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Viatrexx Collagen

Generic name: pork collagen
Dosage form: injection

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

10ml
Rx
Sterile multi-dose injectable homeopathic vial
Isotonic saline with 1% Benzyl alcohol as a preservative.
For IV, IM, SC, Parenteral Use
Osmolarity around 0.3mOsmol/ml.

Description

Viatrexx-Collagen 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.

Indications and Use

Viatrexx-Collagen a sterile, injectable, biodegradable, clear isotonic liquid that is injected into the various layers of the skin, muscles, ligaments, joints, other body tissues or added to an IV, either as a push or into the bag.

Contraindications

This product should not be used in patients with a known hypersensitivity to any ingredient found in the formula, porcine products, isotonic saline or benzyl alcohol, or patients with a history of severe allergies. As with all injections, epinephrine injection (1:1,000) must be immediately available should an acute anaphylactoid reaction occur due to any component of the injection.

Warnings

Homeopathic injections are quite safe, but all medical procedures carry some risk. The most common risk is an allergic reaction to the injection of any ingredient found in the formula, porcine, benzyl alcohol &/or saline. Do not use if allergic to any of these substances. Side effects include some risk of bruising and temporary redness at the site of the injection. Use appropriate emergency protocol if signs of allergic reaction or infection appear, during or shortly after the injection.

Use in Obstetrics

This product contains 1% Benzyl Alcohol. Benzyl Alcohol has been reported to be associated with a fatal "Gasping Syndrome" in premature infants. Due to the benzyl alcohol content, this product should not be given to a pregnant woman.

Nursing Mothers

It is not known whether the benzyl alcohol or any of the ingredients is excreted in human milk. Caution should be exercised when products with benzyl alcohol are administered to nursing woman.

Use in Children

This product should not be used in patients with a known hypersensitivity to any ingredient in this formula, porcine products, isotonic saline or benzyl alcohol, or patients with a history of severe allergies. As with all injections, epinephrine injection (1:1,000) must be immediately available should an acute anaphylactoid reaction occur due to any component of the injection.

Techniques

May use any injection technique appropriate to the condition being addressed.

Dosage

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Viatrexx-Collagen is a clear, colorless solution. The product may be used directly as supplied. No dilution or reconstitution is necessary. 1% benzyl alcohol is included as a preservative. The quantity injected can vary between 0.1 ml through 10 ml, depending on the opinion of the practitioner and technique used. 0.2 ml per injection site is common. It is important to use a separate sterile needle and syringe free of preservatives, antiseptics and detergents, for each operation with the product and for each individual patient. Always use aseptic measures. Never introduce any foreign substance into the vial, if so then discard the vial. Never use expired product.

Use with other injectables

No adverse effects have been reported when combining with other Viatrexx injectables, stem cells, PRP, procaine or dextrose.

Over dosage

No over dosage has been reported with this product.

Storage

Store in a cool (50° to 68° F; 10° to 20° C) and dry place. Keep out of direct sunlight and heat. Discard 10 days after first puncture or sooner if signs of contamination are present. Refrigerate between 36° to 46° F / 2° to 8° C after first use. Always use aseptic measures. Do not use if tamper-evident seal is broken or removed. Discard the vial if the product has eclipsed the expiry date.

Product availability

Product may be acquired in 10 ml multi-dose vials in boxes of 1, 3, 6 or 12 vials.

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

Formula Ingredients Dilution Collagen 5C, 201K. These statements are for educational purposes only & have not been verified by any government authority or agency. This product is not intended to diagnosis, cure, treat, mitigate or heal any health condition

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 73069-095-42

Item: VSPC0085

Viatrexx Bio Incorporated

Viatrexx-Collagen© Rx

Box of 3 X 10 ml vials

Sterile multi-dose injectable

For IV, IM, SC, Parenteral Use

Preserved with Benzyl Alcohol

Osmolarity around 0.3mOsmol/ml.

Expiry date: Lot #:

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

Ingredients, homeopathic

See insert or www.viatrexx.com

Inactives: Benzyl Alcohol 1%, Isotonic saline

NDC: 73069-095-41

Item: VSPC0085

Viatrexx Bio Incorporated

Viatrexx-Collagen© Rx
Box of 1 X 10 ml vials

Sterile multi-dose injectable

For IV, IM, SC, Parenteral Use

Preserved with Benzyl Alcohol

Osmolarity around 0.3mOsmol/ml.

