NDC 73069-410 Viatrexx-pigmentation

Adrenal, Azelaic, Copper, Cutis, Cysteine, Epithelial Gf, Fumaric Acid, Glutathione, Glycolic Acid, Kalium Aspariticum, Lymph Node, Melanine, Natrum Oxalaceticum, Natrum Pyruvicum, Phenylalanin, Quinhydrone, Succinic Acid, Thuja, Tyrosine, Vitamin C, Zinc

NDC Product Code 73069-410

NDC CODE: 73069-410

Proprietary Name: Viatrexx-pigmentation What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Adrenal, Azelaic, Copper, Cutis, Cysteine, Epithelial Gf, Fumaric Acid, Glutathione, Glycolic Acid, Kalium Aspariticum, Lymph Node, Melanine, Natrum Oxalaceticum, Natrum Pyruvicum, Phenylalanin, Quinhydrone, Succinic Acid, Thuja, Tyrosine, Vitamin C, Zinc What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to treat a certain skin condition called rosacea. It helps to reduce the number of inflamed skin lesions.
  • Drug uses not available
  • Drug uses not available
  • Drug uses not available
  • Drug uses not available

NDC Code Structure

NDC 73069-410-11

Package Description: 1 VIAL, MULTI-DOSE in 1 BOX > 1 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-12

Package Description: 3 VIAL, MULTI-DOSE in 1 BOX > 1 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-13

Package Description: 5 VIAL, MULTI-DOSE in 1 BOX > 1 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-14

Package Description: 6 VIAL, MULTI-DOSE in 1 BOX > 1 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-15

Package Description: 10 VIAL, MULTI-DOSE in 1 BOX > 1 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-16

Package Description: 12 VIAL, MULTI-DOSE in 1 BOX > 1 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-17

Package Description: 25 VIAL, MULTI-DOSE in 1 BOX > 1 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-18

Package Description: 50 VIAL, MULTI-DOSE in 1 BOX > 1 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-19

Package Description: 100 VIAL, MULTI-DOSE in 1 BOX > 1 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-21

Package Description: 1 VIAL, MULTI-DOSE in 1 BOX > 2 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-22

Package Description: 3 VIAL, MULTI-DOSE in 1 BOX > 2 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-23

Package Description: 5 VIAL, MULTI-DOSE in 1 BOX > 2 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-24

Package Description: 6 VIAL, MULTI-DOSE in 1 BOX > 2 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-25

Package Description: 10 VIAL, MULTI-DOSE in 1 BOX > 2 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-26

Package Description: 12 VIAL, MULTI-DOSE in 1 BOX > 2 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-27

Package Description: 25 VIAL, MULTI-DOSE in 1 BOX > 2 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-28

Package Description: 50 VIAL, MULTI-DOSE in 1 BOX > 2 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-29

Package Description: 100 VIAL, MULTI-DOSE in 1 BOX > 2 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-31

Package Description: 1 VIAL, MULTI-DOSE in 1 BOX > 5 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-32

Package Description: 3 VIAL, MULTI-DOSE in 1 BOX > 5 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-33

Package Description: 5 VIAL, MULTI-DOSE in 1 BOX > 5 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-34

Package Description: 6 VIAL, MULTI-DOSE in 1 BOX > 5 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-35

Package Description: 10 VIAL, MULTI-DOSE in 1 BOX > 5 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-36

Package Description: 12 VIAL, MULTI-DOSE in 1 BOX > 5 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-37

Package Description: 25 VIAL, MULTI-DOSE in 1 BOX > 5 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-38

Package Description: 50 VIAL, MULTI-DOSE in 1 BOX > 5 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-39

Package Description: 100 VIAL, MULTI-DOSE in 1 BOX > 5 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-41

Package Description: 1 VIAL, MULTI-DOSE in 1 BOX > 10 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-42

Package Description: 3 VIAL, MULTI-DOSE in 1 BOX > 10 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-43

Package Description: 5 VIAL, MULTI-DOSE in 1 BOX > 10 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-44

Package Description: 6 VIAL, MULTI-DOSE in 1 BOX > 10 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-45

Package Description: 10 VIAL, MULTI-DOSE in 1 BOX > 10 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-46

Package Description: 12 VIAL, MULTI-DOSE in 1 BOX > 10 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-47

Package Description: 25 VIAL, MULTI-DOSE in 1 BOX > 10 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-48

Package Description: 50 VIAL, MULTI-DOSE in 1 BOX > 10 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-49

