NDC 10202-851 7 Select First Aid Triple Antibiotic

Bacitracin, Neomycin, And Polymyxin B

NDC Product Code 10202-851

NDC CODE: 10202-851

Proprietary Name: 7 Select 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, Neomycin, And Polymyxin B 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

  • 10202 - 7-eleven, Inc.
    • 10202-851 - 7 Select First Aid Triple Antibiotic

NDC 10202-851-14

Package Description: 1 TUBE in 1 BLISTER PACK > 14 g in 1 TUBE

NDC Product Information

7 Select First Aid Triple Antibiotic with NDC 10202-851 is a a human over the counter drug product labeled by 7-eleven, Inc.. The generic name of 7 Select First Aid Triple Antibiotic is bacitracin, neomycin, and polymyxin b. The product's dosage form is ointment and is administered via topical form. The RxNorm Crosswalk for this NDC code indicates a single RxCUI concept is associated to this product: 204602.

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.

7 Select 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.


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.

  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)

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: 7-eleven, Inc.
Labeler Code: 10202
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: 12-08-2016 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: 12-31-2021 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".

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Information for Patients

Neomycin, Polymyxin, and Bacitracin Topical

Neomycin, Polymyxin, and Bacitracin Topical is pronounced as (nee oh mye' sin) (pol i mix' in) (bass i tray' sin)

Why is neomycin, polymyxin, and bacitracin topical medication prescribed?
Neomycin, polymyxin, and bacitracin combination is used to prevent minor skin injuries such as cuts, scrapes, and burns from becoming infected. Neomycin, polymyxin, and b...
[Read More]

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7 Select First Aid Triple Antibiotic Product Label Images

7 Select 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

Otc - Active Ingredient

Active ingredients (in each gram)                                   PurposeBacitracin 400 units......................................................First aid antibioticNeomycin 3.5 mg.........................................................First aid antibioticPolymyxin B 5,000 units...............................................First aid antibiotic

Otc - Purpose

  • Use first aid to help prevent infection in minor:cutsscrapesburns

Warnings

WarningsFor external use only.

Otc - Do Not Use

  • Do not useif you are allergic to any of the ingredientsin the eyesover large areas of the body

Otc - Ask Doctor

  • Ask a doctor before use if you havedeep or puncture woundsanimal bitesserious burns

Otc - Stop Use

  • Stop use and ask a doctor ifyou need to use longer than 1 weekcondition persists or gets worserash 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.

Indications & Usage

  • Directionsclean 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

Storage And Handling

  • Other informationstore at 20° to 25°C (68° to 77°F)lot no. & exp. date: see packaging or see crimp of tube

Inactive Ingredient

Inactive ingredientsmethylparaben, mineral oil, petrolatum, polyoxyl 40 stearate, propylparaben

Dosage & Administration

DISTRIBUTED BY 7-ELEVEN, INC.Irving, TX 75063WWW.7-ELEVEN.COMMade in Korea

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