Label: VIATREXX-TONE- calcarea fluorica, centella asiatica, copper, embryo, fumaric acid, funiculus, graphites, hamamelis, kalium aspariticum, muscle, natrum oxalaceticum, natrum pyruvicum, placenta, plasma, quinhydrone, silicea, succinic acid, vitamin b5, 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

    Calcarea fluorica (30K), Centella asiatica (6X, 30K), Cu (30K), Embryo (30K), Fumaric acid (30K), Funiculus (200K), Graphites (30K), Hamamelis (30K), Kalium aspariticum (30K), Muscle (6X, 200K), Natrum oxalaceticum (30K), Natrum pyruvicum (30K), Placenta (30K), Plasma (30K), Quinhydrone (30K), Silicea (30K), Succinic acid (30K), Vitamin B5 (30K), Zinc (30K). 

  • Purpose

    Calcarea fluorica 
    Centella asiatica
    Cu
    Embryo
    Fumaric acid
    Funiculus
    Graphites
    Hamamelis
    Kalium aspariticum
    Muscle
    Natrum oxalaceticum
    Natrum pyruvicum
    Placenta
    Plasma
    Quinhydrone
    Silicea
    Succinic acid
    Vitamin B5
    Zinc    		Drainage
    Adaptogen
    Metabolism
    Regeneration
    Cell respiration
    Regeneration
    Drainage
    Venous support
    Cell respiration
    Regeneration
    Cell respiration
    Cell respiration
    Regeneration
    Regeneration
    Metabolism
    Drainage
    Cell respiration
    Metabolism
    Neurological support
  • Description

    Viatrexx-Tone is a homeopathic product composed of physiological (low dose and low low dose) natural micro nutrients. These nano particles are designed to nourish the system.

  • Uses

    Soft tissue regeneration.

  • Warnings

    Stop use and ask a health care practitioner if symptoms persist for more than 5 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

    Alcohol 20% and Water 80%

  • Product availability

    Product may be acquired in 0.5, 30 ,50, 100, 250, 500 and 1,000 mL 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: 63776-523-11
    Item: VPC0678 

    Viatrexx Bio Incorporated

    Viatrexx-Tone  
    0.5 mL ampule     
    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: 63776-523-14
    Item: VPC0678 

    Viatrexx Bio Incorporated

    Viatrexx-Tone
    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: 63776-523-15
    Item: VPC0678 

    Viatrexx Bio Incorporated

    Viatrexx-Tone  
    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: 63776-523-16
    Item: VPC0678 

    Viatrexx Bio Incorporated

    Viatrexx-Tone  
    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: 63776-523-17
    Item: VPC0678 

