VIATREXX-COLLAGEN- pork collagen injection

Viatrexx-Collagen by

Drug Labeling and Warnings

Viatrexx-Collagen by is a Prescription medication manufactured, distributed, or labeled by VIATREXX BIO INCORPORATED, 8046255 Canada Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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 

INGREDIENTS AND APPEARANCE

VIATREXX-COLLAGEN 
pork collagen injection

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 73069-095
Route of Administration	INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, PARENTERAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Pork Collagen (UNII: I8442U2G7J) (Pork Collagen - UNII:I8442U2G7J)	Pork Collagen	201 [kp_C]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Benzyl Alcohol (UNII: LKG8494WBH)
Sodium Chloride (UNII: 451W47IQ8X)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73069-095-41	1 in 1 BOX	05/05/2019
1		10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
2	NDC: 73069-095-42	3 in 1 BOX	05/05/2019
2		10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
3	NDC: 73069-095-44	6 in 1 BOX	05/05/2019
3		10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
4	NDC: 73069-095-46	12 in 1 BOX	05/05/2019
4		10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
5	NDC: 73069-095-43	5 in 1 BOX	05/06/2019
5		10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
6	NDC: 73069-095-45	10 in 1 BOX	05/06/2019
6		10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
7	NDC: 73069-095-47	25 in 1 BOX	05/06/2019
7		10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
8	NDC: 73069-095-21	1 in 1 BOX	05/06/2019
8		2 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
9	NDC: 73069-095-22	3 in 1 BOX	05/06/2019
9		2 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
10	NDC: 73069-095-23	5 in 1 BOX	05/06/2019
10		2 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
11	NDC: 73069-095-24	6 in 1 BOX	05/06/2019
11		2 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
12	NDC: 73069-095-25	10 in 1 BOX	05/06/2019
12		2 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
13	NDC: 73069-095-26	12 in 1 BOX	05/06/2019
13		2 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
14	NDC: 73069-095-27	25 in 1 BOX	05/06/2019
14		2 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
15	NDC: 73069-095-28	50 in 1 BOX	05/06/2019
15		2 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
16	NDC: 73069-095-29	100 in 1 BOX	05/06/2019
16		2 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
17	NDC: 73069-095-48	50 in 1 BOX	05/06/2019
17		10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
18	NDC: 73069-095-49	100 in 1 BOX	05/06/2019
18		10 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
19	NDC: 73069-095-11	1 in 1 BOX	05/06/2019
19		1 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
20	NDC: 73069-095-12	3 in 1 BOX	05/06/2019
20		1 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
21	NDC: 73069-095-13	5 in 1 BOX	05/06/2019
21		1 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
22	NDC: 73069-095-14	6 in 1 BOX	05/06/2019
22		1 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
23	NDC: 73069-095-15	10 in 1 BOX	05/06/2019
23		1 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
24	NDC: 73069-095-16	12 in 1 BOX	05/06/2019
24		1 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
25	NDC: 73069-095-17	25 in 1 BOX	05/06/2019
25		1 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
26	NDC: 73069-095-18	50 in 1 BOX	05/06/2019
26		1 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
27	NDC: 73069-095-19	100 in 1 BOX	05/06/2019
27		1 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
28	NDC: 73069-095-31	1 in 1 BOX	05/06/2019
28		5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
29	NDC: 73069-095-32	3 in 1 BOX	05/06/2019
29		5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
30	NDC: 73069-095-33	5 in 1 BOX	05/06/2019
30		5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
31	NDC: 73069-095-34	6 in 1 BOX	05/06/2019
31		5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
32	NDC: 73069-095-35	10 in 1 BOX	05/06/2019
32		5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
33	NDC: 73069-095-36	12 in 1 BOX	05/06/2019
33		5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
34	NDC: 73069-095-37	25 in 1 BOX	05/06/2019
34		5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
35	NDC: 73069-095-38	50 in 1 BOX	05/06/2019
35		5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
36	NDC: 73069-095-39	100 in 1 BOX	05/06/2019
36		5 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
37	NDC: 73069-095-51	1 in 1 BOX	05/06/2019
37		20 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
38	NDC: 73069-095-52	3 in 1 BOX	05/06/2019
38		20 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
39	NDC: 73069-095-53	5 in 1 BOX	05/06/2019
39		20 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
40	NDC: 73069-095-54	6 in 1 BOX	05/06/2019
40		20 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
41	NDC: 73069-095-55	10 in 1 BOX	05/06/2019
41		20 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
42	NDC: 73069-095-56	12 in 1 BOX	05/06/2019
42		20 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
43	NDC: 73069-095-57	25 in 1 BOX	05/06/2019
43		20 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
44	NDC: 73069-095-58	50 in 1 BOX	05/06/2019
44		20 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
45	NDC: 73069-095-59	100 in 1 BOX	05/06/2019
45		20 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
46	NDC: 73069-095-61	1 in 1 BOX	06/19/2019
46		30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
47	NDC: 73069-095-62	3 in 1 BOX	05/06/2019
47		30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
48	NDC: 73069-095-63	5 in 1 BOX	05/06/2019
48		30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
49	NDC: 73069-095-64	6 in 1 BOX	05/06/2019
49		30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
50	NDC: 73069-095-65	10 in 1 BOX	05/06/2019
50		30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
51	NDC: 73069-095-66	12 in 1 BOX	05/06/2019
51		30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
52	NDC: 73069-095-67	25 in 1 BOX	05/06/2019
52		30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
53	NDC: 73069-095-68	50 in 1 BOX	05/06/2019
53		30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
54	NDC: 73069-095-69	100 in 1 BOX	05/06/2019
54		30 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
55	NDC: 73069-095-71	1 in 1 BOX	05/06/2019
55		50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
56	NDC: 73069-095-72	3 in 1 BOX	05/06/2019
56		50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
57	NDC: 73069-095-73	5 in 1 BOX	05/06/2019
57		50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
58	NDC: 73069-095-74	6 in 1 BOX	05/06/2019
58		50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
59	NDC: 73069-095-75	10 in 1 BOX	05/06/2019
59		50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
60	NDC: 73069-095-76	12 in 1 BOX	05/06/2019
60		50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
61	NDC: 73069-095-77	25 in 1 BOX	05/06/2019
61		50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
62	NDC: 73069-095-78	50 in 1 BOX	05/06/2019
62		50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
63	NDC: 73069-095-79	100 in 1 BOX	05/06/2019
63		50 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
64	NDC: 73069-095-81	1 in 1 BOX	05/06/2019
64		100 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
65	NDC: 73069-095-82	3 in 1 BOX	05/06/2019
65		100 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
66	NDC: 73069-095-83	5 in 1 BOX	05/06/2019
66		100 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
67	NDC: 73069-095-84	6 in 1 BOX	05/06/2019
67		100 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
68	NDC: 73069-095-85	10 in 1 BOX	05/06/2019
68		100 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
69	NDC: 73069-095-86	12 in 1 BOX	05/06/2019
69		100 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
70	NDC: 73069-095-87	25 in 1 BOX	05/06/2019
70		100 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
71	NDC: 73069-095-88	50 in 1 BOX	05/06/2019
71		100 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
72	NDC: 73069-095-89	100 in 1 BOX	05/06/2019
72		100 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product

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	Business Operations
8046255 Canada Inc		200651455	api manufacture(73069-095) , label(73069-095) , manufacture(73069-095) , pack(73069-095) , sterilize(73069-095)