SOLEP PREMIER HI GRO AMPOULE PACK- panthenol, menthol, salicylic acid liquid

SOLEP PREMIER HI GRO AMPOULE PACK by

Drug Labeling and Warnings

SOLEP PREMIER HI GRO AMPOULE PACK 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%
Menthol 0.29%
Salicylic Acid 0.25%

INACTIVE INGREDIENTS

Water, Alcohol, Agave Tequilana Leaf Extract, Opuntia Ficus-Indica Stem Extract, Adenium Obesum Leaf Cell Extract, Myrothamnus Flabellifolia Leaf/Stem Extract, Trehalose, Biotin, Tocopheryl Acetate, Thiamin HCL, Cyanocobalamin, Riboflavin, Pyridoxine, Folic acid, Menadione, Bioflavonoids, Ascorbic Acid, Butylene Glycol, 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, Glycereth-25 PCA Isostearate, Triethanolamine, Carbomer, Pantolactone, Pinus Sylvestris Leaf Extract, Pentylene Glycol, Caprylyl Glycol, Hydroxyethylcellulose, Chlorphenesin, Eucalyptus Globulus Leaf Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Lavandula Angustifolia (Lavender) Oil, PVP, Hydrogenated Lecithin, Squalane, Ceramide NP , Dipotassium Glycyrrhizate, Allantoin, Guaiazulene, Portulaca Oleracea Extract, Centella Asiatica Extract, Camellia Sinensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Citric Acid, Limonene, Linalool, Coptis Japonica Root Extract

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. People who have had allergic symptoms should consult a doctor or pharmacist before use. 6. Do not use for children under 3 years of age. 7. people with hypersensitivity to salicylic acid, diabetes, or blood circulation disorders, renal failure, infection, redness etc., people with during menstruation, during pregnancy, or suspected to be pregnant should avoid using it as there is possibility that the current symptoms of skin or body becoming irritable or abnormal skin reactions(edema, inflammation, etc.) may worsen after use.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Use(s)

■ Helps relieve hair loss.

Directions

■ Shake the product before use, daily apply adequate amount and gently massage the scalp with fingertips to be fully absorbed.

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 AMPOULE PACK 
panthenol, menthol, salicylic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81077-030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Panthenol (UNII: WV9CM0O67Z) (PANTHENOL - UNII:WV9CM0O67Z)	Panthenol	0.20 g  in 40 mL
Menthol (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	Menthol	0.11 g  in 40 mL
Salicylic Acid (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	Salicylic Acid	0.10 g  in 40 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Alcohol (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81077-030-02	1 in 1 CARTON	11/01/2020
1	NDC: 81077-030-01	40 mL in 1 TUBE; 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(81077-030)