SCALP DEEP CLEANSING-SHAMPOO- dexpanthenol, niacinamide, salicylic acid shampoo

Scalp deep cleansing-shampoo by

Drug Labeling and Warnings

Scalp deep cleansing-shampoo by is a Otc medication manufactured, distributed, or labeled by Y2K Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

SCALP DEEP CLEANSING-SHAMPOO 
dexpanthenol, niacinamide, salicylic acid shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83472-501
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXPANTHENOL (UNII: 1O6C93RI7Z) (DEXPANTHENOL - UNII:1O6C93RI7Z)	DEXPANTHENOL	0.2 g  in 100 mL
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	0.1 g  in 100 mL
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83472-501-01	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/01/2023

Labeler - Y2K Co., Ltd. (695705051)

Registrant - Y2K Co., Ltd. (695705051)

Establishment
Name	Address	ID/FEI	Business Operations
Y2K Co., Ltd.		695705051	manufacture(83472-501)