SOLEP PREMIER HI GRO- panthenol, zinc pyrithione, salicylic acid shampoo

SOLEP PREMIER HI GRO by

Drug Labeling and Warnings

SOLEP PREMIER HI GRO by is a Otc medication manufactured, distributed, or labeled by Kobizstar Co., Ltd., Ester Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

SOLEP PREMIER HI GRO 
panthenol, zinc pyrithione, salicylic acid shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81077-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Panthenol (UNII: WV9CM0O67Z) (PANTHENOL - UNII:WV9CM0O67Z)	Panthenol	1.50 g  in 300 mL
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	0.90 g  in 300 mL
Salicylic Acid (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	Salicylic Acid	0.60 g  in 300 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Potassium Cocoyl Glycinate (UNII: WZ70FUF22U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81077-010-02	1 in 1 CARTON	11/01/2020
1	NDC: 81077-010-01	300 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/01/2020

Labeler - Kobizstar Co., Ltd. (688506017)

Registrant - Kobizstar Co., Ltd. (688506017)

Establishment
Name	Address	ID/FEI	Business Operations
Ester Co., Ltd.		688425766	manufacture(81077-010)