Label: SCALP DEEP CLEANSING-SHAMPOO- dexpanthenol, niacinamide, salicylic acid 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 January 4, 2024

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  • Active Ingredients

    Dexpanthenol 0.2

    Niacinamide 0.1%

    Salicylic Acid 0.2%

  • Purposes

    Dexpanthenol 0.2-------------------------------------- soothing

    Niacinamide 0.1%.............................................Nutrition

    Salicylic Acid 0.2%---------------------------------- Exfoliating

  • Uses

    • helps scalp care for healthy, fuller hair

    • if used as directed, promotes healthy, revitalized

    scalp and hair

  • Warnings

    For external use only

  • Warnings

    Do not use on damaged or broken skin

  • Warnings

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Warnings

    Stop use and ask a doctor if rash occurs

  • Warnings

    When using this product

    Rinse with water to remove, keep out of eyes.

  • Directions

    Brush hair to remove buildup and dirt, then wet hair and scalp with lukewarm water

    -> Dispense an appropriate amount of shampoo into the palm of your hand, gently work into a lather,

    and rub in acupressure for 1~2 minutes, using fingerprints (not nails)

    -> Rinse thoroughly in lukewarm water and air dry. If using a blow dryer, dry with a cool airflow

  • Inactive Ingredients

    Water, Disodium Laureth Sulfosuccinate, Lauryl Glucoside, Lauryl Betaine, Sodium Chloride, Glycerine, Decyl Glucoside, Octyldodeceth-25, Butylene Glycol, Hibiscus Abelmoschus Extract, Polyquaternium-10, Sodium Benzoate, Potassium Sorbate,

    Citric Acid, Menthol, Rosemary Oil, Eucalyptus oil, Glycine, Serine, Glutamic Acid, Aspartic Acid, Leucine, Alanine, Lysine, Arginine, Tyrosine, Phenylalanine, Valine, Threonine, Proline, Isoleucine, Histidine, Methionine, Cysteine, Piroctone Olamine, Limonene

  • Label

    Scalp deep cleansing shampoo

  • INGREDIENTS AND APPEARANCE
    SCALP DEEP CLEANSING-SHAMPOO 
    dexpanthenol, niacinamide, salicylic acid shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83472-511
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXPANTHENOL (UNII: 1O6C93RI7Z) (DEXPANTHENOL - UNII:1O6C93RI7Z) DEXPANTHENOL0.2 g  in 100 mL
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE0.1 g  in 100 mL
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    GLYCINE (UNII: TE7660XO1C)  
    SERINE (UNII: 452VLY9402)  
    GLUTAMIC ACID (UNII: 3KX376GY7L)  
    ASPARTIC ACID (UNII: 30KYC7MIAI)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    MENTHOL (UNII: L7T10EIP3A)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    LEUCINE (UNII: GMW67QNF9C)  
    VALINE (UNII: HG18B9YRS7)  
    HISTIDINE (UNII: 4QD397987E)  
    ALANINE (UNII: OF5P57N2ZX)  
    PHENYLALANINE (UNII: 47E5O17Y3R)  
    ISOLEUCINE (UNII: 04Y7590D77)  
    METHIONINE (UNII: AE28F7PNPL)  
    PIROCTONE OLAMINE (UNII: A4V5C6R9FB)  
    TYROSINE (UNII: 42HK56048U)  
    CYSTEINE (UNII: K848JZ4886)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    ARGININE (UNII: 94ZLA3W45F)  
    THREONINE (UNII: 2ZD004190S)  
    PROLINE (UNII: 9DLQ4CIU6V)  
    LYSINE (UNII: K3Z4F929H6)  
    ABELMOSCHUS MANIHOT WHOLE (UNII: P51K8V050N)  
    LAURYL BETAINE (UNII: Y4P927Q133)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    OCTYLDODECETH-25 (UNII: F8934HEL3M)  
    POLYQUATERNIUM-10 (20000 MPA.S AT 2%) (UNII: N2GK4S7X4T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83472-511-01500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/01/2023
    Labeler - Y2K Co., Ltd. (695705051)
    Registrant - Y2K Co., Ltd. (695705051)
    Establishment
    NameAddressID/FEIBusiness Operations
    Y2K Co., Ltd.695705051manufacture(83472-511)