SOLEP PREMIER HI GRO AMPOULE PACK

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 23:33:48

Label at a glance#

ProductSOLEP PREMIER HI GRO AMPOULE PACK
Active ingredientPanthenol, Menthol, 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

Panthenol 0.50%
Menthol 0.29%
Salicylic Acid 0.25%

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

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

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81077-030-022025-01-30C16284748780-12cef2736-6f40-d83d-e063-dadaa90ab31f0a27152e-1118-43ea-a3a3-3a0e1b9bae2d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81077-030-01SOLEP PREMIER HI GRO AMPOULE PACK40 mL in 1 TUBELIQUID401
81077-030-02SOLEP PREMIER HI GRO AMPOULE PACK1 in 1 CARTONLIQUID11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81077-030SOLEP PREMIER HI GRO AMPOULE PACK (PANTHENOL, MENTHOL, SALICYLIC ACID) LIQUID [KOBIZSTAR CO., LTD.]1Legacy NDC, 2 package rows20201118_0a27152e-1118-43ea-a3a3-3a0e1b9bae2d.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
81077-03081077-030-01, 81077-030-02

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
5d6f5f27-8b9a-4a20-8cb3-a934f005a3970a27152e-1118-43ea-a3a3-3a0e1b9bae2d2020-11-17WarningsExact identifier
spl id: 5d6f5f27-8b9a-4a20-8cb3-a934f005a397
spl set id: 0a27152e-1118-43ea-a3a3-3a0e1b9bae2d

Reported adverse events (FAERS/openFDA)#

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