BREXTEM H- panthenol 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.

----------

Active ingredient(s)

Panthenol 0.19%

Purpose

Hair elasticity

Use(s)

■ Improves effects of hair elasticity

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 scalp.

Questions

■ info@brexogen.com

Inactive ingredients

Powder: Mannitol, Human Cord Blood Induced Pluripotent Cell Exosomes


Solution: Water, Alcohol Denat., Methylpropanediol, Niacinamide, Polyquaternium-7, Saccharomyces Cerevisiae Extract, Hydrolyzed Keratin, Menthol, Allantoin, Butylene Glycol, Tripeptide-29, Glycerin, Sodium Benzoate, Ethylhexylglycerin, Polyglyceryl-10 Laurate, Biotin, Cornus Officinalis Fruit Extract, Alisma Orientale Tuber Extract, Paeonia Suffruticosa Root Extract, Smilax Glabra Root Extract, Dioscorea Japonica Root Extract, Rehmannia Glutinosa Root Extract, Caprylyl Glycol, 1,2-Hexandiol

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of box

BREXTEM H 
panthenol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83630-020
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Panthenol (UNII: WV9CM0O67Z) (PANTHENOL - UNII:WV9CM0O67Z) Panthenol0.19 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Alcohol (UNII: 3K9958V90M)  
Methylpropanediol (UNII: N8F53B3R4R)  
Niacinamide (UNII: 25X51I8RD4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83630-020-024 in 1 BOX08/01/2023
1NDC:83630-020-015 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(83630-020)

Revised: 9/2023
Document Id: af4cbf3a-d9b9-4499-823e-f9df9998e983
Set id: 590a26d6-6dd8-4890-8417-5c9a973314ef
Version: 1
Effective Time: 20230901
 
Brexogen Inc.