Sodium Chloride Irrigant
Product Images NDC 0338-9834

Product Visual Gallery

This gallery contains 8 technical images submitted to the FDA as part of the official labeling for Sodium Chloride (NDC 0338-9834). 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 text provides important information about Baxter Healthcare Corporation temporarily importing 0.9% Sodium Chloride Irrigation, USP from Alliston, Canada to address drug shortages. Healthcare professionals are advised to read the letter in its entirety as it contains product-specific information. Only Baxter is authorized by the FDA to import or distribute this product in the United States during this temporary period.*

FDA Label Image

Dhcp Letter 2 Of 7 (Image 02)

Product name: 0.9% Sodium Chloride Irrigation, USP (UROMATIC) Size: 3,000 mL Product code: 1B7127 Bags per carton: 4 Description: This product is a single bag of 0.9% Sodium Chloride Irrigation, USP (UROMATIC) with a size of 3,000 mL. Please note that the imported products have a 2D barcode instead of a linear barcode on the bag, which may not register accurately in U.S. scanning systems. Institutions should follow alternative procedures to ensure the correct drug product is used and consider manually inputting the product into their systems. Barcodes containing the NDC number for each imported product will be available digitally.*

FDA Label Image

Dhcp Letter 3 Of 7 (Image 03)

This text provides information about the differences in labeling between the FDA-approved 0.9% Sodium Chloride Irrigation and the imported product. It highlights the key variations and also mentions the absence of the "Rx only" statement on the imported product's labeling. The text emphasizes the importance of using a new bag if particulates are visible or if there is a leak. Further details on these distinctions are likely outlined in the product comparison tables included at the end of the document.*

FDA Label Image

Dhcp Letter 4 Of 7 (Image 04)

This text provides important information regarding reporting adverse events or product quality issues related to the drug product "0.9% Sodium Chloride Irrigation, USP." It includes contact details for reporting adverse events to Baxter or FDA's MedWatch program, as well as instructions for reporting product quality issues. Additionally, it offers contact information for Baxter's Medical Information Service and Center for Service for inquiries or ordering. The signed message from Cecilia Soriano, President of Infusion Therapies & Technologies at Baxter Healthcare Corporation, concludes the communication.*

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Dhcp Letter 5 Of 7 (Image 05)

FDA Label Image

Dhcp Letter 6 Of 7 (Image 06)

This is a product comparison table detailing the differences between FDA-approved 0.9% Sodium Chloride Irrigation, USP and Imported 0.9% Sodium Chloride for Irrigation, USP. The table compares key aspects such as product details, volume, language on labels, indications for use, active ingredients, additional information, container type, and port closures. The products are intended for use as a urologic irrigating fluid during procedures requiring distension, irrigation, and lavage of the urinary bladder. Instructions for usage, storage, and handling are also provided. The document appears to be a comprehensive guide for comparing these two products.*

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 an imported product from Alliston, Canada, highlighting differences in labeling and information presentation. The table includes details such as label color, lot numbers, expiration dates, and specific product information. The text also mentions warnings such as "NOT FOR INJECTION / IRRIGATION ONLY" and includes additional cautionary language. This information could be helpful for individuals involved in pharmaceuticals, healthcare, or regulatory compliance to understand and compare these products.*

FDA Label Image

Container Label Ndc 0338-9834 (Image 08)

This is a description of a 3000 mL bag containing 0.9% Sodium Chloride Irrigation USP for medical purposes. The bag is labeled for irrigation use only, not for injection. It provides information on sodium chloride content, cautions for single use, storage instructions, and sterile handling precautions. The product is identified with a DIN number and manufactured by Baxter Corporation.*

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