OTC - ACTIVE INGREDIENT SECTION
-menthol, Salicylic acid, Dexpanthenol
The Fact Hair Care Scalp Booster Ampoule
- Manufacturer
- Interkos Co.,Ltd.
- Effective date
- 2023-02-11
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:54:00
Label at a glance#
ProductThe Fact Hair Care Scalp Booster Ampoule
Active ingredientDEXPANTHENOL, LEVOMENTHOL, SALICYLIC ACID
Label structure8 sections
Label contents#
Full prescribing information#
INACTIVE INGREDIENT SECTION
Water
Alcohol
PEG-60 Hydrogenated Castor Oil
Trideceth-10
Fragrance
Butylene Glycol
1,2-Hexanediol
Caprylyl Glycol
Tromethamine
Ginkgo Biloba Leaf Extract
Sophora Flavescens Extract
Urtica Dioica (Nettle) Extract
Carthamus Tinctorius (Safflower) Flower Extract
Brassica Oleracea Italica Extract
Carbomer
Pueraria Lobata Root Extract
Illicium Verum (Anise) Fruit Extract
Sodium Hyaluronate
OTC - PURPOSE SECTION
Helps treat hair loss symptoms
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
KEEP OUT OF REACH OF THE CHILDREN
INDICATIONS & USAGE SECTION
Shake the product thoroughly, then apply evenly onto the scalp with the massage roller.
WARNINGS SECTION
1) After application, if there are any abnormal symptoms or side effects such as red spots, swelling, or itching in the area from direct sunlight, please consult with a specialist.
2) Avoid using the product on areas with scarring or open wounds.
3) Storage and handling
A) Keep out of reach of children
B) Keep away from direct sunlight
4) Keep out of eyes, if this occurs, rinse immediately with water
5) For any adverse allergic reactions, please consult your doctor or pharmacist before use.
6) Not for children under the age of 3
7) Those with diabetes, blood circulation disorder, renal failure, infection, redness, hypersensitivity to salicylic acid, etc., and those who are pregnant or likely to become pregnant may experience skin or body hypersensitivity or skin adverse reactions (edema, inflammation, etc.). Avoid using the product if symptoms arise
DOSAGE & ADMINISTRATION SECTION
external use only
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1046534 | salicylic acid 0.25 % / dexpanthenol 0.2 % / levomenthol 0.3 % Topical Solution | PSN | 1 |
| 1046534 | dexpanthenol 2 MG/ML / levomenthol 3 MG/ML / salicylic acid 2.5 MG/ML Topical Solution | SCD | 1 |
| 1046534 | dexpanthenol 0.2 % / levomenthol 0.3 % / salicylic acid 0.25 % Topical Solution | SY | 1 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 77049-0013-1 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-85f4-d83d-e063-dadaa90ab31f | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 77049-0013-1 | The Fact Hair Care Scalp Booster Ampoule | 20 mL in 1 TUBE | LIQUID | 20 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 77049-0013 | THE FACT HAIR CARE SCALP BOOSTER AMPOULE (L-MENTHOL, SALICYLIC ACID, DEXPANTHENOL) LIQUID [INTERKOS CO.,LTD.] | 1 | 1 package rows | 20230212_f469f1d3-adc1-a719-e053-2995a90ad08a.zip |
Products#
Every source-derived product name is available through these pages.
- The Fact Hair Care Scalp Booster Ampoule
- L-menthol, Salicylic acid, Dexpanthenol
- BUTYLENE GLYCOL
- DEXPANTHENOL
- WATER
- LEVOMENTHOL
- SALICYLIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 77049-0013 | 77049-0013-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BUTYLENE GLYCOL | 3XUS85K0RA | IACT |
| DEXPANTHENOL | 1O6C93RI7Z | ACTIB |
| WATER | 059QF0KO0R | IACT |
| LEVOMENTHOL | BZ1R15MTK7 | ACTIB |
| SALICYLIC ACID | O414PZ4LPZ | ACTIB |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| f469f1e5-24b1-8ade-e053-2995a90a3028 | f469f1d3-adc1-a719-e053-2995a90ad08a | 2023-02-11 | Warnings | f469f1e5-24b1-8ade-e053-2995a90a3028 f469f1d3-adc1-a719-e053-2995a90ad08a |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.