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  4. NDC Product Code: 49823-200 Zuragard Clear

NDC 49823-200 Zuragard Clear

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 49823-200?
  4. Zuragard Clear Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Get all the details for National Drug Code (NDC) 49823-200 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
49823-200
Proprietary Name:
Zuragard Clear
Product Type: [3]
Labeler Name: [5]
Zurex Pharma, Inc.
Labeler Code:
49823
Product Label ID:
f513404d-d6f3-4ce2-9576-db96bb634e29
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
End Marketing Date: [10]
12-06-2024
Listing Expiration Date: [11]
12-06-2024
Exclude Flag: [12]
D
Code Navigator:

Code Structure Chart

Product Details

What is NDC 49823-200?

The NDC code 49823-200 is assigned by the FDA to the product Zuragard Clear which is product labeled by Zurex Pharma, Inc.. The product's dosage form is . The product is distributed in 2 packages with assigned NDC codes 49823-200-01 25 pouch in 1 carton / 10.5 ml in 1 pouch, 49823-200-02 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 Clear?

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

Which are Zuragard Clear UNII Codes?

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

Which are Zuragard Clear 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:

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Product Footnotes

[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.

[10] What is the End Marketing Date? - This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

[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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".