Ameluz Gel
Product Images NDC 70621-101

Product Visual Gallery

This gallery contains 139 technical images submitted to the FDA as part of the official labeling for Ameluz (NDC 70621-101). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Biofrontera 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.

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Figure 1a: Degreasing Of The Skin (Figure1a)

A close-up photographic illustration showing a gloved hand applying a white gauze pad to a person's forehead. The image suggests topical application consistent with the use of a gel product applied to the skin.*

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Figure 1b: Figure 1b: Removal Of Scales And Crusts (Figure1b)

A clinical illustration showing a healthcare professional applying topical gel onto the skin of a patient's scalp area using a gloved hand. The image likely depicts the application of AMELUZ gel containing aminolevulinic acid hydrochloride, used topically.*

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Figure 2: Drug Application (Figure2)

Photograph showing a close-up of a person’s forehead with a hand wearing a blue glove applying a topical gel using a wooden applicator stick. This image suggests the application method of a topical gel product like AMELUZ (aminolevulinic acid hydrochloride) gel 100 mg/g.*

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Figure 3: Occlusion (Figure3)

An instructional or procedural image showing a person's forehead covered with protective gauze and partially with a reflective foil or metallic protective covering, likely related to a topical treatment application process.*

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Figure 4a: Illumination With Bf-rhodoled (Figure4a)

Illustration showing a bald patient undergoing topical treatment to the scalp using a photodynamic device emitting red light, associated with AMELUZ (aminolevulinic acid hydrochloride) gel for prescription use. The image focuses on the application process involving light activation.*

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Figure 4b: Illumination (3 Panels) (Figure4b 3panel)

Illustration showing a person receiving light therapy from a three-panel device emitting red light. The device is positioned around the person's head, suggesting use in conjunction with topical treatment application, such as AMELUZ gel for skin conditions.*

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Figure 4b: Illumination With Rhodoled Xl (examples With 3 And 5 Panels) (Figure4b)

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Ala.hcl (Structural Formula)

Chemical structure diagram of aminolevulinic acid hydrochloride, the active ingredient in AMELUZ topical gel 100 mg/g. The structure shows the molecular arrangement including amino, carboxyl, and hydrochloride groups.*

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An instructional illustration depicting a person reading written information. The image shows a simplified icon-style figure holding and looking at a document or booklet.*

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Illustrations showing storage and handling instructions for a pharmaceutical product: an umbrella icon with 'Keep dry' text in German and English, a wine glass indicating fragility, a thermometer showing storage temperature from -30°C to +60°C (-22°F to +140°F), a humidity symbol indicating a range from 10% to 90%, and a pressure symbol with values 5 kPa to 10.6 kPa.*

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Figure 01 (Um Figure 01)

An instructional or warning diagram showing an articulated arm extending between two devices with warning arrows pointing downward to a caution symbol depicting a hand receiving an electric shock. It likely illustrates an electrical hazard risk associated with the equipment's articulated arm.*

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Figure 02 (Um Figure 02)

A line graph labeled BF-RhodoLED® showing spectral irradiance (W/m²/nm) on the vertical axis versus wavelength (nm) on the horizontal axis, with a peak near 630 nm. An inset graph displays fluorescence intensity (arbitrary unit) versus wavelength (nm) with multiple curves at different conditions.*

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Figure 03 (Um Figure 03)

An instructional diagram of a medical device with labeled components including a storage shelf with control unit, an adjustable distance indicator on an articulated arm, a lamp head with holding bracket, a mobile frame on a four-caster base, and the lamp base with power and accessory supply. The device appears designed for clinical or therapeutic use.*

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Figure 04 (Um Figure 04)

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Figure 05 (Um Figure 05)

An illustration showing two close-up views of a medical device component, each highlighted with a red circle. The images focus on specific parts of the equipment, likely related to application or measurement functions. No product labeling or text is visible in the image.*

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Figure 06 (Um Figure 06)

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Figure 08 (Um Figure 08)

An interface screen showing three rectangular buttons labeled Treatment, Settings, and Service. The screen includes the Biofrontera logo with the tagline 'care together more than' in the top right corner and a power button icon in the top left corner.*

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Figure 09a (Um Figure 09a)

