Label: J9 ULTRA ADVANCED INTENSIVE SCALP PACK V2- dimethicone cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated April 12, 2019

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  • ACTIVE INGREDIENT

    dimethicone

  • INACTIVE INGREDIENT

    WATER
    BENTONITE
    CETEARYL ALCOHOL
    BEHENYL ALCOHOL
    PROPYLENE GLYCOL
    STEARTRIMONIUM CHLORIDE
    WATER
    BEHENTRIMONIUM CHLORIDE
    ISOPROPYL ALCOHOL
    1,2-HEXANEDIOL
    CYCLOPENTASILOXANE
    FRAGRANCE
    PEG-14M
    PERSEA GRATISSIMA (AVOCADO) OIL
    DISODIUM EDTA
    SODIUM CITRATE
    CITRIC ACID
    PANTHENOL
    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 PACK V2 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70488-0011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BENTONITE (UNII: A3N5ZCN45C)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70488-0011-120 mL in 1 TUBE; Type 0: Not a Combination Product04/13/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34704/13/2019
    Labeler - MUSEE Cosmetic Co.,Ltd. (689605445)
    Registrant - MUSEE Cosmetic Co.,Ltd. (689605445)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kolmar Korea Co., Ltd.689512611manufacture(70488-0011)
    Establishment
    NameAddressID/FEIBusiness Operations
    MUSEE Cosmetic Co.,Ltd.689605445label(70488-0011)
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