NDC 73170-001 Tetraviv Advanced Cold Sore Care

2% Tetracaine

NDC Product Code 73170-001

NDC CODE: 73170-001

Proprietary Name: Tetraviv Advanced Cold Sore Care 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: 2% Tetracaine 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.

  • Mineral oil is used to treat constipation. It is known as a lubricant laxative. It works by keeping water in the stool and intestines. This helps to soften the stool and also makes it easier for stool to pass through the intestines. This medication should not be used in older adults, children younger than 6 years, or in people who are bedridden.

NDC Code Structure

  • 73170 - Credosano, Inc.

NDC 73170-001-22

Package Description: 2.2 g in 1 TUBE

NDC Product Information

Tetraviv Advanced Cold Sore Care with NDC 73170-001 is a a human over the counter drug product labeled by Credosano, Inc.. The generic name of Tetraviv Advanced Cold Sore Care is 2% tetracaine. The product's dosage form is gel and is administered via topical form.

Labeler Name: Credosano, Inc.

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

Product Type: Human Otc 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.

Tetraviv Advanced Cold Sore Care 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.

  • TETRACAINE 20 g/1000g
  • MINERAL OIL 784 g/1000g

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.

  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • PEPPERMINT OIL (UNII: AV092KU4JH)
  • HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
  • CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)

Administration Route(s)

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

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

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

Labeler Name: Credosano, Inc.
Labeler Code: 73170
FDA Application Number: part348 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 10-30-2019 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.

Tetraviv Advanced Cold Sore Care Product Label Images

Tetraviv Advanced Cold Sore Care 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

Warnings

For external use onlyWhen using this product do not get into the eyes or mucus membranesDo not apply over large surfaces of the body or use:   on deep puncture wounds   serious burns   or animal bites

Stop use and ask doctor if:   condition worsens or   symptoms last more than 7 days

Active Ingredients

Tetracaine 2%   Analgesic/Anesthetic and AntipuriticMineral oil 78.4%   Skin Protectant

Uses

Topically-applied medication for the temporary relief of pain and itching assocaitd wtih fever blisters and cold sores.Relieves dryness and softens cold sores and fever blistersSoftens crusts (scabs) associated with cold sores and fever blisters

Topically-applied medication for the temporary relief of pain and itching assocaitd wtih fever blisters and cold sores.Relieves dryness and softens cold sores and fever blistersSoftens crusts (scabs) associated with cold sores and fever blisters

Directions

Apply as needed and use only as directedWash hands before and after applicationClean the affected area and rubn in gently to disperseTreated area may be covered with a sterile bandageUse three times per day until healedDo not share this product with anyoneChildren under 3: ask a doctorIf swallowed, get medical help or contact a poison Control Center right away.

Keep Out Of Reach Of Children

Keep out of the reach of children.

Inactive Ingredients

Peppermint oil, polyethylene, propylene glycol, sodium carboxymethylcellulose

Questions

Manufactured for: Credo Sano 174 Nassau Street, Suite 336, Princeton, NJ 08542tetraviv.com888-803-3819

Other Information

Store product at room temperature 20C - 30C (68F-86F)Keep product in dark, dry place, if possible.

* Please review the disclaimer below.