MIRACLE STEMCELL ALL-IN-ONE- dexpanthenol, niacinamide shampoo 
PHARMACAL-INTERNATIONAL. CO., LTD

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.

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Actvie Ingrdients                                       Purpose

Dexpanthenol 0.2%                                     Hair Conditionin
Niacinamide 0.1%                                       Hair Conditionin

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 

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
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)

Revised: 12/2023
Document Id: 0d0b0996-2086-e38b-e063-6294a90ae522
Set id: e7104175-58fc-4389-9a87-7027858fbf7d
Version: 1
Effective Time: 20231221
 
PHARMACAL-INTERNATIONAL. CO., LTD