Label: BREXTEM H- panthenol liquid

  • NDC Code(s): 83630-020-01, 83630-020-02
  • Packager: Brexogen Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated September 1, 2023

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  • 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

  • INGREDIENTS AND APPEARANCE
    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)
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