Label: VIATREXX-HAIR- pantothenic acid , biotin , estradiol , pork collagen , estriol , heptaminol , interleukin-3 , bos taurus pituitary gland , sus scrofa pituitary gland , progesterone , saw palmetto , silicon dioxide , thyroid, unspecified and zinc spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated March 19, 2019

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  • SPL UNCLASSIFIED SECTION

  • Active Ingredients

    B5/Pantothenic acid (30K), Biotin (30K), Collagen (8X, 200K), Estradiol (200K), Estriol (200K), FGF (6X, 200K), Ginkgo (30K), IL-3 (8X, 200K), Pituitary (6X, 200K), Progesterone (200K), Saw Palmetto (30K), Silicea (200K), Thyroidium (30K), Zinc (30K). 

  • Purpose

    B5/Pantothenic acid
    Biotin
    Collagen
    Estradiol
    Estriol
    FGF
    Ginkgo 
    IL-3
    Pituitary
    Progesterone
    Saw Palmetto
    Silicea
    Thyroidium
    Zinc    		Nutritional support
    Regeneration
    Regeneration
    Hormonal support
    Hormonal support
    Regeneration
    Circulation support
    Immune support
    Regeneration
    Hormonal support
    Hormonal support
    Drainage
    Regeneration
    Nutritional support
  • Uses

    Hair health, hair regeneration & support.

  • Warnings

    Stop use and ask a health care practitioner if symptoms persist for more than five days or worsen. If pregnant or breastfeeding, ask a health care practitioner before use.

  • Dosage

    1-3 spray(s); 1-3 time(s) per day or as recommended by your health care practitioner.

  • Keep this and all medicines out of reach of children.

  • Inactive Ingredients

    20% Alcohol and 80% Water

    Other Information

  • Normal storage use. Do not use if tamper-evident seal is broken or removed.

  • Product availability

    Product may be acquired in 0.5, 30, 50, 100, 250 mL in bottles

    References upon request

    To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

    Distributed by
    Viatrexx Bio Incorporated
    Newark, DE, USA, 19713

    Manufactured by
    8046255 Canada Inc
    Beloeil, Qc, J3G 6S3

    Date of last revision March 2019

    For Questions and comments
    Info@Viatrexx.com
    www.Viatrexx.com

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC: 63776-206-11
    Item: VPC0251

    Viatrexx Bio Incorporated

    Viatrexx-Hair
    Box of 1 X 0.5 mL ampule  
    For Oral and Topical Use 

    Expiry date:                          Lot #:

    Manufactured by: 
    Viatrexx Bio Incorporated  Newark, DE, USA, 19713 
    www.Viatrexx.com 

    Ingredients, homeopathic 

    See insert or www.viatrexx.com 

    Inactives: Alcohol 20%, Water 80%

    NDC: 63776-206-14
    Item: VPC0251

    Viatrexx Bio Incorporated

    Viatrexx-Hair
    Box of 1 X 30 mL spray bottle  
    For Oral and Topical Use 

    Expiry date:                          Lot #:

    Manufactured for: 
    Viatrexx Bio Incorporated  Newark, DE, USA, 19713 
    www.Viatrexx.com 

    Ingredients, homeopathic 
    See insert or www.viatrexx.com 

    Inactives: Alcohol 20%, Water 80%

    NDC: 63776-206-15
    Item: VPC0251

    Viatrexx Bio Incorporated

    Viatrexx-Hair
    Box of 1 X 50 mL spray bottle  
    For Oral and Topical Use 

    Expiry date:                          Lot #:

    Manufactured for: 
    Viatrexx Bio Incorporated  Newark, DE, USA, 19713 
    www.Viatrexx.com 

    Ingredients, homeopathic 

    See insert or www.viatrexx.com 

    Inactives: Alcohol 20%, Water 80%

    Label

    NDC: 63776-206-16
    Item: VPC0251

    Viatrexx Bio Incorporated

    Viatrexx-Hair
    Box of 1 X 100 mL bottle  
    For Oral and Topical Use 

    Expiry date:                          Lot #:

    Manufactured for: 
    Viatrexx Bio Incorporated  Newark, DE, USA, 19713 
    www.Viatrexx.com 

    Ingredients, homeopathic 

    See insert or www.viatrexx.com 

    Inactives: Alcohol 20%, Water 80%

    NDC: 63776-206-17
    Item: VPC0251

    Viatrexx Bio Incorporated

    Viatrexx-Hair
    Box of 1 X 250 mL bottle  
    For Oral and Topical Use 

    Expiry date:                          Lot #:

