NDC 44224-0013 Easy Care First Aid Triple Antibiotic

Bacitracin Zinc,neomycin Sulfate,polymyxin B Sulfate

NDC Product Code 44224-0013

NDC Code: 44224-0013

Proprietary Name: Easy Care First Aid Triple Antibiotic 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: Bacitracin Zinc,neomycin Sulfate,polymyxin B Sulfate 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.

NDC Code Structure

NDC 44224-0013-4

Package Description: .9 g in 1 TUBE

NDC 44224-0013-5

Package Description: 10 PACKET in 1 BOX > .9 g in 1 PACKET

NDC 44224-0013-6

Package Description: 100 PACKET in 1 CARTON > .9 g in 1 PACKET

NDC Product Information

Easy Care First Aid Triple Antibiotic with NDC 44224-0013 is a a human over the counter drug product labeled by Tender Corporation. The generic name of Easy Care First Aid Triple Antibiotic is bacitracin zinc,neomycin sulfate,polymyxin b sulfate. The product's dosage form is ointment and is administered via topical form.

Labeler Name: Tender Corporation

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.

Easy Care First Aid Triple Antibiotic 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.

  • BACITRACIN ZINC 400 [iU]/g
  • NEOMYCIN SULFATE 5 mg/g
  • POLYMYXIN B SULFATE 5000 [iU]/g

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.

  • PETROLATUM (UNII: 4T6H12BN9U)
  • MINERAL OIL (UNII: T5L8T28FGP)

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: Tender Corporation
Labeler Code: 44224
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: 09-01-2019 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.

Easy Care First Aid Triple Antibiotic 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 Ingredients

Bacitracin Zinc 400 unitsNeomycin Sulfate 5mg ( equivalent to 3.5 mg Neomycin base)Polymyxin B Sulfate 5000 units

Purpose

First Aid Antibiotic

Use

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

Warnings

For external use only.

Do Not Use

  • If you are allergic to any of the ingredientsin the eyesover large areas of the body

Ask A Doctor Before Use If You Have

  • Deep puncture woundsanimal bitesserious burns

Stop Use And Ask A Doctor If

Symptoms persist for more than 7 days or clear up and occur again within a few days.

Keep Out Of Reach Of Children

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

Directions

  • Adults and children 2 year of age and older: clean the affected area; apply a small amount to the area 1-3 times daily; may be covered with a sterile bandagechildren under 2 years of age: consult a doctor

Inactive Ingredients

Mineral oil, petrolatum

* Please review the disclaimer below.