BREXTEM S- niacinamide liquid

BREXTEM S by

Drug Labeling and Warnings

BREXTEM S by is a Otc medication manufactured, distributed, or labeled by Brexogen Inc., Enveco Cosmetic Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

BREXTEM S 
niacinamide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83630-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Niacinamide (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	Niacinamide	2.0 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Dipropylene Glycol (UNII: E107L85C40)
Glycerin (UNII: PDC6A3C0OX)
Butylene Glycol (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83630-010-02	4 in 1 BOX	08/01/2023
1	NDC: 83630-010-01	5 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/01/2023

Labeler - Brexogen Inc. (695721823)

Registrant - Brexogen Inc. (695721823)

Establishment
Name	Address	ID/FEI	Business Operations
Enveco Cosmetic Co., Ltd.		689061861	manufacture(83630-010)