Expiry date: Lot #:

Manufactured for:
Viatrexx Bio Incorporated Newark, DE, USA, 19713
www.Viatrexx.com
Ingredients, homeopathic
See insert or www.viatrexx.com

Inactives: Benzyl Alcohol 1%, Isotonic saline

NDC: 73069-095-43

Item: VSPC0085

Viatrexx Bio Incorporated

Viatrexx-Collagen© Rx
Box of 5 X 10 ml vials

Sterile multi-dose injectable

For IV, IM, SC, Parenteral Use

Preserved with Benzyl Alcohol

Osmolarity around 0.3mOsmol/ml.

Expiry date: Lot #:

Manufactured for:
Viatrexx Bio Incorporated Newark, DE, USA, 19713
www.Viatrexx.com
Ingredients, homeopathic
See insert or www.viatrexx.com

Inactives: Benzyl Alcohol 1%, Isotonic saline

NDC: 73069-095-44

Item: VSPC0085

Viatrexx Bio Incorporated

Viatrexx-Collagen© Rx
Box of 6 X 10 ml vials

Sterile multi-dose injectable

For IV, IM, SC, Parenteral Use

Preserved with Benzyl Alcohol

Osmolarity around 0.3mOsmol/ml.

Expiry date: Lot #:

Manufactured for:
Viatrexx Bio Incorporated Newark, DE, USA, 19713
www.Viatrexx.com
Ingredients, homeopathic
See insert or www.viatrexx.com

Inactives: Benzyl Alcohol 1%, Isotonic saline

NDC: 73069-095-45

Item: VSPC0085

Viatrexx Bio Incorporated

Viatrexx-Collagen© Rx
Box of 10 X 10 ml vials

Sterile multi-dose injectable

For IV, IM, SC, Parenteral Use

Preserved with Benzyl Alcohol

Osmolarity around 0.3mOsmol/ml.

Expiry date: Lot #:

Manufactured for:
Viatrexx Bio Incorporated Newark, DE, USA, 19713
www.Viatrexx.com
Ingredients, homeopathic
See insert or www.viatrexx.com

Inactives: Benzyl Alcohol 1%, Isotonic saline

NDC: 73069-095-46

Item: VSPC0085

Viatrexx Bio Incorporated

Viatrexx-Collagen© Rx
Box of 12 X 10 ml vials

Sterile multi-dose injectable

For IV, IM, SC, Parenteral Use

Preserved with Benzyl Alcohol

Osmolarity around 0.3mOsmol/ml.

Expiry date: Lot #:

Manufactured for:
Viatrexx Bio Incorporated Newark, DE, USA, 19713
www.Viatrexx.com
Ingredients, homeopathic
See insert or www.viatrexx.com

Inactives: Benzyl Alcohol 1%, Isotonic saline

NDC: 73069-095-47

Item: VSPC0085

Viatrexx Bio Incorporated

Viatrexx-Collagen© Rx
Box of 25 X 10 ml vials

Sterile multi-dose injectable

For IV, IM, SC, Parenteral Use

Preserved with Benzyl Alcohol

Osmolarity around 0.3mOsmol/ml.

Expiry date: Lot #:

Manufactured for:
Viatrexx Bio Incorporated Newark, DE, USA, 19713
www.Viatrexx.com
Ingredients, homeopathic
See insert or www.viatrexx.com

Inactives: Benzyl Alcohol 1%, Isotonic saline

NDC: 73069-095-48

Item: VSPC0085

Viatrexx Bio Incorporated

Viatrexx-Collagen© Rx
Box of 50 X 10 ml vials

Sterile multi-dose injectable

For IV, IM, SC, Parenteral Use

Preserved with Benzyl Alcohol

Osmolarity around 0.3mOsmol/ml.