An image showing a healthcare professional wearing protective glasses and a white coat using a specialized blue and white device emitting red light on a patient's face, who is lying down and also wearing protective glasses. The scene represents a clinical or therapeutic procedure involving topical treatment, possibly photodynamic therapy.*

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Figure 09b (Um Figure 09b)

An image of a medical device labeled 'dr.RhodoLED,' featuring a rectangular panel with multiple small LED lights arranged in rows, designed for topical photodynamic therapy in conjunction with gel medications like AMELUZ aminolevulinic acid hydrochloride.*

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Figure 10 (Um Figure 10)

An instructional diagram showing a software interface screen from Biofrontera for AMELUZ topical gel treatment. The screen displays a graph labeled 'Active profile: Profile standard' with efficacy percentage on the Y-axis and time in minutes on the X-axis, plus buttons labeled 'Adjust,' 'Start,' and 'Back.' An annotation explains that the 'Adjust' button takes the user to a lamp head positioning adjustment screen used before treatment.*

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Figure 11 (Um Figure 11)

Two screen interface images displaying options related to adjustments. The left screen shows buttons labeled 'Start adjustment' and 'Back,' while the right screen shows buttons labeled 'Stop adjustment' and 'Back.' Both screens include the Biofrontera logo and tagline in the top right corner.*

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Figure 12 (Um Figure 12)

Instructional diagram showing a device screen interface used in a treatment process. The screen displays a graph labeled 'Active profile: Profile standard' with treatment time of 10 minutes. Three buttons labeled 'Adjust,' 'Start,' and 'Back' correspond to navigation functions for light adjustment, starting treatment, and returning to the home screen, respectively. The diagram includes arrows explaining the purpose of each button.*

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Figure 13 (Um Figure 13)

An instructional diagram showing a user interface for a treatment device by Biofrontera. It displays a graph, fan power controls with buttons (-10, -1, +1, +10) at 20%, and a timer with remaining time 00:10:00. Buttons labeled Start, Break, and Stop have corresponding instructions: Start to begin or resume treatment, Break to pause, and Stop to abort treatment.*

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Figure 14 (Um Figure 14)

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Figure 15 (Um Figure 15)

A user interface screen showing language selection options including English, Español, Française, and Deutsch, with navigation buttons labeled Back and OK at the bottom.*

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Figure 18 (Um Figure 18)

A user interface screen showing sound settings with options for 'Sound on typing,' 'Warning sound,' and 'Sounds during treatment,' each with checkboxes to enable or disable. Buttons labeled 'Back' and 'OK' are at the bottom for navigation.*

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Figure 19 (Um Figure 19)

A user interface screen displaying lamp auto-off settings with options to adjust time by increments of -10, -1, +1, and +10 minutes. It shows a checkbox labeled 'Never turn off lamp automatically' that is checked, and buttons labeled 'Back' and 'OK' at the bottom. The screen appears to be part of a device control panel, unrelated to drug packaging or labeling.*

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Figure 20 (Um Figure 20)

Label from a medical device manufactured by Biofrontera Pharma GmbH, Germany. The label provides manufacturer contact details, order number, serial number, electrical specifications including power supply and input, device weight, and certification marks. A barcode and device image are also visible. The label is related to Biofrontera's product line but does not show AMELUZ gel packaging or drug information.*

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Figure 21 (Um Figure 21)

Label panel from a light source device used in conjunction with AMELUZ gel 100 mg/g (aminolevulinic acid hydrochloride) topical product by Biofrontera Inc. The panel includes safety and usage warnings, specifying the device emits bright red light at 635 nm wavelength and eye protection is required during use to prevent irritation or injury.*

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Figure 22 (Um Figure 22)

An instructional illustration showing a laboratory or medical device with attached safety warnings. The diagram includes caution icons and text advising against placing the unit on unstable surfaces, warning about potential obstruction of extension and scissors arms, instructing to transport the lamp securely on even surfaces, and specifying that assembly and servicing must be done only by Biofrontera personnel.*

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Figure 23 (Um Figure 23)

An illustration showing a reflective light path between two articulated arm devices with a safety warning symbol indicating caution for laser or concentrated light exposure. The image demonstrates the reflection angles between the devices.*

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Figure 24 (Um Figure 24)

