NDC 67091-272 Winco Maximum Strength Triple Antibiotic

Bacitracin Zinc,Neomycin Sulfate,Poymyxin B Sulfate,And Pramoxine Hydrochrloride Ointment - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
67091-272
Proprietary Name:
Winco Maximum Strength Triple Antibiotic
Non-Proprietary Name: [1]
Bacitracin Zinc, Neomycin Sulfate, Poymyxin B Sulfate, And Pramoxine Hydrochrloride
Substance Name: [2]
Bacitracin Zinc; Neomycin Sulfate; Polymyxin B Sulfate; Pramoxine Hydrochloride
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
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.
Administration Route(s): [4]
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Labeler Name: [5]
    Winco Foods, Llc
    Labeler Code:
    67091
    FDA Application Number: [6]
    part333B
    Marketing Category: [8]
    OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
    Start Marketing Date: [9]
    02-10-2015
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Packages

    NDC Code 67091-272-28

    Package Description: 1 TUBE in 1 CARTON / 28 g in 1 TUBE

    Product Details

    What is NDC 67091-272?

    The NDC code 67091-272 is assigned by the FDA to the product Winco Maximum Strength Triple Antibiotic which is a human over the counter drug product labeled by Winco Foods, Llc. The generic name of Winco Maximum Strength Triple Antibiotic is bacitracin zinc, neomycin sulfate, poymyxin b sulfate, and pramoxine hydrochrloride. The product's dosage form is ointment and is administered via topical form. The product is distributed in a single package with assigned NDC code 67091-272-28 1 tube in 1 carton / 28 g in 1 tube. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Winco Maximum Strength Triple Antibiotic?

    Directionsadults and children 2 years of age and older: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 bandagechildren under 2 years of age: ask a doctor

    What are Winco Maximum Strength Triple Antibiotic Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
    • BACITRACIN ZINC 500 [USP'U]/g - A complex of cyclic peptide antibiotics produced by the Tracy-I strain of Bacillus subtilis. The commercial preparation is a mixture of at least nine bacitracins with bacitracin A as the major constituent. It is used topically to treat open infections such as infected eczema and infected dermal ulcers. (From Goodman and Gilman, The Pharmacological Basis of Therapeutics, 8th ed, p1140)
    • NEOMYCIN SULFATE 3.5 mg/g - Aminoglycoside antibiotic complex produced by Streptomyces fradiae. It is composed of neomycins A, B, and C, and acts by inhibiting translation during protein synthesis.
    • POLYMYXIN B SULFATE 10000 [USP'U]/g - A mixture of polymyxins B1 and B2, obtained from BACILLUS POLYMYXA strains. They are basic polypeptides of about eight amino acids and have cationic detergent action on cell membranes. Polymyxin B is used for treatment of infections with gram-negative bacteria, but may be neurotoxic and nephrotoxic.
    • PRAMOXINE HYDROCHLORIDE 10 mg/g

    Which are Winco Maximum Strength Triple Antibiotic UNII Codes?

    The UNII codes for the active ingredients in this product are:

    Which are Winco Maximum Strength Triple Antibiotic Inactive Ingredients UNII Codes?

    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. The UNII codes for the inactive ingredients in this product are:

    What is the NDC to RxNorm Crosswalk for Winco Maximum Strength Triple Antibiotic?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
    • RxCUI: 1359350 - bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical Ointment
    • RxCUI: 1359350 - bacitracin 0.5 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG / pramoxine hydrochloride 0.01 MG/MG Topical Ointment

    Which are the Pharmacologic Classes for Winco Maximum Strength Triple Antibiotic?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

    * Please review the disclaimer below.

    Patient Education

    Neomycin, Polymyxin, and Bacitracin Topical


    Neomycin, polymyxin, and bacitracin combination is used to prevent minor skin injuries such as cuts, scrapes, and burns from becoming infected. Neomycin, polymyxin, and bacitracin are in a class of medications called antibiotics. Neomycin, polymyxin, and bacitracin combination works by stopping the growth of bacteria.
    [Learn More]


    Pramoxine


    Pramoxine is used to temporarily relieve pain and itching from insect bites; poison ivy, poison oak, or poison sumac; minor cuts, scrapes, or burns; minor skin irritation or rashes; or dry, itchy skin. Pramoxine also may be used to treat soreness, burning, itching, and pain from hemorrhoids (''piles'') and other minor rectal irritations or itching. Pramoxine is in a class of medications called topical anesthetics. It works by stopping nerves from sending pain signals.
    [Learn More]


    * Please review the disclaimer below.

    Product Footnotes

    [1] 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.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] 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.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

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

    [6] 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.

    [8] 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.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] 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.

    [12] 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".