ECOSOM- salicylic acid, pyrithione zinc shampoo 
ECOSOM.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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Ecosom Shampoo

Ecosom Shampoo

ecosom shampoo antiseborrheic

Salicylic Acid (0.2%)
Pyrithione Zinc (0.6%)

Antiseborrheic

Keep out of reach of children
- Do not swallow. In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Helps prevent recurrence of flaking and itching associated with dandruff

Warnings
For external use only
Do not use on damaged or broken scalp
When using this product
- Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
Stop use and ask doctor if rash or irritation on scalp develops and lasts.
Store at room temperature

Apply the adequate amount on scalp and hair evenly. After 2-3 minutes, rinse with lukewarm water.

Dexpanthenol, Potassium Hydroxide, DisodiumEthylenediaminetetraacetate, Carbomer, Mulberry Root Extract, Sodium PolyoxyethyleneLaurylether Sulfate, Ammonium Lauryl Sulfate Solution, Cocamide DEA, Cocamidopropyl Betaine, Polyquaternium-7, Methylparaben, Propylparaben, Diamond098, Calamus Root Extract, Green Tea Extract, Ginseng Extract, Ethanol, Purified water

ECOSOM 
salicylic acid, pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69856-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.2   in 300 mL
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC0.6   in 300 mL
Inactive Ingredients
Ingredient NameStrength
DEXPANTHENOL (UNII: 1O6C93RI7Z)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
DISODIUM ETHYLENEDIAMINEDIACETATE (UNII: EQL53S5L0F)  
CARBOMER 1342 (UNII: 809Y72KV36)  
WHITE MULBERRY (UNII: MN25R0HH5A)  
SODIUM LAURETH-12 SULFATE (UNII: 8M492LDU23)  
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)  
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
ACORUS CALAMUS ROOT (UNII: XY1K7KIQ0F)  
DIAMOND (UNII: 6GRV67N0U2)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
ASIAN GINSENG (UNII: CUQ3A77YXI)  
ALCOHOL (UNII: 3K9958V90M)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69856-101-021 in 1 PACKAGE
1NDC:69856-101-01300 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/18/2015
Labeler - ECOSOM.Co.,Ltd. (689514366)
Registrant - ECOSOM.Co.,Ltd. (689514366)
Establishment
NameAddressID/FEIBusiness Operations
ECOSOM.Co.,Ltd.689514366manufacture(69856-101)

Revised: 7/2015
Document Id: f2c91314-6cbb-4f60-81a1-520ccd866e77
Set id: 7c4245b4-e576-4fba-94c2-972e9d25a1f4
Version: 4
Effective Time: 20150715
 
ECOSOM.Co.,Ltd.