Skin Antisepsis, Oral Cleansing And Nasal Antisepsis System
NDC 53462-110

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 53462-110?
  4. Skin Antisepsis, Oral Cleansing And Nasal Antisepsis System Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Skin Antisepsis, Oral Cleansing And Nasal Antisepsis System is a NDA-approved product labeled by Sage Products, Llc. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a product. This product entry covers the primary NDC 53462-110 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
53462-110
Proprietary Name:
Skin Antisepsis, Oral Cleansing And Nasal Antisepsis System
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
Sage Products, Llc
Labeler Code:
53462
Product Label ID:
a12eefb3-1130-4644-895e-d219613d7e41
FDA Application Number: [6]
NDA021669
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
12-28-2016
Listing Expiration Date: [11]
12-31-2018
Exclude Flag: [12]
I

Code Structure Chart

Product Details

What is NDC 53462-110?

The NDC code 53462-110 is assigned by the FDA to the product Skin Antisepsis, Oral Cleansing And Nasal Antisepsis System. This pharmaceutical product is labeled by Sage Products, Llc and is currently categorized as listed product. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 53462-110-29. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

Before opening, turn package over, burst solution packet with thumbs. Peel lid to open.Brush teeth and oral cavity for approximately one minute.Instruct to expectorate.Use Applicator Swab for additional cleansing as needed.Discard after use.Use up to 4 times daily or as directed by a dentist or doctor.Children under 12 yeras of age: supervise use.Children under 3 years of age: consult a dentist or doctor.Use a bite block when performing oral care on patients with altered levels of consciousness or those who cannot comprehend commands.Ensure foam is intact after use. If not, remove any particles from oral cavity. use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.do not microwaveproduct and packaging are not sterile. Follow your hospital policy for skin preparation with non-sterile products.To open packageholding top of package in one hand, lift flap on backside of package with other handgrasp flap at top and pull down to tear flap away and expose foamhold outside of package to present foam and cloths to prep table, avoiding contact between cloths and outside of package to reduce risk of cloth contamination.Orusing sterile scissors, cut off end seal of packagetransfer contents onto prep table, avoiding contact between cloths and outside of package to reduce risk of cloth contaminationuse first cloth to prepare the skin area indicated for a moist or dry site, making certain to keep the second cloth where it will not be contaminated. Use second cloth to prepare larger areas.dry surgical sites (such as abdomen or arm): use one cloth to cleanse each 161 cm² area (approximately 5 x 5 inches) of skin to be prepared. Vigorously scrub skin back and forth for 3 minutes, completely wetting treatment area, then discard. Allow area to air dry for one (1) minute. Do not rinse. moist surgical sites (such as inguinal fold): use one cloth to cleanse each 65 cm² area (approximately 2 x 5 inches) of skin to be prepared. Vigorously scrub skin back and forth for 3 minutes, completely wetting treatment area, then discard. Allow area to air dry for one (1) minute. Do not rinse. discard each cloth after a single useafter package has been opened discard any unused cloths

Which are the associated UNII Codes?

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

Which are the Inactive Ingredients associated 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 this product?

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 & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
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.
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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
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.
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".