Lioresal
Product Images NDC 58281-563

16 FDA label images from Medtronic Neuromodulation · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 16 technical images submitted to the FDA as part of the official labeling for Lioresal (NDC 58281-563). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Medtronic Neuromodulation, 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

Structural Formula (Lioresalintrathecal 01)

Structural Formula (Lioresalintrathecal 01)
Chemical structure of the active ingredient, showing a chlorinated benzene ring with an aminoethyl side chain and a carboxyl group, consistent with baclofen, the active component of Lioresal.*
FDA Label Image

Carton For 1 Ampule 0.05 mg In 1 mL (Lioresalintrathecal Carton005 In 1ml 1ampule)

Carton For 1 Ampule 0.05 mg In 1 mL (Lioresalintrathecal Carton005 In 1ml 1ampule)
Lioresal Intrathecal baclofen injection 0.05 mg per 1 mL (50 mcg/mL) sterile solution in a 1 mL ampule. The label displays the Medtronic logo and indicates the product is for intrathecal injection only. The NDC 58281-562-01 is shown along with lot and expiration date fields.*
FDA Label Image

Carton For 1 Ampule 10 mg In 20 mL (Lioresalintrathecal Carton10 In 5ml 2ampules)

Carton For 1 Ampule 10 mg In 20 mL (Lioresalintrathecal Carton10 In 5ml 2ampules)
Lioresal Intrathecal baclofen injection 10 mg/5 mL sterile solution for intrathecal injection only. The label shows two 5 mL ampules, manufactured by Novartis Pharma Stein AG for Medtronic Neuromodulation. It includes warnings against use if ampule contains precipitate and advises referring to the package insert for dosage information.*
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Carton For 1 Ampule 10 mg In 20 mL (Lioresalintrathecal Kit Label10 In5)

Carton For 1 Ampule 10 mg In 20 mL (Lioresalintrathecal Kit Label10 In5)
Lioresal Intrathecal 10 mg/5 mL (2000 mcg/mL) baclofen injection refill kit label by Medtronic Neuromodulation. The refill kit is for use with SynchroMed Infusion Systems and includes two 5-mL Lioresal Intrathecal ampules, a 20-mL syringe, extension set, needles, filter, accessories, and instructions. The total volume is 10 mL across two ampules. Additional label details include storage instructions, lot number, use-by date, and manufacturer information.*
FDA Label Image

Ampule Label 10 mg In 20 mL (Lioresalintrathecal Label0.05 In1)

Ampule Label 10 mg In 20 mL (Lioresalintrathecal Label0.05 In1)
Lioresal Intrathecal baclofen injection label showing a sterile solution with concentration 0.05 mg per 1 mL (50 mcg/mL). The label indicates Rx only and states it is manufactured by Novartis Pharma Stein AG for Medtronic, Inc., Minneapolis, MN.*
FDA Label Image

Ampule Label 40 mg In 20 mL (Lioresalintrathecal Label40 In20)

Ampule Label 40 mg In 20 mL (Lioresalintrathecal Label40 In20)
Lioresal Intrathecal baclofen injection label showing 40 mg/20 mL (2000 mcg/mL) sterile solution for intrathecal injection. The label indicates Rx only and lists Novartis Pharma Stein AG, Stein, Switzerland, as manufacturer for Medtronic, Inc., Minneapolis, MN.*
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Arrow (Arrow)

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Precautions Icon (Manual Caution Icon)

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Figure 1 (Manual Figure1)

Figure 1 (Manual Figure1)
An annotated X-ray image showing internal components of a device with labeled parts including the radiopaque identifier, the Medtronic symbol, and the model designator. The image appears to highlight specific markers within the device for identification purposes.*
FDA Label Image

Figure 2 (Manual Figure2)

Figure 2 (Manual Figure2)
An instructional illustration showing how to align refill templates with two types of Medtronic pumps: the SynchroMed EL Programmable Pump on the left and the SynchroMed II Pump on the right. Each pump is depicted above its corresponding refill template, with alignment instructions indicated by arrows and text guiding the user to match the left or right edge of the template with the respective pump edge.*
FDA Label Image

Figure 3 (Manual Figure3)

Figure 3 (Manual Figure3)
A labeled medical diagram illustrating a subcutaneous implantable device with a reservoir fill port. The image shows a needle inserted through the septum into the bottom of the reservoir fill port, beneath subcutaneous tissue.*
FDA Label Image

Figure 4 (Manual Figure4)

Figure 4 (Manual Figure4)
An instructional diagram showing components for administration of Lioresal. Labels identify an empty syringe attached to a closed clamp, which connects to an extension set and needle. The needle is positioned through a template to access a reservoir fill port.*
FDA Label Image

Figure 5 (Manual Figure5)

Figure 5 (Manual Figure5)
An illustration diagram showing the assembly process for a medical device involving a syringe containing prescribed fluid connected to a filter, an open clamp, and a template leading to a reservoir fill port. Each component is labeled to guide the filling procedure, associated with the product Lioresal by Medtronic Neuromodulation.*
FDA Label Image

Figure 6 (Manual Figure6)

Figure 6 (Manual Figure6)
An instructional diagram showing a subcutaneous implantable reservoir device labeled with parts including the needle, septum, bottom of the reservoir fill port, and surrounding subcutaneous tissue. The illustration depicts the needle entering the reservoir through the septum under the skin.*
FDA Label Image

Symbol (Manual Sample Icon)

Symbol (Manual Sample Icon)
An instructional illustration depicting a hand gripping and pulling a curved surface, possibly indicating how to open or manipulate a part of the Lioresal product packaging or device.*
FDA Label Image

Warning Icon (Manual Warning Icon)

* 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.