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Figure 25 (Um Figure 25)

An illustration showing a medical device on wheels with a mechanical arm and a mounted apparatus, labeled with a note indicating the location of a cover box on the base of the device. A close-up photograph focuses on the cover box area, showing a grey panel with a circular white symbol.*

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Figure 26 (Um Figure 26)

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AMELUZ 100 mg/g gel in a white and blue tube with a barcode and text label, by Biofrontera Inc. The label displays the proprietary name AMELUZ, the active ingredient aminolevulinic acid hydrochloride, and the concentration 100 mg/g. This topical gel packaging is primarily white with blue accents and detailed product information visible on the tube.*

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Figure 01 (Um Xl Figure 01)

An illustration showing a device with panels emitting red light dots focused on a target area, accompanied by a graph plotting light intensity versus wavelength. The graph demonstrates a light emission spectrum peaking around 635 nm wavelength.*

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Figure 02 (Um Xl Figure 02)

Illustrated diagram of a medical device featuring a lamp head composed of 5 LED panels with a distance sensor, attached to a spring arm and telescope suspension. The device includes a control unit mounted on a mobile base and support rail, with a lamp base that has 4 castors and a power supply. Components are labeled to show device structure and functionality.*

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Figure 03 (Um Xl Figure 03)

An instructional illustration showing a clinical device with a vertical arm and attached components, along with close-up views of a control knob or attachment mechanism on the device.*

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Figure 04 (Um Xl Figure 04)

An instructional diagram showing a device with hinged arms being rotated from an open, outward position to a closed, inward position. The illustration uses arrows to indicate the rotational movement of the device's parts.*

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Figure 05 (Um Xl Figure 05)

An instructional diagram showing the adjustable positioning of a headband device. The illustration includes arrows indicating horizontal sliding movement on the top strap and rotational movement around the head, demonstrating how to fit the device securely.*

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Figure 06 (Um Xl Figure 06)

An instructional diagram showing a device with a rectangular screen that can be swiveled from a flat to a rotated position, demonstrated in three stages with arrows indicating the direction of rotation.*

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Figure 07 (Um Xl Figure 07)

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Figure 09 (Um Xl Figure 09)

An instructional display panel showing a 10-minute treatment timer with percentage progress on a graph. It includes settings icons, a power-off button, and a representation of five active LED panels each spaced 4.9 inches apart. The interface also features a Start button to control the treatment process.*

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Figure 10 (Um Xl Figure 10)

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Figure 13 (Um Xl Figure 13)

An instructional illustration showing a human head positioned inside a device with four panels surrounding it. The diagrams depict the head from two angles—one from the side and one from above—highlighting the setup likely used in a medical or dermatological treatment procedure involving the head.*

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Figure 14 (Um Xl Figure 14)

AMELUZ 100 mg/g topical gel by Biofrontera Inc. The image shows a device with multiple panels emitting red light, which appears related to the AMELUZ treatment system for topical application but does not show the gel's packaging itself.*

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Figure 15 (Um Xl Figure 15)

An instructional screen for AMELUZ (aminolevulinic acid hydrochloride) topical gel, 100 mg/g, reminding users that everyone present should wear appropriate eye protection. The screen instructs to press OK to start treatment or Cancel to return to the menu.*

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Figure 16 (Um Xl Figure 16)

User interface illustration showing a digital timer counting down from 09:54 minutes with a graphical bar representing treatment progress. Below are five active LED panel indicators each marked with 4.9 inch distance, and control buttons labeled Pause and Cancel. Annotations describe a top settings menu, power off button, and treatment control options including start, pause, resume, or abort.*

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Figure 17 (Um Xl Figure 17)

An instructional diagram displaying user interface buttons for treatment control. The top row shows 'Pause' and 'Cancel' buttons with instructions to press 'Pause' to pause active treatment or 'Cancel' to cancel treatment. The bottom row shows 'Continue' and 'Cancel' buttons with instructions to press 'Continue' to resume treatment or 'Cancel' to cancel treatment.*

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Figure 18 (Um Xl Figure 18)

An instructional screen display showing a prompt to abort or continue treatment with two selectable buttons labeled Yes and No. The prompt indicates the amount of treatment achieved and the remaining treatment time. Text instructions explain pressing Yes cancels treatment and pressing No continues it.*

