NDC 49823-200 Zuragard Clear
Isopropyl Alcohol Solution Topical

Product Information

What is NDC 49823-200?

The NDC code 49823-200 is assigned by the FDA to the product Zuragard Clear which is a human over the counter drug product labeled by Zurex Pharma, Inc.. The generic name of Zuragard Clear 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 49823-200-01 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, RxNorm crosswalk and the complete product label.

NDC Product Code49823-200
Proprietary Name 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.		Zuragard Clear
Non-Proprietary Name 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.		Isopropyl Alcohol
Substance Name 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.		Isopropyl Alcohol
Product Type 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.		Human Otc Drug
Dosage FormSolution - 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) 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.		Zurex Pharma, Inc.
Labeler Code49823
FDA Application Number 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.		NDA210872
Marketing Category 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.		NDA - A product marketed under an approved New Drug Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.		02-27-2023
Listing Expiration Date 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.		12-31-2023
Exclude Flag 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". 		N
NDC Code Structure

What are the uses for Zuragard Clear?


Product Packages

NDC Code 49823-200-01

Package Description: 25 POUCH in 1 CARTON / 10.5 mL in 1 POUCH

NDC Code 49823-200-02

Package Description: 25 POUCH in 1 BOX / 26 mL in 1 POUCH

Product Details

What are Zuragard Clear 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.

Zuragard Clear Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? 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:

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.

* Please review the disclaimer below.

Zuragard Clear Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Active Ingredient – 10.5 Ml Applicator



Isopropyl alcohol 70% v/v


Purpose – 10.5 Ml Applicator



Antiseptic


Uses – 10.5 Ml Applicator



  • ▪for preparation of the skin prior to surgery
  • ▪helps reduce bacteria that potentially can cause skin infection

Warnings – 10.5 Ml Applicator



For external use only. Flammable, keep away from fire or flame.
To reduce rise of fire, PREP CAREFULLY:

  • ▪solution contains alcohol and gives off flammable vapors
  • ▪avoid getting solution into hairy areas. Wet hair is flammable. Hair may take up to 1 hour to dry.
  • ▪do not drape or use ignition source (e.g., cautery, laser) until solution is completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair)
  • ▪do not allow solution to pool
  • ▪remove wet material from prep area

Do Not Use



  • ▪on patients allergic to isopropyl alcohol or any other ingredient in this product
  • ▪for lumbar puncture or in contact with the meninges
  • ▪on open skin wounds or as a general skin cleanser
    • ▪on patients allergic to isopropyl alcohol or any other ingredient in this product
    • ▪for lumbar puncture or in contact with the meninges
    • ▪on open skin wounds or as a general skin cleanser

When Using This Product



keep out of eyes, ears, and mouth. May cause serious or permanent injury if permitted to enter and remain. If contact occurs, rinse with cold water right away and contact a doctor.

keep out of eyes, ears, and mouth. May cause serious or permanent injury if permitted to enter and remain. If contact occurs, rinse with cold water right away and contact a doctor.


Stop Use And Ask A Doctor If



irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.


Keep Out Of Reach Of Children.



If swallowed, get medical help or contact a Poison Control Center right away.


Directions – 10.5 Ml Applicator



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 the
    solution which is not required to cover the prepped area. It is not
    necessary 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 of
      the 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/button
        to 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, and
          then remove
        • ▪avoid getting solution into hairy areas. Wet hair is flammable. Hair may
          take 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 after
                solution is completely dry and all wet materials are removed
              • ▪if incise drapes are used, apply directly to dry prep
              • ▪apply dressing following standard practices

Other Information – 10.5 Ml Applicator



  • ▪store between 15-30oC (59-86oF)
  • ▪avoid freezing and excess heat above 40oC (104oF)

Inactive Ingredients – 10.5 Ml Applicator



citric acid, methylparaben, propylparaben, purified water USP, trisodium citrate


Questions? – 10.5 Ml Applicator



call 1-833-342-2798 (M-F 8AM-5PM CST).
www.zurexpharma.com


Active Ingredient – 26 Ml Applicator



Isopropyl alcohol 70% v/v


Purpose – 26 Ml Applicator



Antiseptic


Uses – 26 Ml Applicator



  • ▪for preparation of the skin prior to surgery
  • ▪helps reduce bacteria that potentially can cause skin infection

