Labeler - CJ ENM Co., Ltd. (687982736)
    Registrant - CJ ENM Co., Ltd. (687982736)
    Establishment
    NameAddressID/FEIBusiness Operations
    CJ ENM Co., Ltd.687982736manufacture(81069-0001) , label(81069-0001)
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