Label: DONG SUNG MONELYN- zinc pyrithione suspension, panthenol, niacinamide, biotin shampoo

  • 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 June 14, 2016

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  • ACTIVE INGREDIENT

    Zinc Pyrithione Suspension (50%) 2.10%, Panthenol 0.50%, Niacinamide 0.30%, Biotin 0.06%

  • INACTIVE INGREDIENT

    Sodium Polyoxyethylene Laurylether Sulfate, Ammonium Lauryl Sulfate Solution Cocamidopropylbetaine, Cocamide DEA, Dimethicone, Polyquaternium-7, Carbomers, Jojoba Oil, Disodium Edetate Hydrate, Guar Hydroxypropyltrimonium Chloride Sage Extract, Rosemary Extract, Lily Extract, Chamomile Extract, Saffron Extract,Ginseng Extract, Green Tea Extract, Sophora Extract, Paeonia Extract, Loquat Leaf Extract, Water

  • PURPOSE

    Uses To recover the scalp condition for healthier hair. To strengthen hair root, give growth stimulation and thicken hair.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out or reach of the children

  • INDICATIONS & USAGE

    Wet hair and scalp thoroughly, apply the adequate amount on scalp. Gently massage moisten hair and scalp for 2-3 minutes. Lather and wash with tepid water.

  • WARNINGS

    For external use only
    Do not use when Your scalp is red, inflamed, irritated or painful
    When using this product
    Do not apply on other parts of the body
    Avoid contact with eyes . If contact occurs, rinse eyes thoroughly with water.
    Do not apply directly to wound or open cut.
    Stop use and ask doctor if rash or irritation on scalp develops and lasts .
    Store at room temperature

  • DOSAGE & ADMINISTRATION

    For external use only

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    DONG SUNG MONELYN 
    zinc pyrithione suspension, panthenol, niacinamide, biotin shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70778-0002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PANTHENOL (UNII: WV9CM0O67Z) (PANTHENOL - UNII:WV9CM0O67Z) PANTHENOL0.5 g  in 100 mL
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC2.1 g  in 100 mL
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE0.3 g  in 100 mL
    BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN0.06 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70778-0002-1500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/30/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/30/2016
    Labeler - Daolcosmetic Co.,ltd (688279560)
    Registrant - Daolcosmetic Co.,ltd (688279560)
    Establishment
    NameAddressID/FEIBusiness Operations
    Daolcosmetic Co.,ltd688279560manufacture(70778-0002)