Tacrolimus Ointment
Product Images NDC 45802-700

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Tacrolimus (NDC 45802-700). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Padagis Israel Pharmaceuticals Ltd, 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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Structural Formula (7b6280e3 Cbeb 4385 8ab8 263e4405cb6c 01)

Chemical structure of Tacrolimus, the active ingredient in the topical ointment by Padagis Israel Pharmaceuticals Ltd. The diagram depicts the molecular arrangement, including rings and functional groups, characteristic of Tacrolimus.*

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Table 1 (7b6280e3 Cbeb 4385 8ab8 263e4405cb6c 02)

A data table titled 'Global Improvement over Baseline at the End-Of-Treatment in Three Phase 3 Studies' comparing clinical response percentages for Tacrolimus ointment versus vehicle ointment. It covers pediatric patients aged 2-15 years and adult patients, presenting improvement percentages at various thresholds (50%, 75%, 90%, ≥100%) across Tacrolimus 0.03% and 0.1% ointment strengths.*

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Figures 1 And 2 (7b6280e3 Cbeb 4385 8ab8 263e4405cb6c 03)

Two line graphs showing percentage of body surface area affected over a 12-week period. Figure 1 displays data for adult patients with three treatment groups (Vehicle, 0.03%, and 0.1%) while Figure 2 shows pediatric patients with two groups (Vehicle and 0.03%). The y-axis represents the percentage of body surface area affected, and the x-axis represents time in weeks. Error bars indicate mean ± 95% confidence interval.*

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Figures 3 And 4 (7b6280e3 Cbeb 4385 8ab8 263e4405cb6c 04)

Two line graphs titled 'Adult Patients Mean Erythema Over Time' and 'Pediatric Patients Mean Erythema Over Time' showing mean erythema scores over 12 weeks. Data points compare Vehicle, 0.03%, and 0.1% treatments for adults, and Vehicle and 0.03% treatments for pediatric patients, with mean scores and 95% confidence intervals plotted over time in weeks.*

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Table 2 (7b6280e3 Cbeb 4385 8ab8 263e4405cb6c 05)

A data table titled 'Duration of Follow-up in Four Open-label Safety Studies' displaying the number of adult, pediatric, and total participants categorized by time on study intervals: less than 1 year, 1 year or more, 2 years or more, and 3 years or more.*

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Table 3 (7b6280e3 Cbeb 4385 8ab8 263e4405cb6c 06)

A table titled 'Incidence of Treatment Emergent Adverse Events' listing adverse event rates from clinical studies and open-label studies of Tacrolimus Ointment in adults and pediatric patients. The table shows percentages for various adverse events such as skin burning, pruritus, flu-like symptoms, and others across different Tacrolimus concentrations and study types, providing a comprehensive overview of reported side effect incidences.*

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Lion (Lion)

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Carton 30g 03

Packaging label for Tacrolimus Ointment 0.03% in a 30 g tube, distributed by Perrigo. The label shows a rectangular box layout with the product name, strength, and quantity prominently displayed. It includes manufacturer information (LEO Laboratories Ltd., Dublin, Ireland) and usage warnings, specifying that the ointment is for dermatologic use only. The label also states the storage conditions and contains barcodes and product codes.*

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Carton 30g 1

Label for Tacrolimus Ointment 0.1%, topical ointment, 30 g tube, manufactured by LEO Laboratories Ltd and distributed by Perrigo. The label includes drug concentration, NDC 45802-700-00, storage instructions, warnings, and dosage guidance. The packaging emphasizes this is prescription-only medication and for dermatologic use 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.