    Manufactured for: 
    Viatrexx Bio Incorporated  Newark, DE, USA, 19713 
    www.Viatrexx.com 

    Ingredients, homeopathic 

    See insert or www.viatrexx.com 

    Inactives: Alcohol 20%, Water 80%

  • INGREDIENTS AND APPEARANCE
    VIATREXX-HAIR 
    pantothenic acid , biotin , estradiol , pork collagen , estriol , heptaminol , interleukin-3 , bos taurus pituitary gland , sus scrofa pituitary gland , progesterone , saw palmetto , silicon dioxide , thyroid, unspecified and zinc spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63776-206
    Route of AdministrationORAL, TOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Pantothenic Acid (UNII: 19F5HK2737) (Pantothenic Acid - UNII:19F5HK2737) Pantothenic Acid30 [kp_C]  in 1 mL
    Biotin (UNII: 6SO6U10H04) (Biotin - UNII:6SO6U10H04) Biotin30 [kp_C]  in 1 mL
    Estradiol (UNII: 4TI98Z838E) (Estradiol - UNII:4TI98Z838E) Estradiol200 [kp_C]  in 1 mL
    Pork Collagen (UNII: I8442U2G7J) (Pork Collagen - UNII:I8442U2G7J) Pork Collagen200 [kp_C]  in 1 mL
    Estriol (UNII: FB33469R8E) (Estriol - UNII:FB33469R8E) Estriol200 [kp_C]  in 1 mL
    Ginkgo (UNII: 19FUJ2C58T) (Ginkgo - UNII:19FUJ2C58T) Ginkgo30 [kp_C]  in 1 mL
    Interleukin-3 (UNII: A802907MI4) (Interleukin-3 - UNII:A802907MI4) Interleukin-3200 [kp_C]  in 1 mL
    Bos Taurus Pituitary Gland (UNII: 7JM57I419K) (Bos Taurus Pituitary Gland - UNII:7JM57I419K) Bos Taurus Pituitary Gland200 [kp_C]  in 1 mL
    Sus Scrofa Pituitary Gland (UNII: E8S87O660T) (Sus Scrofa Pituitary Gland - UNII:E8S87O660T) Sus Scrofa Pituitary Gland200 [kp_C]  in 1 mL
    Progesterone (UNII: 4G7DS2Q64Y) (Progesterone - UNII:4G7DS2Q64Y) Progesterone200 [kp_C]  in 1 mL
    Saw Palmetto (UNII: J7WWH9M8QS) (Saw Palmetto - UNII:J7WWH9M8QS) Saw Palmetto30 [kp_C]  in 1 mL
    Silicon Dioxide (UNII: ETJ7Z6XBU4) (Silicon Dioxide - UNII:ETJ7Z6XBU4) Silicon Dioxide200 [kp_C]  in 1 mL
    Thyroid, Unspecified (UNII: 0B4FDL9I6P) (Thyroid, Unspecified - UNII:0B4FDL9I6P) Thyroid, Unspecified30 [kp_C]  in 1 mL
    Zinc (UNII: J41CSQ7QDS) (Zinc - UNII:J41CSQ7QDS) Zinc30 [kp_C]  in 1 mL
    Basic Fibroblast Growth Factor (Human) (UNII: S3529G9M9V) (Basic Fibroblast Growth Factor (Human) - UNII:S3529G9M9V) Basic Fibroblast Growth Factor (Human)200 [kp_C]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Alcohol (UNII: 3K9958V90M)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63776-206-111 in 1 BOX07/05/2019
    10.5 mL in 1 AMPULE; Type 0: Not a Combination Product
    2NDC:63776-206-141 in 1 BOX07/05/2019
    230 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    3NDC:63776-206-151 in 1 BOX07/05/2019
    350 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    4NDC:63776-206-161 in 1 BOX07/05/2019
    4100 mL in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:63776-206-171 in 1 BOX07/05/2019
    5250 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/29/2019
    Labeler - VIATREXX BIO INCORPORATED (078419880)
    Establishment
    NameAddressID/FEIBusiness Operations
    8046255 Canada Inc200651455api manufacture(63776-206) , label(63776-206) , manufacture(63776-206) , pack(63776-206)
    Establishment
    NameAddressID/FEIBusiness Operations
    Les Importations Herbasante Inc243254612manufacture(63776-206)
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