NDC 81489-001 Abrasa

Tetracycline Hydrochloride

NDC Product Code 81489-001

NDC 81489-001-01

Package Description: 29.5 mL in 1 BOTTLE, SPRAY

NDC Product Information

Abrasa with NDC 81489-001 is a a human over the counter drug product labeled by Azimuth Pharma, Llc. The generic name of Abrasa is tetracycline hydrochloride. The product's dosage form is spray and is administered via topical form.

Labeler Name: Azimuth Pharma, Llc

Dosage Form: Spray - A liquid minutely divided as by a jet of air or steam.

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.

Abrasa 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.

  • TETRACYCLINE HYDROCHLORIDE 30 mg/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.

  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • DIMETHYL SULFOXIDE (UNII: YOW8V9698H)
  • FULVIC ACID (UNII: XII14C5FXV)
  • WATER (UNII: 059QF0KO0R)
  • ZINC OXIDE (UNII: SOI2LOH54Z)

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.

Product Labeler Information

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

Labeler Name: Azimuth Pharma, Llc
Labeler Code: 81489
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: 01-30-2021 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 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.

Abrasa Product Label Images

Abrasa 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 hydrochloride 30 mg

Purpose

First aid Antibiotic

Use

  • First aid to help prevent skin infection in minor cuts, scrapes, and burns.

Warnings

For external use only

Do Not Use

  • In the eyes or apply over large areas of the bodyLonger than 1 week unless directed by a doctor

Ask A Doctor Before Use If

You have deep or puncture wounds, animal bites, or serious burns.

Stop Use And Ask 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 areaSpray a small amount of this product on the area 1 to 3 time dailyMay be covered with a sterile bandage

Other Information

  • Keep product refrigerated to preserve its effectiveness and colorStop use if product is misused: if the bottles is left open and/or if not refrigerated, the liquid will tend to turn black over time.Contains no alcohol, no animal ingredient.Blender for typical skin color.May stain cloth.

Inactive Ingredients

Citric Acid, Dimethyl Sulfoxide, Fulvic Acid, Water, Zinc Oxide

* Please review the disclaimer below.