Label: MIRACLE STEMCELL ALL-IN-ONE- dexpanthenol, niacinamide shampoo

  • NDC Code(s): 24765-001-01
  • Packager: PHARMACAL-INTERNATIONAL. CO., LTD
  • 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 December 21, 2023

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  • Actvie Ingrdients                                       Purpose

    Dexpanthenol 0.2%                                     Hair Conditionin
    Niacinamide 0.1%                                       Hair Conditionin

  • PURPOSE

  • Indication and Usage

    Helps scalp care to prevent hair loss
    Helps nourish hair
    Promotes healthy hair

  • Warnings

    Warnings

    ■ For external use only

    ■ Do not use on damaged or broken skin

    ■ Do not get into eyes. If contact occurs, rinse eyes thoroughly with water.

    ■ Keep out of reach of children

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children 

  • Directions

    After sufficiently wetting the hair and scalp with water, massage the scalp evenly with 3-5mlWait for at least 3 minutes while foaming and wash thoroughly.

  • Inactive Ingredients

    Water, Sodium C14-16 Olefin Sulfonate, Lauramidopropyl Betaine, Disodium Laureth Sulfosuccinate, Lauryl Glucoside, Butylene Glycol, Sodium Chloride, PEG-60 Hydrogenated Castor Oil, Fragrance, 1,2-Hexanediol, Sodium Benzoate, Trideceth-10, Citric Acid, Polyquaternium-10, Menthol, Caprylyl Glycol, Tetradecene, Hexadecene, Sodium Sulfate, Cocamide Methyl MEA, Disodium EDTA, Sodium Citrate, Glycerin, Sodium Acetate, Pentylene Glycol, Isopropyl Alcohol, Camellia Japonica Leaf Extract, Ceratonia Siliqua (Carob) Fruit Extract, Diospyros Kaki Fruit Extract, Lecithin, Sodium Phosphate, Glycine, Serine, Glutamic Acid, Lavandula Angustifolia (Lavender) Extract, Rosmarinus Officinalis (Rosemary) Extract, Origanum Vulgare Flower/Leaf/Stem Extract, Thymus Vulgaris (Thyme) Extract, Aspartic Acid, Leucine, Alanine, Lysine, Arginine, Tyrosine, Phenylalanine, Valine, Threonine, Proline, Isoleucine, Tocopherol, Histidine, Methionine, Cysteine, Citronellol, Limonene, Linalool

  • Product label

    image description
  • INGREDIENTS AND APPEARANCE
    MIRACLE STEMCELL ALL-IN-ONE 
    dexpanthenol, niacinamide shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24765-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DEXPANTHENOL (UNII: 1O6C93RI7Z) (DEXPANTHENOL - UNII:1O6C93RI7Z) DEXPANTHENOL0.2 g  in 100 g
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    OREGANO FLOWERING TOP (UNII: 7K91ZBK8GJ)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
    LAURAMIDOPROPYL BETAINE (UNII: 23D6XVI233)  
    DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TRIDECETH-10 (UNII: G624N6MSBA)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)  
    MENTHOL (UNII: L7T10EIP3A)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TETRADECENE (MIXED ISOMERS) (UNII: 5R30W51348)  
    HEXADECENE (MIXED ISOMERS) (UNII: 38H8547VP0)  
    SODIUM SULFATE (UNII: 0YPR65R21J)  
    POLYQUATERNIUM-68 (UNII: R76MNN6P72)  
    COCOYL METHYL MONOETHANOLAMINE (UNII: 79G1T427CF)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM ACETATE (UNII: 4550K0SC9B)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    CAMELLIA JAPONICA LEAF (UNII: 4E3VE6KTLY)  
    CAROB (UNII: 5MG5Z946UO)  
    PERSIMMON (UNII: 4V023DD7KL)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    GLYCINE (UNII: TE7660XO1C)  
    SERINE (UNII: 452VLY9402)  
    GLUTAMIC ACID (UNII: 3KX376GY7L)  
    LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)  
    ROSEMARY (UNII: IJ67X351P9)  
    THYME (UNII: CW657OBU4N)  
    ASPARTIC ACID (UNII: 30KYC7MIAI)  
    LEUCINE (UNII: GMW67QNF9C)  
    ALANINE (UNII: OF5P57N2ZX)  
    LYSINE (UNII: K3Z4F929H6)  
    ARGININE (UNII: 94ZLA3W45F)  
    TYROSINE (UNII: 42HK56048U)  
    PHENYLALANINE (UNII: 47E5O17Y3R)  
    VALINE (UNII: HG18B9YRS7)  
    THREONINE (UNII: 2ZD004190S)  
    PROLINE (UNII: 9DLQ4CIU6V)  
    ISOLEUCINE (UNII: 04Y7590D77)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    HISTIDINE (UNII: 4QD397987E)  
    METHIONINE (UNII: AE28F7PNPL)  
    CYSTEINE (UNII: K848JZ4886)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:24765-001-01300 g in 1 BOTTLE; Type 0: Not a Combination Product12/08/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other12/08/2023
    Labeler - PHARMACAL-INTERNATIONAL. CO., LTD (557805060)
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