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  4. NDC Product Code: 49823-100 Zuragard Blue

NDC 49823-100 Zuragard Blue

Isopropyl Alcohol Solution Topical - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 49823-100?
  4. Zuragard Blue Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk

Product Information

NDC Product Code:
49823-100
Proprietary Name:
Zuragard Blue
Non-Proprietary Name: [1]
Isopropyl Alcohol
Substance Name: [2]
Isopropyl Alcohol
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
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]
    Zurex Pharma, Inc.
    Labeler Code:
    49823
    Product Label ID:
    a1a966b0-7e40-4d83-bcf9-dac0f43112da
    FDA Application Number: [6]
    NDA210872
    Marketing Category: [8]
    NDA - A product marketed under an approved New Drug Application.
    Start Marketing Date: [9]
    02-27-2023
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
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    Product Details

    What is NDC 49823-100?

    The NDC code 49823-100 is assigned by the FDA to the product Zuragard Blue which is a human over the counter drug product labeled by Zurex Pharma, Inc.. The generic name of Zuragard Blue is isopropyl alcohol. The product's dosage form is solution and is administered via topical form. The product is distributed in 2 packages with assigned NDC codes 49823-100-01 25 pouch in 1 carton / 10.5 ml in 1 pouch, 49823-100-02 25 pouch in 1 box / 26 ml in 1 pouch. 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 Zuragard Blue?

    Follow all directions for use▪use with care in premature infants or infants under 2 months of age.These products may cause irritation or chemical burns.▪do not use when the sponge is already wet upon opening the package▪discard the applicator after a single use along with any portion of thesolution which is not required to cover the prepped area. It is notnecessary to use the entire amount available.Getting Patient Ready for Solution:▪use in well-ventilated area▪do not microwave or heat the solution applicator▪apply to clean, completely dry, residue-free, intact skin▪when hair removal is necessary, use a surgical clipper on the morning ofthe surgery. If a wet shave is used, thoroughly remove all soap residues.Activating the Applicator:▪remove applicator from package; do not touch sponge▪hold the applicator with the sponge down. Depress the end cap/buttonto release the antiseptic, solution will flow into the sponge.When Applying Solution:▪completely wet the treatment area with antiseptic▪dry surgical sites (such as the abdomen or arm):use repeated back-and-forth strokes for 30 seconds▪moist surgical sites (such as inguinal fold):use repeated back-and-forth strokes for 2 minutes▪maximal treatment area for one applicator is approximately 8.4 in. x 8.4 in.(457 cm2)▪do not allow solution to pool; tuck prep towels to absorb solution, andthen remove▪avoid getting solution into hairy areas. Wet hair is flammable. Hair maytake up to 1 hour to dry.After Applying Solution:▪to reduce the risk of fire, wait until solution is completely dry(minimum of 3 minutes on hairless skin; up to 1 hour in hair)While Waiting for Solution to Completely Dry:▪do not drape or use ignition source (e.g., cautery laser)▪check for pooled solution. Use sterile gauze to soak up pooled solution.Do not blot or wipe away because it may remove solution from skin.▪remove wet materials from prep area. Replace if necessary.After Solution is Completely Dry:▪to reduce the risk of fire, begin draping and/or using cautery only aftersolution is completely dry and all wet materials are removed▪if incise drapes are used, apply directly to dry prep▪apply dressing following standard practices

    What are Zuragard Blue 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.

    Which are Zuragard Blue UNII Codes?

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

    Which are Zuragard Blue 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 Zuragard Blue?

    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:

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    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".