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)

A letter from Baxter Healthcare Corporation providing important prescribing information dated November 13, 2024. It addresses the temporary importation of Sodium Chloride 0.9% for irrigation from the United Kingdom to mitigate drug shortages. The letter states that the FDA has not approved this product manufactured in Thetford, United Kingdom, and outlines regulatory conditions for its importation and distribution in the United States.*

FDA Label Image

Dhcp Letter 2 Of 7 (Image 02)

A table detailing an imported Baxter Healthcare Company product, Sodium Chloride 0.9% for Irrigation (UROMATIC), in a 3000 mL size with product code 3KB7127. The table notes packaging with 4 bags per carton and NDC code 0338-0110-01 for each bag. Additional text discusses inspection and compatibility guidelines during a specified period.*

FDA Label Image

Dhcp Letter 3 Of 7 (Image 03)

Text describing labeling notes for Sodium Chloride 0.9% Irrigation USP, including barcode absence on unit label for the imported product, prescription status differences, and references to product comparison tables for FDA-approved versus imported products.*

FDA Label Image

Dhcp Letter 4 Of 7 (Image 04)

This image shows a text panel providing instructions to refer to the FDA-approved prescribing information for 0.9% Sodium Chloride Irrigation USP. It includes detailed guidance on reporting adverse events or product quality issues related to this imported product, with contact information for Baxter Healthcare and FDA MedWatch reporting options, as well as ordering contact information.*

FDA Label Image

Dhcp Letter 5 Of 7 (Image 05)

FDA Label Image

Dhcp Letter 6 Of 7 (Image 06)

A product comparison table contrasting FDA-approved 0.9% Sodium Chloride Irrigation USP and imported UK 0.9% Sodium Chloride for Irrigation. It covers product name, label volume, label languages, indications, active ingredients, additional information, storage conditions, container types, and port closure images and descriptions for both products.*

FDA Label Image

Dhcp Letter 7 Of 7 (Image 07)

A comparison table showing label images for FDA-approved and imported Sodium Chloride 0.9% irrigation solutions. The FDA-approved label (left) uses black and red text, highlights 0.9% Sodium Chloride Irrigation USP with product details, manufacturer Baxter Healthcare Corporation (USA), and specifies cautions and usage instructions. The imported label (right) is fully red, lists Baxter Healthcare SA (Switzerland) as manufacturer, and provides product information in multiple languages including English, French, German, and Italian.*

FDA Label Image

Container Label Ndc 0338-0110 (Image 08)

Sodium Chloride 0.9% for irrigation, 3000 ml irrigant pouch by Baxter Healthcare Company. The label includes instructions and cautions in English, French, German, and Italian, specifying it is isotonic, pyrogen-free, and not for injection or use with bipolar electrodes. Contains batch lot and manufacturing details, with storage at 25°C and sterile indication.*

* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.