Dosage and administration
■ Gently mix with BREXTEM powder to dissolve the mixture. Take proper amount and gently apply onto the skin.
BREXTEM S
- Manufacturer
- Brexogen Inc. | Enveco Cosmetic Co., Ltd.
- Effective date
- 2023-09-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:26:33
Label at a glance#
ProductBREXTEM S
Active ingredientNiacinamide
Label structure9 sections
Label contents#
Full prescribing information#
Active ingredient(s)
Niacinamide 2.0%
Purpose
Skin Brightening
Use(s)
■ Helps brighten skin tone.
Warnings
For external use only
1.Discontinue use if signs of irritation or rashes appear. If symptoms get worse, consult with a dermatologist. 1) In case of swelling, itching, or other side effects while or after using this product.
2. Do not apply to open wounds.
3. Avoid contact with eyes.
4. Precautions for storage and handling.
5. Keep in the refrigerator at 2-6℃.
6. Keep out of reach of children
7. Avoid direct sunlight
KEEP OUT OF REACH OF CHILDREN
KEEP OUT OF REACH OF CHILDREN
Directions
■ Gently mix with BREXTEM powder to dissolve the mixture. Take proper amount and gently apply onto the skin.
Questions
■ info@brexogen.com
Inactive ingredients
Powder: Mannitol, Human Cord Blood Induced Pluripotent Cell Exosomes
Solution: Water, Dipropylene Glycol, Glycerin, Butylene Glycol, Allantoin, Myrothamnus Flabellifolia Callus CultureExtract, Propolis Extract, 1,2-Hexandiol, Caprylyl Glycol, Adenosine, Copper Tripeptide-1, Acetyl Hexapeptide-8, Palmitoyl Pentapeptide-4, Palmitoyl Tetrapeptide-7, Palmitoyl Tripeptide-1, Tripeptide-29, Diospyros Kaki Fruit Extract, Camellia Japonica Leaf Extract, Ceratonia Siliqua (Carob) Fruit Extract, Rubus Idaeus (Raspberry) Fruit Extract, Polyglyceryl-10 Laurate, Ethylhexylglycerin
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 83630-010-02 | 2025-11-25 | C162847 | 48780-1 | 1030e365-6960-111a-e063-dadaa90a10e2 | 1a5b3fbc-cb8b-41f4-ae97-524587dd80d6 |
| 83630-010-02 | 2024-07-30 | C162847 | 48780-1 | 1030e365-6960-111a-e063-dadaa90a10e2 | 1a5b3fbc-cb8b-41f4-ae97-524587dd80d6 |
| 83630-010-02 | 2024-01-30 | C162847 | 48780-1 | 1030e365-6960-111a-e063-dadaa90a10e2 | 1a5b3fbc-cb8b-41f4-ae97-524587dd80d6 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- BREXTEM S
- Niacinamide
- Water
- Dipropylene Glycol
- Glycerin
- Butylene Glycol
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 83630-010 | 83630-010-01, 83630-010-02 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Niacinamide | 25X51I8RD4 | ACTIB |
| Water | 059QF0KO0R | IACT |
| Dipropylene Glycol | E107L85C40 | IACT |
| Glycerin | PDC6A3C0OX | IACT |
| Butylene Glycol | 3XUS85K0RA | IACT |
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 |
|---|---|---|---|---|---|---|
| 4467133e-6be0-9eff-e063-6394a90abe0d | 1a5b3fbc-cb8b-41f4-ae97-524587dd80d6 | 2025-11-25 | Warnings | 1a5b3fbc-cb8b-41f4-ae97-524587dd80d6 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.