Label: BREXTEM S- niacinamide liquid
- NDC Code(s): 83630-010-01, 83630-010-02
- Packager: Brexogen Inc.
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated September 1, 2023
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient(s)
- Purpose
- Use(s)
-
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
- Directions
- Questions
-
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 liquidProduct 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)