SOLEP PREMIER HI GRO TONIC

Manufacturer
Kobizstar Co., Ltd. | Ester Co., Ltd.
Effective date
2020-11-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:33:51

Label at a glance#

ProductSOLEP PREMIER HI GRO TONIC
Active ingredientMenthol, Panthenol, Salicylic Acid
Label structure10 sections

Dosage and administration

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

Label contents#

Full prescribing information#

ACTIVE INGREDIENT(S)

OTC - ACTIVE INGREDIENT SECTION

Menthol 0.29%
Panthenol 0.22%
Salicylic Acid 0.25%

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

Anti-hairloss

WARNINGS

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

Use(s)

INDICATIONS & USAGE SECTION

■ Helps relieve hair loss.

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other Information

OTHER SAFETY INFORMATION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81077-020-022025-01-30C16284748780-12cef2736-7066-d83d-e063-dadaa90ab31fbe18abc9-df84-4455-a26e-470841af30c6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81077-020-01SOLEP PREMIER HI GRO TONIC100 mL in 1 BOTTLE, SPRAYSPRAY1001
81077-020-02SOLEP PREMIER HI GRO TONIC1 in 1 CARTONSPRAY11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81077-020SOLEP PREMIER HI GRO TONIC (MENTHOL, PANTHENOL, SALICYLIC ACID) SPRAY [KOBIZSTAR CO., LTD.]1Legacy NDC, 2 package rows20201118_be18abc9-df84-4455-a26e-470841af30c6.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81077-02081077-020-01, 81077-020-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
af3b1396-8a36-464a-ba7c-949fe85d35b1be18abc9-df84-4455-a26e-470841af30c62020-11-17WarningsExact identifier
spl id: af3b1396-8a36-464a-ba7c-949fe85d35b1
spl set id: be18abc9-df84-4455-a26e-470841af30c6

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.