Tacrolimus Ointment
Product Images NDC 0168-0417

Product Visual Gallery

This gallery contains 9 technical images submitted to the FDA as part of the official labeling for Tacrolimus (NDC 0168-0417). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by E. Fougera & Co. A Division Of Fougera Pharmaceuticals, Llc, 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

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Packaging label for Tacrolimus Ointment 0.03% topical ointment by E. Fougera & Co. The label shows the net weight of 60 grams and highlights the strength 0.03% on yellow backgrounds. It includes instructions for dosage to apply twice daily and storage guidelines. The label warns the product is for dermatologic use only and not for ophthalmic use, with additional safety instructions to keep out of reach of children and to dispense with enclosed medication guide.*

FDA Label Image

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Packaging label for Tacrolimus Ointment 0.1% by E. Fougera & Co., a division of Fougera Pharmaceuticals, LLC. The label is for a topical ointment with a net weight of 60 grams. It includes dosage instructions, storage information, and sealing and safety warnings. The label emphasizes that the product is for dermatologic use only and not for ophthalmic use.*

FDA Label Image

Structural Formula (Image 01)

Chemical structure of tacrolimus, the active ingredient in Tacrolimus ointment. The diagram shows the molecular arrangement, including rings, hydroxyl groups, and methyl groups characteristic of tacrolimus.*

FDA Label Image

Figure 1 (Image 02)

A line graph depicting the percentage of body surface area affected (mean ± 95% confidence interval) over 12 weeks. Three data series are shown: Vehicle, 0.03%, and 0.1%, with the x-axis representing time in weeks and the y-axis representing percent body surface area affected. The graph shows a decreasing trend in affected area over time for 0.03% and 0.1%, while the Vehicle remains relatively stable.*

FDA Label Image

Figure 2 (Image 03)

A line graph depicting percent body surface area affected over 12 weeks. The x-axis is labeled 'Time (weeks)' and the y-axis is '% Body Surface Area Affected (mean ± 95% CI)'. Two lines represent treatments labeled 'Vehicle' and '0.03%', showing a decrease over time for the '0.03%' group compared to the 'Vehicle' group.*

FDA Label Image

Figure 3 (Image 04)

A line graph showing mean erythema score over 12 weeks, comparing three groups: vehicle, 0.03%, and 0.1% concentrations. The x-axis represents time in weeks, and the y-axis shows mean erythema score with 95% confidence intervals. The 0.1% group shows the greatest decrease over time, followed by 0.03%, with the vehicle group remaining nearly constant.*

FDA Label Image

Figure 4 (Image 05)

A line graph displaying the mean erythema score with 95% confidence intervals over 12 weeks. Two treatments are compared: Vehicle (black circles) and 0.03% concentration (white circles). The mean erythema score decreases more over time with the 0.03% treatment compared to the Vehicle.*

FDA Label Image

60g Tube 0.03% (Image 06)

Tacrolimus Ointment 0.03% topical ointment label by E. Fougera & Co. The label includes dosage instructions to apply twice daily, storage conditions, and a warning to keep out of reach of children. It weighs 60 grams and states the active ingredient concentration as 0.03%. The label notes the ointment contains 0.03% w/w tacrolimus in a base including white petrolatum, mineral oil, propylene carbonate, white wax, and paraffin.*

FDA Label Image

60g Container 0.1% (Image 08)

Tacrolimus Ointment 0.1% topical ointment in a 60 gram tube by E. Fougera & Co. The label includes dosage instructions to apply twice daily and storage recommendations. It cautions to dispense with medication guide and notes the product is sealed for protection. The ingredients and warnings emphasize dermatologic use only, excluding ophthalmic application, and keeping out of children's reach.*

* 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.