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Figure 19 (Um Xl Figure 19)

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Figure 20 (Um Xl Figure 20)

A warning panel titled 'Attention' stating that setup, service, and maintenance may only be performed by Biofrontera, the labeler of the product AMELUZ aminolevulinic acid hydrochloride topical gel.*

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Figure 21 (Um Xl Figure 21)

A data table listing technical specifications and regulatory information for the RhodoLED XL medical device by Biofrontera Pharma GmbH. It includes manufacturer details, protection class (IP20), power supply specifications, device weight, order numbers, and compliance certifications. The table also features a UL certification mark and QR code.*

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Figure 22 (Um Xl Figure 22)

An instructional label showing a warning that setup, service, and maintenance must only be performed by Biofrontera. The label includes symbols prohibiting walking in an area and disposal of an item in trash, alongside a base with wheels, likely part of medical equipment.*

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Figure 23 (Um Xl Figure 23)

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Figure 24 (Um Xl Figure 24)

A warning and safety instruction panel titled "Attention:" related to a light source emitting bright red light at approximately 635 nm. It includes safety precautions such as not staring into the light source and the necessity for protective eye equipment. The panel also mentions LED and laser classifications, treatment time of 10 minutes, and maximum LED output power of 73.2 mW/cm². The bottom of the panel is labeled "Panel 3."*

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Figure 25 (Um Xl Figure 25)

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AMELUZ 100 mg/g gel topical prescription drug packaging shows the product name prominently along with the active ingredient aminolevulinic acid hydrochloride. The label includes the formulation as a gel and displays the manufacturer Biofrontera Inc. The package also indicates the NDC 70621-101.*

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AMELUZ 100 mg/g topical gel packaging label displays the product name prominently with active ingredient aminolevulinic acid hydrochloride indicated. The label includes a clear view of the dosage form as a gel and the labeler Biofrontera Inc. The design features orange and white color blocks with the NDC 70621-101 visible.*

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An instructional icon showing a person reading a booklet or pamphlet, commonly used to indicate that the patient should read the accompanying medication guide or instructions before use.*

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AMELUZ 100 mg/g topical gel pharmaceutical bottle with a white cap and a warning triangle symbol on the label, indicating caution. The label is primarily white with some red and gray areas. The product is labeled for topical use and manufactured by Biofrontera Inc.*

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Packaging label for AMELUZ 100 mg/g topical gel. The product contains aminolevulinic acid hydrochloride as the active ingredient, indicated for human prescription use. The label includes the product name, strength, dosage form, and the labeler Biofrontera Inc. The NDC 70621-101 is also visible.*

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Figure 00 (Um Xl C Cover)

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Figure 01 (Um Xl C Figure 01)

A scientific graph showing a wavelength spectrum with light intensity (μW/cm²/nm) plotted on the vertical axis and wavelength (nm) on the horizontal axis. A peak is visible around 635 nm, indicating the emission characteristics of the light source shown in the adjacent device image, likely related to AMELUZ photodynamic therapy equipment.*

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Figure 02 (Um Xl C Figure 02)

An annotated illustration of a medical device stand with a lamp head consisting of 5 LED panels with distance sensor, mounted on a spring arm and telescope suspension. It features a control unit attached to the main mobile base and support rail, which rests on a lamp base with 4 castors and power supply, designed for flexible positioning and mobility.*

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Figure 03 (Um Xl C Figure 03)

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Figure 04 (Um Xl C Figure 04)

An instructional illustration showing how to rotate a device or component by turning it clockwise. The image depicts two views of the device before and after rotation, with arrows indicating the turning direction.*

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Figure 05 (Um Xl C Figure 05)

An instructional illustration showing a device or screen mounted on a vertical pole or stand. It depicts three stages of rotating the screen holder: the screen is shown first facing sideways, then angled forward, and finally rotated to a forward-facing position, with arrows indicating the direction of rotation.*

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Figure 06 (Um Xl C Figure 06)

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Figure 08 (Um Xl C Figure 08)

Illustration of a device interface showing treatment progress with a 10-minute timer, LED panel activation indicators, treatment distances in inches, and control buttons for starting, pausing, resuming, or aborting the treatment. The top bar includes settings and power-off icons.*

