Label: J9 ULTRA ADVANCED INTENSIVE SCALP SERUM V2- niacinamide liquid

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

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated April 13, 2019

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  • ACTIVE INGREDIENT

    niacinamide

  • INACTIVE INGREDIENT

    WATER
    ALCOHOL
    BENTONITE
    1,2-HEXANEDIOL
    SORBITOL
    WATER
    CARBOMER
    TRIETHANOLAMINE
    FRAGRANCE
    PEG-60 HYDROGENATED CASTOR OIL
    ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER
    DISODIUM EDTA
    PERSEA GRATISSIMA (AVOCADO) OIL
    TOCOPHERYL ACETATE
    WATER
    BUTYLENE GLYCOL
    CHITOSAN SUCCINAMIDE

  • PURPOSE

    enhance you health in scalp and akeep it if you want to be stylish

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    Apply to the scalp and gently rub it to absorb it

  • WARNINGS

    1. when using or after using comsetic products, consult a doctor if you notice any signs of red spots, swelling, or itching symptoms or side effects caused by direct sunlight

    2. do not use in the injured area

    3. precautions during storage and handling

    a) keep out of reach of children

    b) keep out of direct sunlight

    4. if contact with eyes, wash it immediately

  • DOSAGE & ADMINISTRATION

    for topical use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    J9 ULTRA ADVANCED INTENSIVE SCALP SERUM V2 
    niacinamide liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70488-0012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE0.001 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BENTONITE (UNII: A3N5ZCN45C)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70488-0012-120 mL in 1 TUBE; Type 0: Not a Combination Product04/13/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/13/2019
    Labeler - MUSEE Cosmetic Co.,Ltd. (689605445)
    Registrant - MUSEE Cosmetic Co.,Ltd. (689605445)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kolmar Korea Co., Ltd.689512611manufacture(70488-0012)
    Establishment
    NameAddressID/FEIBusiness Operations
    MUSEE Cosmetic Co.,Ltd.689605445label(70488-0012)