Expiry date: Lot #:

Manufactured for:
Viatrexx Bio Incorporated Newark, DE, USA, 19713
www.Viatrexx.com
Ingredients, homeopathic
See insert or www.viatrexx.com

Inactives: Benzyl Alcohol 1%, Isotonic saline

NDC: 73069-095-49

Item: VSPC0085

Viatrexx Bio Incorporated

Viatrexx-Collagen© Rx
Box of 100 X 10 ml vials

Sterile multi-dose injectable

For IV, IM, SC, Parenteral Use
Preserved with Benzyl Alcohol

Osmolarity around 0.3mOsmol/ml.

Expiry date: Lot #:

Manufactured for:
Viatrexx Bio Incorporated Newark, DE, USA, 19713
www.Viatrexx.com
Ingredients, homeopathic
See insert or www.viatrexx.com

Inactives: Benzyl Alcohol 1%, Isotonic saline

VIATREXX-COLLAGEN
pork collagen injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:73069-095
Route of Administration INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, PARENTERAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Pork Collagen (Pork Collagen) Pork Collagen 201 [kp_C] in 1 mL
Inactive Ingredients
Ingredient Name Strength
Benzyl Alcohol
Sodium Chloride
Water
Packaging
# Item Code Package Description
1 NDC:73069-095-41 1 VIAL, MULTI-DOSE in 1 BOX
1 10 mL in 1 VIAL, MULTI-DOSE
2 NDC:73069-095-42 3 VIAL, MULTI-DOSE in 1 BOX
2 10 mL in 1 VIAL, MULTI-DOSE
3 NDC:73069-095-44 6 VIAL, MULTI-DOSE in 1 BOX
3 10 mL in 1 VIAL, MULTI-DOSE
4 NDC:73069-095-46 12 VIAL, MULTI-DOSE in 1 BOX
4 10 mL in 1 VIAL, MULTI-DOSE
5 NDC:73069-095-43 5 VIAL, MULTI-DOSE in 1 BOX
5 10 mL in 1 VIAL, MULTI-DOSE
6 NDC:73069-095-45 10 VIAL, MULTI-DOSE in 1 BOX
6 10 mL in 1 VIAL, MULTI-DOSE
7 NDC:73069-095-47 25 VIAL, MULTI-DOSE in 1 BOX
7 10 mL in 1 VIAL, MULTI-DOSE
8 NDC:73069-095-21 1 VIAL, MULTI-DOSE in 1 BOX
8 2 mL in 1 VIAL, MULTI-DOSE
9 NDC:73069-095-22 3 VIAL, MULTI-DOSE in 1 BOX
9 2 mL in 1 VIAL, MULTI-DOSE
10 NDC:73069-095-23 5 VIAL, MULTI-DOSE in 1 BOX
10 2 mL in 1 VIAL, MULTI-DOSE
11 NDC:73069-095-24 6 VIAL, MULTI-DOSE in 1 BOX
11 2 mL in 1 VIAL, MULTI-DOSE
12 NDC:73069-095-25 10 VIAL, MULTI-DOSE in 1 BOX
12 2 mL in 1 VIAL, MULTI-DOSE
13 NDC:73069-095-26 12 VIAL, MULTI-DOSE in 1 BOX
13 2 mL in 1 VIAL, MULTI-DOSE
14 NDC:73069-095-27 25 VIAL, MULTI-DOSE in 1 BOX
14 2 mL in 1 VIAL, MULTI-DOSE
15 NDC:73069-095-28 50 VIAL, MULTI-DOSE in 1 BOX
15 2 mL in 1 VIAL, MULTI-DOSE
16 NDC:73069-095-29 100 VIAL, MULTI-DOSE in 1 BOX
16 2 mL in 1 VIAL, MULTI-DOSE
17 NDC:73069-095-48 50 VIAL, MULTI-DOSE in 1 BOX