Package Description: 100 VIAL, MULTI-DOSE in 1 BOX > 10 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-51

Package Description: 1 VIAL, MULTI-DOSE in 1 BOX > 20 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-52

Package Description: 3 VIAL, MULTI-DOSE in 1 BOX > 20 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-53

Package Description: 5 VIAL, MULTI-DOSE in 1 BOX > 20 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-54

Package Description: 6 VIAL, MULTI-DOSE in 1 BOX > 20 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-55

Package Description: 10 VIAL, MULTI-DOSE in 1 BOX > 20 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-56

Package Description: 12 VIAL, MULTI-DOSE in 1 BOX > 20 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-57

Package Description: 25 VIAL, MULTI-DOSE in 1 BOX > 20 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-58

Package Description: 50 VIAL, MULTI-DOSE in 1 BOX > 20 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-59

Package Description: 100 VIAL, MULTI-DOSE in 1 BOX > 20 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-61

Package Description: 1 VIAL, MULTI-DOSE in 1 BOX > 30 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-62

Package Description: 3 VIAL, MULTI-DOSE in 1 BOX > 30 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-63

Package Description: 5 VIAL, MULTI-DOSE in 1 BOX > 30 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-64

Package Description: 6 VIAL, MULTI-DOSE in 1 BOX > 30 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-65

Package Description: 10 VIAL, MULTI-DOSE in 1 BOX > 30 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-66

Package Description: 12 VIAL, MULTI-DOSE in 1 BOX > 30 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-67

Package Description: 25 VIAL, MULTI-DOSE in 1 BOX > 30 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-68

Package Description: 50 VIAL, MULTI-DOSE in 1 BOX > 30 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-69

Package Description: 100 VIAL, MULTI-DOSE in 1 BOX > 30 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-71

Package Description: 1 VIAL, MULTI-DOSE in 1 BOX > 50 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-72

Package Description: 3 VIAL, MULTI-DOSE in 1 BOX > 50 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-73

Package Description: 5 VIAL, MULTI-DOSE in 1 BOX > 50 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-74

Package Description: 6 VIAL, MULTI-DOSE in 1 BOX > 50 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-75

Package Description: 10 VIAL, MULTI-DOSE in 1 BOX > 50 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-76

Package Description: 12 VIAL, MULTI-DOSE in 1 BOX > 50 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-77

Package Description: 25 VIAL, MULTI-DOSE in 1 BOX > 50 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-78

Package Description: 50 VIAL, MULTI-DOSE in 1 BOX > 50 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-79

Package Description: 100 VIAL, MULTI-DOSE in 1 BOX > 50 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-81

Package Description: 1 VIAL, MULTI-DOSE in 1 BOX > 100 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-82

Package Description: 3 VIAL, MULTI-DOSE in 1 BOX > 100 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-83

Package Description: 5 VIAL, MULTI-DOSE in 1 BOX > 100 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-84

Package Description: 6 VIAL, MULTI-DOSE in 1 BOX > 100 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-85

Package Description: 10 VIAL, MULTI-DOSE in 1 BOX > 100 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-86

Package Description: 12 VIAL, MULTI-DOSE in 1 BOX > 100 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-87

Package Description: 25 VIAL, MULTI-DOSE in 1 BOX > 100 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-88

Package Description: 50 VIAL, MULTI-DOSE in 1 BOX > 100 mL in 1 VIAL, MULTI-DOSE

NDC 73069-410-89

Package Description: 100 VIAL, MULTI-DOSE in 1 BOX > 100 mL in 1 VIAL, MULTI-DOSE

NDC Product Information

Viatrexx-pigmentation with NDC 73069-410 is a a human prescription drug product labeled by Viatrexx Bio Incorporated. The generic name of Viatrexx-pigmentation is adrenal, azelaic, copper, cutis, cysteine, epithelial gf, fumaric acid, glutathione, glycolic acid, kalium aspariticum, lymph node, melanine, natrum oxalaceticum, natrum pyruvicum, phenylalanin, quinhydrone, succinic acid, thuja, tyrosine, vitamin c, zinc. The product's dosage form is injection and is administered via intramuscular; intravenous; parenteral; subcutaneous form.

