Estradiol Gel
Product Images NDC 70700-143

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Estradiol (NDC 70700-143). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Xiromed, 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

0.25mg-carton (0.25mg Carton)

The label for Estradiol Gel 0.1% topical gel displays a strength of 0.25 mg per packet, with a quantity of 30 packets per box. The labeler is shown as Xiromed, LLC, and the product is indicated as prescription only (Rx only). The label includes manufacturer information for Laboratorios León Farma in Spain and usage instructions emphasizing topical application and storage conditions.*

FDA Label Image

0.5-mg-carton (0.5 mg Carton)

Packaging label for Estradiol Gel 0.1% 0.5 mg topical gel by Xiromed, LLC. The label indicates the product contains 30 packets, each providing 0.5 mg estradiol in 0.5 g gel. It includes barcodes, the NDC 70700-144-35, and manufacturer information for Laboratorios León Farma, S.A. in León, Spain. The label also notes the product is Rx only and provides storage and usage warnings.*

FDA Label Image

0.75-mg-carton (0.75mg)

Packaging label for Estradiol Gel 0.1% topical gel, strength 0.75 mg per packet, distributed by Xiromed, LLC. The label states 30 packets per package, each containing 0.75 g gel with 0.75 mg estradiol. The label includes usage instructions, warnings, storage conditions, manufacturer information from León Farma, S.A., Spain, and barcodes for scanning.*

FDA Label Image

1.25-mg-carton (1.25mg Carton)

Packaging label for Estradiol Gel 0.1% topical gel, 1.25 mg strength, distributed by Xiromed, LLC. The label indicates a 30-pack size with each 1.25 g gel packet providing 1.25 mg estradiol. The label includes dosage instructions, warnings, storage conditions, and manufacturer information for Laboratorios León Farma, S.A. in Spain. The NDC is 70700-195-35.*

FDA Label Image

1-mg-carton (1mg Carton)

Packaging label for Estradiol Gel 0.1% topical gel by Xiromed, LLC. The label shows the 1 mg strength with 30 packets per package, each packet providing 1 mg estradiol. It includes the NDC 70700-145-35, manufacturer and distributor information, storage instructions, and safety warnings. The product is a prescription drug and the label features a barcode.*

FDA Label Image

Divigel Chemical Structure (Divigel 1)

Chemical structure diagram of estradiol, illustrating the molecular arrangement typical of this hormone. The structure features hydroxyl groups and a fused ring system consistent with estrogen compounds.*

FDA Label Image

Figure 1 (Divigel 2)

A line graph showing mean serum estradiol concentration (pg/mL) over time (hours) for Estradiol Gel in three different doses: 0.25 mg, 0.5 mg, and 1.0 mg. The graph includes error bars indicating variability at each time point up to 24 hours. The 1.0 mg dose shows the highest serum estradiol concentration over time compared to the lower doses.*

FDA Label Image

Figure A (Divigel 6)

An instructional illustration showing a pair of hands tearing open a foil packet, likely demonstrating how to open a single-dose packet for topical Estradiol Gel 0.1%. The image depicts the method of separating the packet at a perforated edge.*

FDA Label Image

Figure B (Divigel 7)

An instructional illustration showing hands applying Estradiol topical gel to the upper thigh area. The image demonstrates the method of topical administration for Estradiol Gel 0.1%, designed for cutaneous application.*

FDA Label Image

Figure C (Divigel 8)

Illustration showing a hand applying topical gel to an upper thigh area, demonstrating the proper site for applying Estradiol Gel 0.1%.*

FDA Label Image

Table-2.jpg (Table 2)

A data table titled 'Mean (%CV) Pharmacokinetic Parameters for Estradiol on Day 14 Following Multiple Daily Doses of Estradiol Gel 0.1%'. It presents pharmacokinetic parameters including AUC, Cmax, Cavg, tmax, and E2:E1 ratio for Estradiol Gel 0.1% at doses of 0.25 g, 0.5 g, and 1.0 g.*

FDA Label Image

Table3-jpg (Table 3)

Data table summarizing changes from baseline in median daily frequency and severity of hot flushes during Estradiol Gel 0.1% treatment compared to placebo, across doses 0.25, 0.5, and 1.0 g/day. The table presents median changes and p-values at weeks 4, 7, and 12 for both frequency and severity of hot flushes.*

* 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.