Estradiol Gel
Product Images NDC 13811-090

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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.

Product Images & Figures Index

FDA Label Image

Table 1 (Estradiol Gel 1)

Table 1 (Estradiol Gel 1)
This is a table displaying the number and percentage of subjects experiencing common adverse reactions during a 12-week study of Estradiol Gel. The table lists the preferred terms for each system organ class, including infections and infestations and reproductive system and breast disorders. The table shows the number of subjects and percentage for each dose category of Estradiol Gel and a placebo group. The adverse reactions reported are those that were experienced by more than 5% of patients in any treatment group.*
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Figure C (Estradiol Gel 10)

Figure C (Estradiol Gel 10)
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Estradiol Gel 0.25 mg Carton (Estradiol Gel 11)

Estradiol Gel 0.25 mg Carton (Estradiol Gel 11)
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Estradiol Gel 0.5 mg Carton (Estradiol Gel 12)

Estradiol Gel 0.5 mg Carton (Estradiol Gel 12)
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Estradiol Gel 0.75 mg Carton (Estradiol Gel 13)

Estradiol Gel 0.75 mg Carton (Estradiol Gel 13)
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Estradiol Gel 1 mg Carton (Estradiol Gel 14)

Estradiol Gel 1 mg Carton (Estradiol Gel 14)
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Estradiol Gel 1.25 mg Carton (Estradiol Gel 15)

Estradiol Gel 1.25 mg Carton (Estradiol Gel 15)
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Estradiol Gel Structural Formula (Estradiol Gel 2)

Estradiol Gel Structural Formula (Estradiol Gel 2)
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Table 2 (Estradiol Gel 3)

Table 2 (Estradiol Gel 3)
The table presents average pharmacokinetic parameters for Estradiol on Day 14 after applying multiple daily doses of Estradiol Gel with different concentrations. The parameters include AUCo24, Crmax, Cavg, tmax, and E2:E1 ratio, and are expressed in different units. The values in parentheses indicate the coefficient of variation (%CV). The results suggest that increasing the concentration of Estradiol Gel leads to higher values for these parameters. The median, minimum, and maximum values are also provided.*
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Figure 1 (Estradiol Gel 4)

Figure 1 (Estradiol Gel 4)
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Table 3 (Estradiol Gel 5)

Table 3 (Estradiol Gel 5)
The table shows the median daily frequency and severity of hot flushes during estradiol gel treatment. The table compares the frequency and severity of hot flushes between different dosages of the gel and placebo over a period of 12 weeks. Median changes are calculated and compared using p-values. Significant differences are shown where p<0.05 based on van Elteren's test stratified by pooled center.*
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Table 4 (Estradiol Gel 6)

Table 4 (Estradiol Gel 6)
This appears to be a table showing relative and absolute risk seen in a study called Esiroger-Alone Substudy of WHI, with various health outcomes such as heart disease, stroke, deep vein thrombosis, pulmonary embolism, breast cancer, and death. The study includes a comparison with a placebo group, and the results appear to be presented as rates per 1000 women-years with confidence intervals. There is no information on the methodology or population used in the study.*
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Table 5 (Estradiol Gel 7)

Table 5 (Estradiol Gel 7)
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Figure A (Estradiol Gel 8)

Figure A (Estradiol Gel 8)
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Figure B (Estradiol Gel 9)

Figure B (Estradiol Gel 9)

* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.