17 10 mL in 1 VIAL, MULTI-DOSE
18 NDC:73069-095-49 100 VIAL, MULTI-DOSE in 1 BOX
18 10 mL in 1 VIAL, MULTI-DOSE
19 NDC:73069-095-11 1 VIAL, MULTI-DOSE in 1 BOX
19 1 mL in 1 VIAL, MULTI-DOSE
20 NDC:73069-095-12 3 VIAL, MULTI-DOSE in 1 BOX
20 1 mL in 1 VIAL, MULTI-DOSE
21 NDC:73069-095-13 5 VIAL, MULTI-DOSE in 1 BOX
21 1 mL in 1 VIAL, MULTI-DOSE
22 NDC:73069-095-14 6 VIAL, MULTI-DOSE in 1 BOX
22 1 mL in 1 VIAL, MULTI-DOSE
23 NDC:73069-095-15 10 VIAL, MULTI-DOSE in 1 BOX
23 1 mL in 1 VIAL, MULTI-DOSE
24 NDC:73069-095-16 12 VIAL, MULTI-DOSE in 1 BOX
24 1 mL in 1 VIAL, MULTI-DOSE
25 NDC:73069-095-17 25 VIAL, MULTI-DOSE in 1 BOX
25 1 mL in 1 VIAL, MULTI-DOSE
26 NDC:73069-095-18 50 VIAL, MULTI-DOSE in 1 BOX
26 1 mL in 1 VIAL, MULTI-DOSE
27 NDC:73069-095-19 100 VIAL, MULTI-DOSE in 1 BOX
27 1 mL in 1 VIAL, MULTI-DOSE
28 NDC:73069-095-31 1 VIAL, MULTI-DOSE in 1 BOX
28 5 mL in 1 VIAL, MULTI-DOSE
29 NDC:73069-095-32 3 VIAL, MULTI-DOSE in 1 BOX
29 5 mL in 1 VIAL, MULTI-DOSE
30 NDC:73069-095-33 5 VIAL, MULTI-DOSE in 1 BOX
30 5 mL in 1 VIAL, MULTI-DOSE
31 NDC:73069-095-34 6 VIAL, MULTI-DOSE in 1 BOX
31 5 mL in 1 VIAL, MULTI-DOSE
32 NDC:73069-095-35 10 VIAL, MULTI-DOSE in 1 BOX
32 5 mL in 1 VIAL, MULTI-DOSE
33 NDC:73069-095-36 12 VIAL, MULTI-DOSE in 1 BOX
33 5 mL in 1 VIAL, MULTI-DOSE
34 NDC:73069-095-37 25 VIAL, MULTI-DOSE in 1 BOX
34 5 mL in 1 VIAL, MULTI-DOSE
35 NDC:73069-095-38 50 VIAL, MULTI-DOSE in 1 BOX
35 5 mL in 1 VIAL, MULTI-DOSE
36 NDC:73069-095-39 100 VIAL, MULTI-DOSE in 1 BOX
36 5 mL in 1 VIAL, MULTI-DOSE
37 NDC:73069-095-51 1 VIAL, MULTI-DOSE in 1 BOX
37 20 mL in 1 VIAL, MULTI-DOSE
38 NDC:73069-095-52 3 VIAL, MULTI-DOSE in 1 BOX
38 20 mL in 1 VIAL, MULTI-DOSE
39 NDC:73069-095-53 5 VIAL, MULTI-DOSE in 1 BOX
39 20 mL in 1 VIAL, MULTI-DOSE
40 NDC:73069-095-54 6 VIAL, MULTI-DOSE in 1 BOX
40 20 mL in 1 VIAL, MULTI-DOSE
41 NDC:73069-095-55 10 VIAL, MULTI-DOSE in 1 BOX
41 20 mL in 1 VIAL, MULTI-DOSE
42 NDC:73069-095-56 12 VIAL, MULTI-DOSE in 1 BOX
42 20 mL in 1 VIAL, MULTI-DOSE
43 NDC:73069-095-57 25 VIAL, MULTI-DOSE in 1 BOX
43 20 mL in 1 VIAL, MULTI-DOSE
44 NDC:73069-095-58 50 VIAL, MULTI-DOSE in 1 BOX
44 20 mL in 1 VIAL, MULTI-DOSE
45 NDC:73069-095-59 100 VIAL, MULTI-DOSE in 1 BOX
45 20 mL in 1 VIAL, MULTI-DOSE
46 NDC:73069-095-61 1 VIAL, MULTI-DOSE in 1 BOX
46 30 mL in 1 VIAL, MULTI-DOSE
