Estradiol Gel
Product Images NDC 13811-090

Product Visual Gallery

This gallery contains 15 technical images submitted to the FDA as part of the official labeling for Estradiol (NDC 13811-090). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Trigen Laboratories, 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.

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Table 1 (Estradiol Gel 1)

Data table showing the number and percentage of subjects experiencing common adverse reactions in a 12-week placebo-controlled study of Estradiol Gel at doses of 0.25, 0.5, and 1.0 grams per day compared to placebo. The table categorizes adverse reactions by system organ class, including infections and infestations such as nasopharyngitis and vaginal mycosis, as well as reproductive system and breast disorders like breast tenderness and metrorrhagia.*

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Figure C (Estradiol Gel 10)

An instructional line drawing showing a person applying topical gel to the upper thigh area. The image depicts the use of Estradiol topical gel by hand application to skin, focusing on the thigh region as the site of administration.*

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Estradiol Gel 0.25 mg Carton (Estradiol Gel 11)

Packaging label for Estradiol Gel 0.1% strength providing 0.25 mg estradiol per 0.25 g gel packet. The label shows it is a topical gel formulation in 30 packets per package. Manufactured by Orion Corporation Orion Pharma in Finland and labeled by Trigen Laboratories, LLC. The label includes the NDC code 13811-090-32 and marks the product as Rx only.*

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Estradiol Gel 0.5 mg Carton (Estradiol Gel 12)

Packaging label for Estradiol Gel 0.1%, 0.5 mg strength, topical gel in 30 packets. The label shows that each 0.5 g gel packet provides 0.5 mg estradiol. It is labeled Rx only and manufactured for Trigen Laboratories, LLC, Alpharetta, GA. The label also includes NDC 13811-091-32 and product information indicating it is made in Finland by Orion Pharma.*

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Estradiol Gel 0.75 mg Carton (Estradiol Gel 13)

Carton packaging for Estradiol Gel 0.1%, 0.75 mg topical gel by Trigen Laboratories. The label notes a quantity of 30 packets, each providing 0.75 mg estradiol per 0.75 g gel. Manufactured by Orion Pharma in Finland and labeled for prescription use only. The prominent text includes the strength 0.75 mg and product name Estradiol Gel 0.1%.*

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Estradiol Gel 1 mg Carton (Estradiol Gel 14)

Packaging label for Estradiol Gel 0.1% (1 mg/g) topical gel by Trigen Laboratories LLC. The label states 30 packets per container, each packet providing 1 mg estradiol. Manufacturer information for Orion Corporation Orion Pharma, Finland, is also visible. The label includes NDC 13811-093-32 and Rx only designation.*

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Estradiol Gel 1.25 mg Carton (Estradiol Gel 15)

Estradiol Gel 1.25 mg (0.1%) topical gel packaging label for 30 packets, with each packet providing 1.25 mg estradiol. The label shows the Trigen Laboratories logo and indicates the product is Rx only. Manufactured by Orion Corporation Orion Pharma, Finland, and labeled for Trigen Laboratories, Alpharetta, GA. The label includes a barcode, NDC 13811-094-32, and space for expiration date and lot number.*

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Estradiol Gel Structural Formula (Estradiol Gel 2)

Chemical structure of estradiol showing its steroidal framework with hydroxyl groups attached, consistent with the active ingredient in Estradiol topical gel products by Trigen Laboratories.*

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Table 2 (Estradiol Gel 3)

Data table showing mean pharmacokinetic parameters for Estradiol Gel at doses of 0.25 grams, 0.5 grams, and 1.0 gram on day 14 following multiple daily doses. Parameters include AUC, Cmax, Cavg, tmax (median and range), and E2:E1 ratio with respective values for each dose.*

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Figure 1 (Estradiol Gel 4)

A line graph showing mean serum estradiol concentration (pg/mL) over time (hours) following administration of Estradiol gel at doses of 0.25 mg, 0.5 mg, and 1.0 mg. The graph depicts concentration levels rising and then gradually declining over a 24-hour period, with error bars indicating variability at each time point.*

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Table 3 (Estradiol Gel 5)

A data table summarizing changes from baseline in the median daily frequency and severity of hot flushes during Estradiol Gel treatment compared to placebo. The table shows evaluations at different doses of Estradiol Gel (0.25, 0.5, and 1.0 grams per day) across several weeks, with baseline medians and median changes including associated p-values indicating statistical significance.*

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Table 4 (Estradiol Gel 6)

A data table titled 'Relative And Absolute Risk Seen In The Estrogen-Alone Study Of WHI' displaying relative risk and absolute risk per 10,000 woman-years for various medical events comparing CE (conjugated estrogens) and placebo groups. The table includes event types such as CHD events, strokes, thrombosis, cancers, fractures, death causes, and overall mortality, with sample sizes of 5,310 for CE and 5,429 for placebo. Footnotes provide context for data sources and definitions.*

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Table 5 (Estradiol Gel 7)

Table presenting relative and absolute risk seen in the Estrogen Plus Progestin substudy of the WHI over an average of 5.6 years. It includes event types such as CHD events, strokes, cancers, fractures, and mortality, comparing CE/MPA versus placebo groups with relative risk values and absolute risk per 10,000 woman-years.*

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Figure A (Estradiol Gel 8)

An instructional illustration showing a person's hands peeling apart a protective wrap or seal. This image likely demonstrates how to open a package or applicator related to the Estradiol topical gel product.*

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Figure B (Estradiol Gel 9)

An instructional illustration depicts a person applying topical gel to the inner thigh area, demonstrating the site for administration of a product like Estradiol topical gel.*

* 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.