NDC 66715-5932 Circle K Triple Antibiotic

Bacitracin Zinc, Neomycin Sulfate And Polymyxin B Sulfate

NDC Product Code 66715-5932

NDC Code: 66715-5932

Proprietary Name: Circle K 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 And 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.


Code Structure
  • 66715 - Lil Drug Store Products, Inc
    • 66715-5932 - Circle K Triple Antibiotic

NDC 66715-5932-4

Package Description: 1 TUBE in 1 CARTON > 14.2 g in 1 TUBE

NDC Product Information

Circle K Triple Antibiotic with NDC 66715-5932 is a a human over the counter drug product labeled by Lil Drug Store Products, Inc. The generic name of Circle K Triple Antibiotic is bacitracin zinc, neomycin sulfate and polymyxin b sulfate. The product's dosage form is ointment and is administered via topical form.

Labeler Name: Lil Drug Store Products, Inc

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.


Circle K 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 [USP'U]/g
  • NEOMYCIN SULFATE 3.5 mg/g
  • POLYMYXIN B SULFATE 5000 [USP'U]/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.

  • COCOA BUTTER (UNII: 512OYT1CRR)
  • COTTONSEED OIL (UNII: H3E878020N)
  • OLIVE OIL (UNII: 6UYK2W1W1E)
  • SODIUM PYRUVATE (UNII: POD38AIF08)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • PETROLATUM (UNII: 4T6H12BN9U)

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: Lil Drug Store Products, Inc
Labeler Code: 66715
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: 02-12-2019 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.

Circle K Triple Antibiotic Product Label Images

Circle K 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

Otc - Active Ingredient

Active Ingredients (in each gram)Bacitracin Zinc         400 unitsNeomycin Sulfate      5 mg(3.5 mg of Neomycin base)Polymyxin-B Sulfate 5000 units

Otc - Purpose

PurposeFirst aid antibiotic

Indications & Usage

  • Usesfirst aid to help prevent infection inminor cutsscrapesburns

Warnings

WarningsFor external use only.

Otc - Do Not Use

  • Do not use in the eyesover large areas of the bodyif you are allergic to any of the ingredientslonger than 1 week unless directed by a doctor

Otc - Ask Doctor

Ask a doctor before use if you have deep or puncture wounds, animal bites, or serious burns

Otc - Stop Use

  • Stop use and ask a doctor ifthe condition persists or gets worsea rash or other allergic reaction develops

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

  • Directionsclean the affected area apply 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

Other

  • Other Informationstore at 20°C to 25°C (68°F to 77°C)do not use if tube seal under cap is broken, missing or if tube tip is cut prior to opening

Questions?call toll free 1-877-507-6516 (M-F-8AM-4:30PM CST)

Inactive Ingredient

Inactive Ingredients cocoa butter, cottonseed oil, olive oil, sodium pyruvate, vitamin E, white petrolatum

* Please review the disclaimer below.

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