BREXTEM S- niacinamide liquid 
Brexogen Inc.

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)

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

Image of box

BREXTEM S 
niacinamide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83630-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Niacinamide (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) Niacinamide2.0 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Dipropylene Glycol (UNII: E107L85C40)  
Glycerin (UNII: PDC6A3C0OX)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83630-010-024 in 1 BOX08/01/2023
1NDC:83630-010-015 mL in 1 VIAL; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other08/01/2023
Labeler - Brexogen Inc. (695721823)
Registrant - Brexogen Inc. (695721823)
Establishment
NameAddressID/FEIBusiness Operations
Enveco Cosmetic Co., Ltd.689061861manufacture(83630-010)

Revised: 9/2023
Document Id: ace8f64c-7c32-426a-964e-d9556b93f8db
Set id: 1a5b3fbc-cb8b-41f4-ae97-524587dd80d6
Version: 3
Effective Time: 20230901
 
Brexogen Inc.