NDC 79790-000 Tetracyte Topical

Tetracycline Hydrochloride Ointment Topical

  1. Labeler Index
  2. Wounds Pros, Llc
  3. NDC: 79790-000 Tetracyte Topical

NDC Product Code 79790-000

NDC CODE: 79790-000

Proprietary Name: Tetracyte Topical 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: Tetracycline Hydrochloride 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 product is used as first aid/antibiotic

NDC Code Structure

NDC 79790-000-00

Package Description: 1 BOTTLE in 1 BOX > 15 mL in 1 BOTTLE

NDC Product Information

Tetracyte Topical with NDC 79790-000 is a human over the counter drug product labeled by Wounds Pros, Llc. The generic name of Tetracyte Topical is tetracycline hydrochloride. The product's dosage form is ointment and is administered via topical form.

Dosage Form: Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Tetracyte Topical 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.

RxNorm Crosswalk

What is RxNorm?
RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) (RxCUI) to each NDC.

The RxNorm Crosswalk for this NDC code indicates a single concept unique identifier (RXCUI) is associated with this product:


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.
  • ACETIC ACID (UNII: Q40Q9N063P)
  • ASCORBIC ACID (UNII: PQ6CK8PD0R)
  • CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
  • CHOLECALCIFEROL (UNII: 1C6V77QF41)
  • DIMETHYL SULFOXIDE (UNII: YOW8V9698H)
  • DIPROPYLENE GLYCOL (UNII: E107L85C40)
  • GLUCONOLACTONE (UNII: WQ29KQ9POT)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HISTIDINE (UNII: 4QD397987E)
  • HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • SORBIC ACID (UNII: X045WJ989B)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • 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.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Pharmacologic Class(es)

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

Product Labeler Information

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

Labeler Name: Wounds Pros, Llc
Labeler Code: 79790
FDA Application Number: part333B 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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 07-01-2020 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Tetracyte Topical Product Label Images

Tetracyte Topical 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

Active Ingredient (In Each Gram)

Tetracycline-HCL 30mg

Purpose

First Aid/Antibiotic

Indications

First aid to help prevent the risk of skin infection in minor cuts, scrapes, or burns.

Warnings

For external use only. May be harmful if swallowed.Allergy AlertDo not use if allergic to any ingredient listed on this label.

Do Not Use

  • In eyes  over large areas of the body longer than 1 week unless directed by doctor

Ask A Doctor Before Use If You Have

  • Deep or puncture woundsanimal bitesserious trauma

Stop Use And Ask A Doctor

If condition persists or gets worse.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison control Center right away.

Directions

  • Clean the affected areaapply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times dailymay be covered with a sterile bandage

Stop Use If Product Is Misused

  • This product is an OTC antibiotic for human use contains no alcohol, no animal ingredientsblended for typical skin color may stain cloth no claims regarding stem cell healing are implied for this product

Other Information

  • For best results refrigerate or store in a cool dark place.

Inactive Ingredients

Acetic acid, ascorbic acid, chlorhexidine gluconate, cholecalciferol, dimethyl sulfoxide, dipropylene glycol, glucono delta lactone, glycerin, histidine, hydroxethyl-cellulose, magnesium stearate, sodium hydroxide, sorbic acid, stearic acid, water

* Please review the disclaimer below.