    Viatrexx Bio Incorporated

    Viatrexx-Tone250 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%

  • INGREDIENTS AND APPEARANCE
    VIATREXX-TONE 
    calcarea fluorica, centella asiatica, copper, embryo, fumaric acid, funiculus, graphites, hamamelis, kalium aspariticum, muscle, natrum oxalaceticum, natrum pyruvicum, placenta, plasma, quinhydrone, silicea, succinic acid, vitamin b5, zinc spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63776-523
    Route of AdministrationORAL, TOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Calcium Fluoride (UNII: O3B55K4YKI) (Fluoride Ion - UNII:Q80VPU408O) Calcium Fluoride30 [kp_C]  in 1 mL
    Centella Asiatica (UNII: 7M867G6T1U) (Centella Asiatica - UNII:7M867G6T1U) Centella Asiatica30 [kp_C]  in 1 mL
    Copper (UNII: 789U1901C5) (Copper - UNII:789U1901C5) Copper30 [kp_C]  in 1 mL
    Sus Scrofa Embryo (UNII: 9928MC12VO) (Sus Scrofa Embryo - UNII:9928MC12VO) Sus Scrofa Embryo30 [kp_C]  in 1 mL
    Human Embryo Tissue (UNII: 8N9P319H5S) (Human Embryo Tissue - UNII:8N9P319H5S) Human Embryo Tissue30 [kp_C]  in 1 mL
    Fumaric Acid (UNII: 88XHZ13131) (Fumaric Acid - UNII:88XHZ13131) Fumaric Acid30 [kp_C]  in 1 mL
    Bos Taurus Umbilical Cord (UNII: E2LC2A33SN) (Bos Taurus Umbilical Cord - UNII:E2LC2A33SN) Bos Taurus Umbilical Cord200 [kp_C]  in 1 mL
    Sus Scrofa Umbilical Cord (UNII: 118OYG6W3H) (Sus Scrofa Umbilical Cord - UNII:118OYG6W3H) Sus Scrofa Umbilical Cord200 [kp_C]  in 1 mL
    Graphite (UNII: 4QQN74LH4O) (Graphite - UNII:4QQN74LH4O) Graphite30 [kp_C]  in 1 mL
    Witch Hazel (UNII: 101I4J0U34) (Witch Hazel - UNII:101I4J0U34) Witch Hazel30 [kp_C]  in 1 mL
    Potassium Aspartate (UNII: OC4598NZEQ) (Aspartic Acid - UNII:30KYC7MIAI) Potassium Aspartate30 [kp_C]  in 1 mL
    Pork (UNII: O138UB266J) (Pork - UNII:O138UB266J) Pork200 [kp_C]  in 1 mL
    Beef (UNII: 4PIB2155QP) (Beef - UNII:4PIB2155QP) Beef200 [kp_C]  in 1 mL
    Sodium Diethyl Oxalacetate (UNII: 6CA025Y4FG) (Diethyl Oxalacetate - UNII:15S56468G7) Sodium Diethyl Oxalacetate30 [kp_C]  in 1 mL
    Sodium Pyruvate (UNII: POD38AIF08) (Pyruvic Acid - UNII:8558G7RUTR) Sodium Pyruvate30 [kp_C]  in 1 mL
    Bos Taurus Placenta (UNII: 83AL37E3A7) (Bos Taurus Placenta - UNII:83AL37E3A7) Bos Taurus Placenta30 [kp_C]  in 1 mL
    Sus Scrofa Placenta (UNII: C8CV8867O8) (Sus Scrofa Placenta - UNII:C8CV8867O8) Sus Scrofa Placenta30 [kp_C]  in 1 mL
    Human Placental Tissue (UNII: QQF931PRWK) (Human Placental Tissue - UNII:QQF931PRWK) Human Placental Tissue30 [kp_C]  in 1 mL
    Human Plasma (UNII: T74K1VTI2X) (Human Plasma - UNII:T74K1VTI2X) Human Plasma30 [kp_C]  in 1 mL
    Quinhydrone (UNII: P4A66LQ3QJ) (Hydroquinone - UNII:XV74C1N1AE) Quinhydrone30 [kp_C]  in 1 mL
    Silicon Dioxide (UNII: ETJ7Z6XBU4) (Silicon Dioxide - UNII:ETJ7Z6XBU4) Silicon Dioxide30 [kp_C]  in 1 mL
    Succinic Acid (UNII: AB6MNQ6J6L) (Succinic Acid - UNII:AB6MNQ6J6L) Succinic Acid30 [kp_C]  in 1 mL
    Pantothenic Acid (UNII: 19F5HK2737) (Pantothenic Acid - UNII:19F5HK2737) Pantothenic Acid30 [kp_C]  in 1 mL
    Zinc (UNII: J41CSQ7QDS) (Zinc - UNII:J41CSQ7QDS) Zinc30 [kp_C]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Alcohol (UNII: 3K9958V90M)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63776-523-141 in 1 BOX07/18/2019
    130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    2NDC:63776-523-1550 mL in 1 BOTTLE; Type 0: Not a Combination Product07/18/2019
    3NDC:63776-523-110.5 mL in 1 AMPULE; Type 0: Not a Combination Product04/19/2021
    4NDC:63776-523-16100 mL in 1 BOTTLE; Type 0: Not a Combination Product04/19/2021
    5NDC:63776-523-17250 mL in 1 BOTTLE; Type 0: Not a Combination Product04/19/2021
    6NDC:63776-523-18500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/19/2021
    7NDC:63776-523-191000 mL in 1 BOTTLE; Type 0: Not a Combination Product04/19/2021
    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(63776-523) , label(63776-523) , manufacture(63776-523) , pack(63776-523)
    Establishment
    NameAddressID/FEIBusiness Operations
    Les Importations Herbasante Inc243254612manufacture(63776-523)
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