SOLEP PREMIER HI GRO TONIC- menthol, panthenol, salicylic acid spray 
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)

Menthol 0.29%
Panthenol 0.22%
Salicylic Acid 0.25%

INACTIVE INGREDIENTS

Aloe Barbadensis Leaf Extract, Alcohol, Opuntia Coccinellifera Fruit Extract, Schisandra Chinensis Fruit Extract, Aronia Arbutifolia Extract, Cordyceps Sinensis Extract, Sparassis Crispa Extract, Butylene Glycol, 1,2-Hexanediol, Ethylhexylglycerin, Centella Asiatica Extract, Asiaticoside, Asiatic Acid, Madecassic Acid, Madecassoside, Propolis Extract, Hydrolyzed Wheat Protein, Hydrolyzed Corn Protein, Avena Sativa (Oat) Protein Extract, Saccharomyces/Soy Protein Ferment, Hydrolyzed Barley Protein, Hydrolyzed Rice Protein, Hydrolyzed Soymilk Protein, Hydrolyzed Yeast Protein, Hydrolyzed Potato Protein, Hydrolyzed Rice Bran Protein, Hydrolyzed Cottonseed Protein, Hydrolyzed Pea Protein, Hydrolyzed Sweet Almond Protein, Hydrolyzed Vegetable Protein, Glycine Soja (Soybean) Protein, Hydrolyzed Hazelnut Protein, Glycereth-25 PCA Isostearate, Pantolactone, Pinus Sylvestris Leaf Extract, Pentylene Glycol, Caprylyl Glycol, Chlorphenesin, Eucalyptus Globulus Leaf Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Lavandula Angustifolia (Lavender) Oil, Betaine, Raffinose, Inositol, Hyaluronic Acid, Histidine, Glutamine, Glycine, Lysine, Arginine, Cysteine, Sodium Citrate, 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. 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

Image of carton

SOLEP PREMIER HI GRO TONIC 
menthol, panthenol, salicylic acid spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81077-020
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) Menthol0.29 g  in 100 mL
Panthenol (UNII: WV9CM0O67Z) (PANTHENOL - UNII:WV9CM0O67Z) Panthenol0.22 g  in 100 mL
Salicylic Acid (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) Salicylic Acid0.25 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Alcohol (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81077-020-021 in 1 CARTON11/01/2020
1NDC:81077-020-01100 mL in 1 BOTTLE, SPRAY; 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(81077-020)

Revised: 11/2020
Document Id: af3b1396-8a36-464a-ba7c-949fe85d35b1
Set id: be18abc9-df84-4455-a26e-470841af30c6
Version: 1
Effective Time: 20201117
 
Kobizstar Co., Ltd.