MOCHEASU ALOPECIA-SHAMPOO- zinc pyrithione, salicylic acid shampoo 
Somi T Na Co., Ltd

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active ingredient

Salicylic Acid 0.2%

Zinc Pyrithione 0.3%

Purpose

Anti dandruff

Use

Hair loss symptom relief shampoo cleanses the scalp of the hair and helps the healthy hair by supplying nutrients as the main ingredient

Warnings

Wash it as soon as it gets into your eyes

Warnings

keep it out of reach of children

Warnings

and keep it out of direct sunlight

Warnings

Stop use and ask a doctor if irritation or rash occurs.

Directions

After fully wetting hair with water, apply an appropriate amount to hair and scalp, fuiiy lather and wash off with lukewarm water.

Inactive ingredients

Water, Decyl Glucoside, Lauramidopropyl Betaine, Potassium Cocoyl Glycinate, Lauryl Betaine, Disodium Cocoamphodiacetate, Cocamide MEA, TEA-Cocoyl Glutaminate, Olea Europaea (Olive) Fruit Oil, Glycerin, Yucca Vera Leaf/Root Extract, Lawsonia Inermis (Henna) Extract, Menthol, Niacinamide, Allantoin, Hippophae Rhamnoides Fruit Extract, Urtica Dioica (Nettle) Extract, Camellia Sinensis Leaf Extract, Lavandula Angustifolia (Lavender) Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Crambe Abyssinica Seed Oil, Morus Alba Twig Extract, Morus Alba Leaf Extract, Morus Alba Root Extract, Ficus Carica (Fig) Fruit Extract, Salmon Egg Extract, Acorus Calamus Root Extract, Scutellaria Baicalensis Root Extract, Cysteine, Lactuca Scariola Sativa (Lettuce) Leaf Extract, Polygonum Multiflorum Root Extract, Brassica Oleracea Capitata (Cabbage) Leaf Extract, Allium Cepa (Onion) Bulb Extract, Sophora Flavescens Root Extract, Panax Ginseng Root Extract, Houttuynia Cordata Extract, Sodium Chloride, 1,2-Hexanediol, Betaine, Guar Hydroxypropyltrimonium Chloride, Alcohol, Cetearyl Alcohol, Polyquaternium-7, Dimethicone, Disodium EDTA

Package Label

300ml NDC: 79546-201-01 Label 1

300ml NDC: 79546-201-01 Label 2

MOCHEASU ALOPECIA-SHAMPOO 
zinc pyrithione, salicylic acid shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79546-201
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC0.3 g  in 100 mL
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
POTASSIUM COCOYL GLYCINATE (UNII: WZ70FUF22U)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
PANTHENOL (UNII: WV9CM0O67Z)  
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
CYSTEINE (UNII: K848JZ4886)  
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)  
ASIAN GINSENG (UNII: CUQ3A77YXI)  
MORUS ALBA STEM (UNII: 05Y42QCG2T)  
SALMON, UNSPECIFIED (UNII: 6122W2M0GB)  
ACORUS CALAMUS ROOT (UNII: XY1K7KIQ0F)  
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
LETTUCE (UNII: 5PO6NN3RRJ)  
REYNOUTRIA MULTIFLORA ROOT (UNII: AUZ3VD75MC)  
ONION (UNII: 492225Q21H)  
HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
BETAINE (UNII: 3SCV180C9W)  
ALCOHOL (UNII: 3K9958V90M)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
LAURYL BETAINE (UNII: Y4P927Q133)  
TRIETHANOLAMINE COCOYL GLUTAMINATE (UNII: 2R6QKD2Y0M)  
LAWSONIA INERMIS FLOWERING TOP (UNII: UF2093XE64)  
MENTHOL (UNII: L7T10EIP3A)  
NIACINAMIDE (UNII: 25X51I8RD4)  
ALLANTOIN (UNII: 344S277G0Z)  
URTICA DIOICA LEAF (UNII: X6M0DRN46Q)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
COCO MONOETHANOLAMIDE (UNII: C80684146D)  
YUCCA SCHIDIGERA (UNII: 08A0YG3VIC)  
LAURAMIDOPROPYL BETAINE (UNII: 23D6XVI233)  
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
GLYCERIN (UNII: PDC6A3C0OX)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
ROSEMARY OIL (UNII: 8LGU7VM393)  
CABBAGE (UNII: GW0W1Y9I97)  
WATER (UNII: 059QF0KO0R)  
HIPPOPHAE RHAMNOIDES FRUIT (UNII: AVL0R9111T)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
CRAMBE HISPANICA SUBSP. ABYSSINICA SEED OIL (UNII: 0QW9S92J3K)  
MORUS ALBA LEAF (UNII: M8YIA49Q2P)  
MORUS ALBA ROOT (UNII: CST1G9BZGD)  
FIG (UNII: TGD87RII2U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79546-201-01300 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/11/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM03207/11/2020
Labeler - Somi T Na Co., Ltd (694085583)
Registrant - Somi T Na Co., Ltd (694085583)
Establishment
NameAddressID/FEIBusiness Operations
Somi T Na Co., Ltd694085583manufacture(79546-201)

Revised: 5/2023
Document Id: fbcb11fb-dcb3-ee80-e053-6294a90ac8d9
Set id: aa25a85e-b823-36e3-e053-2a95a90ad21f
Version: 4
Effective Time: 20230516
 
Somi T Na Co., Ltd