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Figure 09 (Um Xl C Figure 09)

The image shows a carton of AMELUZ 100 mg/g topical gel by Biofrontera Inc. The packaging highlights AMELUZ as a gel containing aminolevulinic acid hydrochloride, intended for topical use. The box design includes a checkmark graphic pattern and a blue color accent on the side.*

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Figure 12 (Um Xl C Figure 12)

An illustration showing a human head inside an open device or compartment with a red interior and white exterior panels, viewed from a side angle and from above. The image appears to depict positioning or placement instructions for the head relative to the device.*

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Figure 13 (Um Xl C Figure 13)

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Figure 14 (Um Xl C Figure 14)

An instructional screen for AMELUZ gel treatment displaying a safety reminder to ensure everyone present wears adequate eye protection. It includes options to press OK to start the treatment or Cancel to return to the menu, highlighting safe usage procedures.*

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Figure 15 (Um Xl C Figure 15)

An interface diagram showing a digital treatment progress display with a timer reading 06:38, a graphical progress bar, and indicators of treatment distance set at 4.7 inches for five active LED panels. The screen includes options to pause or cancel the treatment and icons for settings and power off functions. This likely relates to a device or application used in conjunction with AMELUZ gel treatment.*

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Figure 16 (Um Xl C Figure 16)

Two screenshots show user interface buttons and instructions related to treatment control. The first image shows 'Pause' and 'Cancel' buttons with instructions to press Pause to pause active treatment and Cancel to cancel treatment. The second image shows 'Continue' and 'Cancel' buttons with instructions to press Continue to resume paused treatment and Cancel to cancel treatment.*

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Figure 17 (Um Xl C Figure 17)

An instructional user interface screen showing an option to cancel or continue treatment. It displays the current and total treatment dose in J/cm², remaining treatment time, and two buttons: 'Yes' to cancel the treatment and 'No' to continue.*

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Figure 18 (Um Xl C Figure 18)

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Figure 19 (Um Xl C Figure 19)

A cautionary notice stating that setup, service, and maintenance may only be performed by Biofrontera, the labeler of AMELUZ (aminolevulinic acid hydrochloride) topical gel 100 mg/g.*

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Figure 20 (Um Xl C Figure 20)

A product data label for RhodoLED XL-C medical device by Biofrontera Discovery GmbH in Germany. It details classification as a class III medical device and class I medical equipment, power requirements (100-120 VAC, 60 Hz, 750 VA), weight (approx. 75 kg), and compliance certifications including UL certification and relevant IEC standards, along with manufacturing and order identification numbers and UDI QR codes.*

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Figure 21 (Um Xl C Figure 21)

A warning panel titled 'Attention' stating that setup, service, and maintenance may only be performed by Biofrontera, featuring a no entry symbol over a human figure and a crossed-out trash bin icon.*

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Figure 22 (Um Xl C Figure 22)

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Figure 23 (Um Xl C Figure 23)

A caution and safety instructions panel for light source use, indicating it emits bright red light at approximately 635 nm wavelength. It warns against staring into the light, mandates use of protective eye equipment by patients and operators during a 10-minute treatment, and provides LED and laser classification information. The panel is labeled 'Panel 3'.*

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An instructional diagram illustrating a person holding and reading a medication guide or drug information leaflet. The icon suggests guidance on proper use or safety information related to a pharmaceutical product.*

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AMELUZ gel, 100 mg/g aminolevulinic acid hydrochloride, topical human prescription drug by Biofrontera Inc. The image shows a white squeeze tube with a matching white and red cardboard carton. Both display the product name AMELUZ prominently in red, with active ingredient and strength below. The carton includes the labeler name and product NDC 70621-101, along with usage instructions and warnings in smaller text.*

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Figure6 (Figure6)

Packaging labels for AMELUZ (aminolevulinic acid HCl) topical gel, 10%, 100 mg/g strength, from Biofrontera Inc. The image shows three packaging types: a single carton and a physician's sample carton each containing 2 g net weight, marked Rx Only with storage instructions; and a multipack carton holding ten 2 g tubes. All labels note use with BF-RhodoLED or RhodoLED XL lamp for healthcare professionals only.*

* 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.