Labeler Name: Viatrexx Bio Incorporated

Dosage Form: Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Viatrexx-pigmentation Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • SUS SCROFA ADRENAL GLAND 31 [kp_C]/mL
  • BOS TAURUS ADRENAL GLAND 31 [kp_C]/mL
  • AZELAIC ACID 31 [kp_C]/mL
  • BOS TAURUS SKIN 31 [kp_C]/mL
  • COPPER 201 [kp_C]/mL
  • CYSTEINE 31 [kp_C]/mL
  • FUMARIC ACID 31 [kp_C]/mL
  • GLUTATHIONE 201 [kp_C]/mL
  • GLYCOLIC ACID 31 [kp_C]/mL
  • POTASSIUM ASPARTATE 31 [kp_C]/mL
  • NEPIDERMIN 201 [kp_C]/mL
  • SUS SCROFA LYMPH VESSEL 201 [kp_C]/mL
  • BOS TAURUS LYMPH VESSEL 201 [kp_C]/mL
  • SODIUM DIETHYL OXALACETATE 31 [kp_C]/mL
  • SODIUM PYRUVATE 31 [kp_C]/mL
  • PHENYLALANINE 201 [kp_C]/mL
  • QUINHYDRONE 31 [kp_C]/mL
  • SUCCINIC ACID 31 [kp_C]/mL
  • THUJA OCCIDENTALIS LEAFY TWIG 31 [kp_C]/mL
  • TYROSINE 31 [kp_C]/mL
  • ASCORBIC ACID 31 [kp_C]/mL
  • ZINC 31 [kp_C]/mL
  • MELANIN SYNTHETIC (TYROSINE, PEROXIDE) 201 [kp_C]/mL
  • SUS SCROFA SKIN 31 [kp_C]/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
  • Parenteral - Administration by injection, infusion, or implantation.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
  • Parenteral - Administration by injection, infusion, or implantation.
  • Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Decreased Protein Synthesis - [PE] (Physiologic Effect)
  • Decreased Sebaceous Gland Activity - [PE] (Physiologic Effect)
  • Non-Standardized Animal Skin Allergenic Extract - [EPC] (Established Pharmacologic Class)
  • Increased Histamine Release - [PE] (Physiologic Effect)
  • Cell-mediated Immunity - [PE] (Physiologic Effect)
  • Increased IgG Production - [PE] (Physiologic Effect)
  • Cells -
  • Epidermal - [EXT]
  • Allergens - [CS]
  • Copper - [CS]
  • Copper-containing Intrauterine Device - [EPC] (Established Pharmacologic Class)
  • Decreased Embryonic Implantation - [PE] (Physiologic Effect)
  • Decreased Sperm Motility - [PE] (Physiologic Effect)
  • Inhibit Ovum Fertilization - [PE] (Physiologic Effect)
  • Melanin Synthesis Inhibitor - [EPC] (Established Pharmacologic Class)
  • Melanin Synthesis Inhibitors - [MoA] (Mechanism of Action)
  • Depigmenting Activity - [PE] (Physiologic Effect)
  • Vitamin C - [EPC] (Established Pharmacologic Class)
  • Ascorbic Acid - [CS]
  • Increased Histamine Release - [PE] (Physiologic Effect)
  • Cell-mediated Immunity - [PE] (Physiologic Effect)
  • Increased IgG Production - [PE] (Physiologic Effect)
  • Cells -
  • Epidermal - [EXT]
  • Allergens - [CS]
  • Non-Standardized Animal Skin Allergenic Extract - [EPC] (Established Pharmacologic Class)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Viatrexx Bio Incorporated
Labeler Code: 73069
Marketing Category: UNAPPROVED DRUG OTHER - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 03-29-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Viatrexx-pigmentation Product Label Images

Viatrexx-pigmentation Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

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-Pigmentation 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-Pigmentation 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-Pigmentation 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/medwatchDistributed by Viatrexx Bio Incorporated Newark, DE, USA, 19713Manufactured by 8046255 Canada Inc Beloeil, Qc, J3G 6S3 Date of last revision March 2019 For Questions and comments Info@Viatrexx.com www.Viatrexx.comFormula Ingredients Dilution Adrenal (31K), Azelaic (31K), Copper (201K), Cutis (31K), Cysteine (31K), Melanin Synthetic (201K) Fumaric acid (31K) Glutathione (201K), Glycolic acid (31K) Kalium aspariticum (31K) Lymph node (5C, 201K), Melanine (201K), Sodium Diethyl Oxalacetate (31K), Sodium Pyruvate (31K), Phenylalanin (201K), Quinhydrone (31K), Succinic acid (31K), Thuja (31K), Tyrosine (31K), Vitamin C (5C, 31K), Zinc (31K). 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

* Please review the disclaimer below.