Bactoshield Chg
NDC 0116-1322

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 0116-1322?
  5. Bactoshield Chg Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes

Product Information

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

Bactoshield Chg is a NDA-approved product labeled by Xttrium Laboratories, Inc.. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a yellow product. This product entry covers the primary NDC 0116-1322 and 4 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
0116-1322
Proprietary Name:
Bactoshield Chg
Product Type: [3]
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
Xttrium Laboratories, Inc.
Labeler Code:
0116
Product Label ID:
4a5483c2-10b7-0f08-e054-00144ff8d46c
FDA Application Number: [6]
NDA019422
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
10-04-1999
End Marketing Date: [10]
06-30-2021
Listing Expiration Date: [11]
06-30-2021
Exclude Flag: [12]
D

Product Characteristics

Color(s):
YELLOW (C48330 - CLEAR)

Code Structure Chart

Product Details

What is NDC 0116-1322?

The NDC code 0116-1322 is assigned by the FDA to the product Bactoshield Chg. This pharmaceutical product is labeled by Xttrium Laboratories, Inc. and is currently categorized as listed product. In terms of distribution, this product is available in 4 different package configurations. The associated package NDC(s) include: 0116-1322-03, 0116-1322-08, 0116-1322-24, 0116-1322-41. 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?

Use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.Surgical hand scrub: wet hands and forearms under running water for 30 seconds. Clean fingernails using a nailstick or similar cleaner.scrub for 1.5 minutes with about 8 mL of product with or without a wet brush paying close attention to the nails, cuticles, and skin between the fingers rinse thoroughly under the running water for 30 seconds wash for an additional 1.5 minutes with 8 mL of product and rinse under running water for 30 seconds dry thoroughly Healthcare personnel handwash: wet hands with water dispense about 5 mL of product into cupped hands and wash in a vigorous manner for 15 seconds rinse and dry thoroughly Patient preoperative skin preparation: apply product liberally to surgical site and swab for at least 2 minutes dry with a sterile towel repeat procedure for an additional 2 minutes and dry with a sterile towel Skin wound and general skin cleansing: thoroughly rinse the area to e cleaned with water apply the minimum amount of product necessary to cover the skin or wound area and wash gently rinse again thoroughly

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:

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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 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.
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".