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
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Contains inactivated NDC Code(s)
NDC Code(s): 63776-523-11, 63776-523-14, 63776-523-15, 63776-523-16, view more63776-523-17, 63776-523-18, 63776-523-19 - Packager: VIATREXX BIO INCORPORATED
- 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
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
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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).
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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
ZincDrainage
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
- Uses
- Warnings
- Dosage
- Keep this and all medicines out of reach of children.
- Inactive Ingredients
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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 sprayProduct 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)