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

Viatrexx-Tone by

Drug Labeling and Warnings

Viatrexx-Tone by is a Homeopathic medication manufactured, distributed, or labeled by VIATREXX BIO INCORPORATED, 8046255 Canada Inc, Les Importations Herbasante Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 asiaticaCuEmbryoFumaric acidFuniculusGraphitesHamamelisKalium aspariticumMuscleNatrum oxalaceticumNatrum pyruvicumPlacentaPlasmaQuinhydroneSiliceaSuccinic acidVitamin B5Zinc: 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%

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63776-523
Route of Administration	ORAL, TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Calcium Fluoride (UNII: O3B55K4YKI) (Fluoride Ion - UNII:Q80VPU408O)	Calcium Fluoride	30 [kp_C]  in 1 mL
Centella Asiatica (UNII: 7M867G6T1U) (Centella Asiatica - UNII:7M867G6T1U)	Centella Asiatica	30 [kp_C]  in 1 mL
Copper (UNII: 789U1901C5) (Copper - UNII:789U1901C5)	Copper	30 [kp_C]  in 1 mL
Sus Scrofa Embryo (UNII: 9928MC12VO) (Sus Scrofa Embryo - UNII:9928MC12VO)	Sus Scrofa Embryo	30 [kp_C]  in 1 mL
Human Embryo Tissue (UNII: 8N9P319H5S) (Human Embryo Tissue - UNII:8N9P319H5S)	Human Embryo Tissue	30 [kp_C]  in 1 mL
Fumaric Acid (UNII: 88XHZ13131) (Fumaric Acid - UNII:88XHZ13131)	Fumaric Acid	30 [kp_C]  in 1 mL
Bos Taurus Umbilical Cord (UNII: E2LC2A33SN) (Bos Taurus Umbilical Cord - UNII:E2LC2A33SN)	Bos Taurus Umbilical Cord	200 [kp_C]  in 1 mL
Sus Scrofa Umbilical Cord (UNII: 118OYG6W3H) (Sus Scrofa Umbilical Cord - UNII:118OYG6W3H)	Sus Scrofa Umbilical Cord	200 [kp_C]  in 1 mL
Graphite (UNII: 4QQN74LH4O) (Graphite - UNII:4QQN74LH4O)	Graphite	30 [kp_C]  in 1 mL
Witch Hazel (UNII: 101I4J0U34) (Witch Hazel - UNII:101I4J0U34)	Witch Hazel	30 [kp_C]  in 1 mL
Potassium Aspartate (UNII: OC4598NZEQ) (Aspartic Acid - UNII:30KYC7MIAI)	Potassium Aspartate	30 [kp_C]  in 1 mL
Pork (UNII: O138UB266J) (Pork - UNII:O138UB266J)	Pork	200 [kp_C]  in 1 mL
Beef (UNII: 4PIB2155QP) (Beef - UNII:4PIB2155QP)	Beef	200 [kp_C]  in 1 mL
Sodium Diethyl Oxalacetate (UNII: 6CA025Y4FG) (Diethyl Oxalacetate - UNII:15S56468G7)	Sodium Diethyl Oxalacetate	30 [kp_C]  in 1 mL
Sodium Pyruvate (UNII: POD38AIF08) (Pyruvic Acid - UNII:8558G7RUTR)	Sodium Pyruvate	30 [kp_C]  in 1 mL
Bos Taurus Placenta (UNII: 83AL37E3A7) (Bos Taurus Placenta - UNII:83AL37E3A7)	Bos Taurus Placenta	30 [kp_C]  in 1 mL
Sus Scrofa Placenta (UNII: C8CV8867O8) (Sus Scrofa Placenta - UNII:C8CV8867O8)	Sus Scrofa Placenta	30 [kp_C]  in 1 mL
Human Placental Tissue (UNII: QQF931PRWK) (Human Placental Tissue - UNII:QQF931PRWK)	Human Placental Tissue	30 [kp_C]  in 1 mL
Human Plasma (UNII: T74K1VTI2X) (Human Plasma - UNII:T74K1VTI2X)	Human Plasma	30 [kp_C]  in 1 mL
Quinhydrone (UNII: P4A66LQ3QJ) (Hydroquinone - UNII:XV74C1N1AE)	Quinhydrone	30 [kp_C]  in 1 mL
Silicon Dioxide (UNII: ETJ7Z6XBU4) (Silicon Dioxide - UNII:ETJ7Z6XBU4)	Silicon Dioxide	30 [kp_C]  in 1 mL
Succinic Acid (UNII: AB6MNQ6J6L) (Succinic Acid - UNII:AB6MNQ6J6L)	Succinic Acid	30 [kp_C]  in 1 mL
Pantothenic Acid (UNII: 19F5HK2737) (Pantothenic Acid - UNII:19F5HK2737)	Pantothenic Acid	30 [kp_C]  in 1 mL
Zinc (UNII: J41CSQ7QDS) (Zinc - UNII:J41CSQ7QDS)	Zinc	30 [kp_C]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Alcohol (UNII: 3K9958V90M)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63776-523-14	1 in 1 BOX	07/18/2019
1		30 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
2	NDC: 63776-523-15	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/18/2019
3	NDC: 63776-523-11	0.5 mL in 1 AMPULE; Type 0: Not a Combination Product	04/19/2021
4	NDC: 63776-523-16	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/19/2021
5	NDC: 63776-523-17	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/19/2021
6	NDC: 63776-523-18	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/19/2021
7	NDC: 63776-523-19	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/19/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		03/29/2019

Labeler - VIATREXX BIO INCORPORATED (078419880)

Establishment
Name	Address	ID/FEI	Business Operations
8046255 Canada Inc		200651455	api manufacture(63776-523) , label(63776-523) , manufacture(63776-523) , pack(63776-523)

Establishment
Name	Address	ID/FEI	Business Operations
Les Importations Herbasante Inc		243254612	manufacture(63776-523)