Sodium Chloride Irrigant
Product Images NDC 0338-0110

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Sodium Chloride (NDC 0338-0110). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Baxter Healthcare Company, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.

FDA Label Image

Dhcp Letter 1 Of 7 (Image 01)

This is a notice from Baxter Healthcare Corporation regarding the temporary importation of Sodium Chloride 0.9% for Irrigation from the United Kingdom to address drug shortages. The letter mentions the collaboration with the U.S. Food and Drug Administration (FDA) for this importation. It also highlights that only Baxter is authorized by the FDA for the import and distribution of this product in the United States. The letter advises healthcare professionals to pay attention to additional letters for information on other imported products.*

FDA Label Image

Dhcp Letter 2 Of 7 (Image 02)

This text announces that Baxter is offering an imported product, specifically Sodium Chloride 0.9% solution for irrigation under the UROMATIC brand. Before use, it is essential to visually inspect the bags for particulate matter and leaks to ensure container integrity and sterility. If any issues are detected, a new bag should be used. It is also stated that the product's port system is fully compatible with Baxter urology irrigation sets in the United States.*

FDA Label Image

Dhcp Letter 3 Of 7 (Image 03)

The text informs about the importance of ensuring correct product information in systems when a barcode is missing on an imported product label. It highlights the need for institutions to manually input data to avoid inconsistencies during scanning. The document also points out differences between FDA-approved 0.9% Sodium Chloride Irrigation USP and an imported version in terms of labeling, prescription status, and key details as outlined in comparison tables provided.*

FDA Label Image

Dhcp Letter 4 Of 7 (Image 04)

This text provides detailed information on how to report adverse events or product quality issues related to the FDA-approved drug product "0.9% Sodium Chloride Irrigation USP" by Baxter. It includes contact details for reporting adverse events to Baxter or the FDA's MedWatch program, as well as how to report product quality issues. Additionally, it offers a contact number for Baxter's Medical Information Service for any inquiries about the product and a separate number for placing orders through Baxter's Center for Service.*

FDA Label Image

Dhcp Letter 5 Of 7 (Image 05)

FDA Label Image

Dhcp Letter 6 Of 7 (Image 06)

This is a description of a comparison between two products of Sodium Chloride Irrigation solutions: FDA-approved 0.9% Sodium Chloride Irrigation USP and Imported Sodium Chloride 0.9% for Irrigation from the UK. The comparison includes details such as label information, language options, indications for use, active ingredients, storage instructions, and container specifications. The information provided highlights the key differences between these two products, serving as a guide for decision-making based on factors like composition, usage, and storage requirements.*

FDA Label Image

Dhcp Letter 7 Of 7 (Image 07)

This text provides a comparison between FDA-approved 0.9% Sodium Chloride Irrigation USP and Imported Sodium Chloride 0.9% for Irrigation. It includes details about the labeling colors, lack of information on lot numbers, and expiration dates for both products. The text also contains information about the products' lots, usage instructions, and some textual content related to the Sodium Chloride solutions. The data also mentions the manufacturer Baxter and provides a reference number. Additionally, it features information in different languages including French, German, Italian, and possibly another language.*

FDA Label Image

Container Label Ndc 0338-0110 (Image 08)

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.