Warnings – 26 Ml Applicator



For external use only. Flammable, keep away from fire or flame.
To reduce rise of fire, PREP CAREFULLY:

  • ▪do not use 26-mL applicator for head and neck surgery
  • ▪do not use on an area smaller than 8.4 in x 8.4 in. Use a smaller applicator instead.
  • ▪solution contains alcohol and gives off flammable vapors
  • ▪avoid getting solution into hairy areas. Wet hair is flammable. Hair may take up to 1 hour to dry.
  • ▪do not drape or use ignition source (e.g., cautery, laser) until solution is completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair)
  • ▪do not allow solution to pool
  • ▪remove wet material from prep area

Keep Out Of Reach Of Children



If swallowed, get medical help or contact a Poison Control Center right away.


Directions – 26 Ml Applicator



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 the
    solution which is not required to cover the prepped area. It is not
    necessary 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 of
      the 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/button
        to 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 13.2 in. x 13.2 in.
          (1126 cm2)
        • ▪do not allow solution to pool; tuck prep towels to absorb solution, and
          then remove
        • ▪avoid getting solution into hairy areas. Wet hair is flammable. Hair may
          take 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 after
                solution is completely dry and all wet materials are removed
              • ▪if incise drapes are used, apply directly to dry prep
              • ▪apply dressing following standard practices

Other Information – 26 Ml Applicator



  • ▪store between 15-30oC (59-86oF)
  • ▪avoid freezing and excess heat above 40oC (104oF)

Inactive Ingredients – 26 Ml Applicator



citric acid, methylparaben, propylparaben, purified water USP, trisodium citrate


Questions? – 26 Ml Applicator



call 1-833-342-2798 (M-F 8AM-5PM CST) www.zurexpharma.com


Principal Display Panel – 10.5 Ml Applicator Label



Single Use
NDC 49823-200-01

ZuraGardTM
Isopropyl Alcohol (70% v/v) Solution
Patient Preoperative Skin Preparation

Non-sterile Solution
Applicator is sterile if package is intact
Surgical Solution
For head, neck, and small prep areas

CLEAR
10.5 mL (0.36 fl oz) APPLICATOR

 

Professional Use Only
Do not reuse
Not made with natural rubber latex

 

Warning
Flammable
Keep away from fire or flame.
To reduce risk of fire, PREP CAREFULLY:

  • ▪solution contains alcohol and gives
    off flammable vapors
  • ▪avoid getting solution into hairy
    areas. Wet hair is flammable. Hair
    may take up to 1 hour to dry.
  • ▪do not drape or use ignition source
    (e.g., cautery, laser) until solution is
    completely dry (minimum of 3
    minutes on hairless skin; up to 1
    hour in hair)
  • ▪do not allow solution to pool
  • ▪remove wet material from prep area

    •  
    Manufactured for
    Zurex Pharma, Inc.
    Middleton, WI 53562

    image-01 - image 01

    image-01 - image 01

    Label


Principal Display Panel – 26 Ml Applicator Label



Single Use
NDC 49823-200-02

ZuraGardTM
Isopropyl Alcohol (70% v/v) Solution
Patient Preoperative Skin Preparation

Non-sterile Solution
Applicator is sterile if package is intact
Surgical Solution
For large prep areas below the neck

CLEAR
26 mL (0.9 fl oz) APPLICATOR

 

Professional Use Only
Do not reuse
Not made with natural rubber latex

 

Warning
Flammable
Keep away from fire or flame.
To reduce risk of fire, PREP CAREFULLY:

  • ▪do not use 26-mL applicator for
    head and neck surgery, or on an
    area smaller than 8.4 in. x 8.4 in.
    Use a smaller applicator instead.
  • ▪solution contains alcohol and gives
    off flammable vapors
  • ▪avoid getting solution into hairy
    areas. Wet hair is flammable.
    Hair may take up to 1 hour to dry.
  • ▪do not drape or use ignition source
    (e.g., cautery, laser) until solution is
    completely dry (minimum of 3
    minutes on hairless skin; up to 1
    hour in hair)
  • ▪do not allow solution to pool
  • ▪remove wet material from prep area

    •  
    Manufactured for
    Zurex Pharma, Inc.
    Middleton, WI 53562

    image-02 - image 02

    image-02 - image 02

    Label


* Please review the disclaimer below.