BREXTEM H- panthenol liquid

BREXTEM H by

Drug Labeling and Warnings

BREXTEM H 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)

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

INGREDIENTS AND APPEARANCE

BREXTEM H 
panthenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83630-020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Panthenol (UNII: WV9CM0O67Z) (PANTHENOL - UNII:WV9CM0O67Z)	Panthenol	0.19 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Alcohol (UNII: 3K9958V90M)
Methylpropanediol (UNII: N8F53B3R4R)
Niacinamide (UNII: 25X51I8RD4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83630-020-02	4 in 1 BOX	08/01/2023
1	NDC: 83630-020-01	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(83630-020)