Xeomin Injection, Powder, Lyophilized, For Solution
Product Images NDC 46783-160

15 FDA label images from Merz North America, Inc. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 15 technical images submitted to the FDA as part of the official labeling for Xeomin (NDC 46783-160). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Merz North America, Inc., 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

Figure 1 (Xeomin 01)

Figure 1 (Xeomin 01)
An anatomical side-profile illustration of a man's head and neck showing the location of the parotid and submandibular glands. The parotid gland is labeled and situated near the ear, while the submandibular gland is labeled under the jaw. Surrounding muscles and landmarks are also depicted for reference.*
FDA Label Image

Figure 2 (Xeomin 02)

Figure 2 (Xeomin 02)
An anatomical illustration showing a side view of a child's head with detailed depiction of facial muscles and glands. The parotid gland and submandibular gland are labeled, highlighting their locations near the jaw and beneath the ear.*
FDA Label Image

Figure 3 (Xeomin 03)

Figure 3 (Xeomin 03)
An anatomical illustration showing the muscles of the human forearm and hand. Key muscles labeled include the biceps brachii, brachioradialis, pronator teres, various flexor muscles (carpi radialis, pollicis longus, digitorum superficialis and profundus, carpi ulnaris), brachialis, pronator quadratus, opponens pollicis, flexor pollicis brevis, and adductor pollicis. The illustration highlights muscle locations and their attachments on the skeletal structure of the forearm and hand.*
FDA Label Image

Figure 4 (Xeomin 04)

Figure 4 (Xeomin 04)
An anatomical diagram of the anterior upper limb showing labeled muscles and tendons including the biceps brachii, brachialis, brachioradialis, pronator teres, flexor carpi radialis, pronator quadratus, flexor carpi ulnaris, flexor digitorum superficialis, opponens pollicis, flexor pollicis, adductor pollicis, and distal tendons of the flexor digitorum profundus (muscle belly not visible).*
FDA Label Image

Figure 5 (Xeomin 05)

Figure 5 (Xeomin 05)
An anatomical illustration showing detailed musculature of the neck and upper back. The left side view highlights muscles including sternocleidomastoid, splenius capitis, levator scapula, scalenus anterior, and scalenus medius. The rear view labels muscles such as trapezius, semispinalis capitis, splenius capitis, and levator scapulae.*
FDA Label Image

Figure 6 (Xeomin 06)

Figure 6 (Xeomin 06)
An anatomical diagram showing the muscles around the forehead and eyes relevant to intramuscular injection sites. It highlights the corrugator muscle and sections of the orbicularis oculi muscle, including lateral and medial superior pre-tarsal parts, lateral canthus, and inferolateral portion, each labeled with corresponding letters and explanations.*
FDA Label Image

Principal Display Panel (50 units/vial Label)

Principal Display Panel (50 units/vial Label)
An anatomical illustration showing facial muscles relevant to intramuscular injection, including the corrugator, procerus, occipitofrontalis, and orbicularis oculi muscles. The diagram highlights muscle locations on the upper face with labels and black dots indicating specific injection sites.*
FDA Label Image

Principal Display Panel (- 50 units/vial Carton)

Principal Display Panel (- 50 units/vial Carton)
A bar chart comparing the percentage of patients treated with Xeomin versus placebo, showing changes in Global Impression of Change Scale (GICS) scores. The horizontal axis represents change in GICS from 'Very much worse' to 'Very much improved', and the vertical axis shows the percentage of patients. The chart highlights differences in patient outcomes between Xeomin and placebo groups across various improvement levels.*
FDA Label Image

Principal Display Panel (100 units/vial Label)

Principal Display Panel (100 units/vial Label)
A cumulative percentage of patients chart showing change from baseline on the TWSTRS (Toronto Western Spasmodic Torticollis Rating Scale) for treatment groups placebo, Xeomin 120 U, and Xeomin 240 U. The x-axis represents change from baseline on TWSTRS and the y-axis shows cumulative percentage of patients. The chart includes vertical lines marking changes at -28.5, -7, and 0, with corresponding patient response percentages listed for each group at these change points.*
FDA Label Image

Principal Display Panel (100 units/vial Carton)

Principal Display Panel (100 units/vial Carton)
A bar graph illustrating the percentage of patients versus change in JRS (Jankovic Rating Scale) scores, comparing treatments with XEOMIN 50 U, XEOMIN 25 U, and placebo. The x-axis shows changes in JRS from -4 to 1, while the y-axis presents patient percentages from 0 to 70%. Different bars represent treatment groups, showing varying patient response distributions across score changes.*
FDA Label Image

Principal Display Panel (100 units/vial Label)

Principal Display Panel (100 units/vial Label)
A bar chart comparing the percentage of patients treated with Xeomin versus placebo across different changes in JRS scores. The x-axis shows change in JRS from -4 to 2, and the y-axis shows the percentage of patients. Black bars represent Xeomin treatment, and gray bars represent placebo.*
FDA Label Image

Principal Display Panel (100 units/vial Carton)

Principal Display Panel (100 units/vial Carton)
A line graph depicting the percentage of subjects with composite treatment success over study days for Xeomin (incobotulinumtoxinA) groups GL-1 and GL-2 compared to placebo. The x-axis represents study days (0 to 120), and the y-axis shows the percentage of subjects, with Xeomin groups peaking around 50-60% success near day 30 and declining thereafter, while placebo remains near zero.*
FDA Label Image

Principal Display Panel (50 units/vial Label)

Principal Display Panel (50 units/vial Label)
Packaging label for Xeomin 50 units/vial injection powder lyophilized for solution, containing incobotulinumtoxinA. The label shows dosage strength of 50 USP units per vial, designated for intramuscular use. It includes manufacturer and distributor details: Merz Pharmaceuticals GmbH, Germany, and Merz North America, Inc., WI. The label features warnings about dosing units and storage instructions, along with barcodes and trademark information.*
FDA Label Image

Principal Display Panel (50 units/vial Carton)

Principal Display Panel (50 units/vial Carton)
Packaging label for Xeomin (incobotulinumtoxinA) injection powder, lyophilized, for solution. The label indicates 100 units per vial strength for intramuscular use. The product is marketed by Merz North America, Inc. and includes warnings about dosing unit interchangeability and instructions for single-dose vial use. The label also provides storage instructions and manufacturer details from Merz Pharmaceuticals GmbH, Germany.*
FDA Label Image

Xeomin 15

Xeomin 15
Packaging label for Xeomin 50 units/vial injection powder, lyophilized, for intramuscular use. The label includes the active ingredient incobotulinumtoxinA with dispensing instructions and warnings. Manufactured by Merz Pharmaceuticals GmbH and distributed by Merz North America, Inc. The bright magenta label features branding and product information including dosage and storage instructions.*

* 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.