47 NDC:73069-095-62 3 VIAL, MULTI-DOSE in 1 BOX
47 30 mL in 1 VIAL, MULTI-DOSE
48 NDC:73069-095-63 5 VIAL, MULTI-DOSE in 1 BOX
48 30 mL in 1 VIAL, MULTI-DOSE
49 NDC:73069-095-64 6 VIAL, MULTI-DOSE in 1 BOX
49 30 mL in 1 VIAL, MULTI-DOSE
50 NDC:73069-095-65 10 VIAL, MULTI-DOSE in 1 BOX
50 30 mL in 1 VIAL, MULTI-DOSE
51 NDC:73069-095-66 12 VIAL, MULTI-DOSE in 1 BOX
51 30 mL in 1 VIAL, MULTI-DOSE
52 NDC:73069-095-67 25 VIAL, MULTI-DOSE in 1 BOX
52 30 mL in 1 VIAL, MULTI-DOSE
53 NDC:73069-095-68 50 VIAL, MULTI-DOSE in 1 BOX
53 30 mL in 1 VIAL, MULTI-DOSE
54 NDC:73069-095-69 100 VIAL, MULTI-DOSE in 1 BOX
54 30 mL in 1 VIAL, MULTI-DOSE
55 NDC:73069-095-71 1 VIAL, MULTI-DOSE in 1 BOX
55 50 mL in 1 VIAL, MULTI-DOSE
56 NDC:73069-095-72 3 VIAL, MULTI-DOSE in 1 BOX
56 50 mL in 1 VIAL, MULTI-DOSE
57 NDC:73069-095-73 5 VIAL, MULTI-DOSE in 1 BOX
57 50 mL in 1 VIAL, MULTI-DOSE
58 NDC:73069-095-74 6 VIAL, MULTI-DOSE in 1 BOX
58 50 mL in 1 VIAL, MULTI-DOSE
59 NDC:73069-095-75 10 VIAL, MULTI-DOSE in 1 BOX
59 50 mL in 1 VIAL, MULTI-DOSE
60 NDC:73069-095-76 12 VIAL, MULTI-DOSE in 1 BOX
60 50 mL in 1 VIAL, MULTI-DOSE
61 NDC:73069-095-77 25 VIAL, MULTI-DOSE in 1 BOX
61 50 mL in 1 VIAL, MULTI-DOSE
62 NDC:73069-095-78 50 VIAL, MULTI-DOSE in 1 BOX
62 50 mL in 1 VIAL, MULTI-DOSE
63 NDC:73069-095-79 100 VIAL, MULTI-DOSE in 1 BOX
63 50 mL in 1 VIAL, MULTI-DOSE
64 NDC:73069-095-81 1 VIAL, MULTI-DOSE in 1 BOX
64 100 mL in 1 VIAL, MULTI-DOSE
65 NDC:73069-095-82 3 VIAL, MULTI-DOSE in 1 BOX
65 100 mL in 1 VIAL, MULTI-DOSE
66 NDC:73069-095-83 5 VIAL, MULTI-DOSE in 1 BOX
66 100 mL in 1 VIAL, MULTI-DOSE
67 NDC:73069-095-84 6 VIAL, MULTI-DOSE in 1 BOX
67 100 mL in 1 VIAL, MULTI-DOSE
68 NDC:73069-095-85 10 VIAL, MULTI-DOSE in 1 BOX
68 100 mL in 1 VIAL, MULTI-DOSE
69 NDC:73069-095-86 12 VIAL, MULTI-DOSE in 1 BOX
69 100 mL in 1 VIAL, MULTI-DOSE
70 NDC:73069-095-87 25 VIAL, MULTI-DOSE in 1 BOX
70 100 mL in 1 VIAL, MULTI-DOSE
71 NDC:73069-095-88 50 VIAL, MULTI-DOSE in 1 BOX
71 100 mL in 1 VIAL, MULTI-DOSE
72 NDC:73069-095-89 100 VIAL, MULTI-DOSE in 1 BOX
72 100 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 03/29/2019
Labeler - VIATREXX BIO INCORPORATED (078419880)
Establishment
Name Address ID/FEI Operations
8046255 Canada Inc 200651455 api manufacture(73069-095), label(73069-095), manufacture(73069-095), pack(73069-095), sterilize(73069-095)
VIATREXX BIO INCORPORATED