SOLEP PREMIER HI GRO- panthenol, zinc pyrithione, salicylic acid shampoo 
Kobizstar 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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ACTIVE INGREDIENT(S)

Panthenol 0.50%
Zinc Pyrithione 0.30%
Salicylic Acid 0.20%

INACTIVE INGREDIENTS

Water, Potassium Cocoyl Glycinate, Lauryl Glucoside, Lauramidopropyl Betaine, Cocamide MIPA, Tetrasodium EDTA, 1,2-Hexanediol, Illicium Verum (Anise) Fruit Extract, Scutellaria Baicalensis Root Extract, Butylene Glycol, Pantolactone, Polyquaternium-10, Menthol, Citric Acid, Coptis Japonica Root Extract, Rhizophora Mangle Callus Culture Extract, Eucalyptus Globulus Leaf Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Lavandula Angustifolia (Lavender) Oil, 1,2-Hexanediol, Ethylhexylglycerin, Aloe Barbadensis Leaf Extract, Opuntia Coccinellifera Fruit Extract, Schisandra Chinensis Fruit Extract, Aronia Arbutifolia Extract, Cordyceps Sinensis Extract, Sparassis Crispa Extract, Dioscorea Japonica Root Extract, Albumen Extract, Hydrolyzed Ginseng Saponins, Saponaria Officinalis Leaf Extract, Hydrolyzed Silk, Hydrolyzed Elastin, Hydrolyzed Keratin, Limonene, Linalool

PURPOSE

Anti-hairloss

WARNINGS

1. Consult with a specialist if there are any abnormal symptoms or side effects such as red spots, swelling or itching when using or after use in direct sunlight. 2. Avoid using on wounded areas. 3. Precautions for storage and handling A) Keep out of reach of children. B) Store away from direct sunlight. 4. In case of eye contact, wash it off immediately. 5. It may cause hair loss or discoloration if not washed off with water after use.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Use(s)

■ Helps relieve hair loss.

Directions

Use 1 time per day as following.
1) Wet hair and scalp with lukewarm water
2) Apply adequate amount and work lather on hair and scalp.
3) Rinse thoroughly after 2-3 minutes.

Other Information

■ If any defect in this product, you are compensated in accordance with “Consumer Dispute Resolution Criteria” notified by Fair Trade Commission.

Questions

■ www.solepkorea.com / kbeauty@kobizstar.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

SOLEP PREMIER HI GRO 
panthenol, zinc pyrithione, salicylic acid shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81077-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Panthenol (UNII: WV9CM0O67Z) (PANTHENOL - UNII:WV9CM0O67Z) Panthenol1.50 g  in 300 mL
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC0.90 g  in 300 mL
Salicylic Acid (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) Salicylic Acid0.60 g  in 300 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Potassium Cocoyl Glycinate (UNII: WZ70FUF22U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81077-010-021 in 1 CARTON11/01/2020
1NDC:81077-010-01300 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other11/01/2020
Labeler - Kobizstar Co., Ltd. (688506017)
Registrant - Kobizstar Co., Ltd. (688506017)
Establishment
NameAddressID/FEIBusiness Operations
Ester Co., Ltd.688425766manufacture(81077-010)

Revised: 11/2020
Document Id: 5992e67f-12df-42a8-b427-35cc6828e373
Set id: 5ae01fd8-8a20-4c24-8d8d-4de491a72f80
Version: 1
Effective Time: 20201117
 
Kobizstar Co., Ltd.