Estradiol Gel
Product Images NDC 70954-531

Product Visual Gallery

This gallery contains 17 technical images submitted to the FDA as part of the official labeling for Estradiol (NDC 70954-531). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Ani Pharmaceuticals, Inc., 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

Carton-1 (Carton 1)

Box label for Estradiol Gel 0.1% topical gel, with each 0.25 g gel packet providing 0.25 mg estradiol. The package contains 30 packets and is distributed by ANI Pharmaceuticals, Inc. The label includes storage instructions, warnings, and directions for use. NDC 70954-531-20 is visible on the label.*

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Carton-2 (Carton 2)

Packaging label for Estradiol Gel 0.1% topical gel, providing 0.5 mg estradiol per 0.5 g packet. The label indicates a 30-pack size and is distributed by ANI Pharmaceuticals, Inc. The label includes dosage strength, NDC 70954-530-20, storage warnings, and usage instructions.*

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Carton-3 (Carton 3)

Packaging label for Estradiol Gel 0.1% strength topical gel by ANI Pharmaceuticals, Inc. The label states each 0.75 g gel packet provides 0.75 mg estradiol. The carton contains 30 packets and includes the NDC 70954-532-20. The label also features storage and handling instructions, warnings, and distributor information from ANI Pharmaceuticals, Baudette, MN.*

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Carton-4 (Carton 4)

Packaging label for Estradiol Gel 0.1% topical gel, providing 1 mg estradiol per 1 g packet. The box contains 30 packets and is labeled for prescription use only. Distributed by ANI Pharmaceuticals, Inc. The label includes dosing and storage information, warnings, and contact details for reporting side effects.*

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Carton-5 (Carton 5)

Packaging label for Estradiol Gel 0.1% topical gel, containing 1.25 mg estradiol per 1.25 g packet. The label shows the product name, strength, quantity of 30 packets, and indicates it is for prescription use only. Distributed by ANI Pharmaceuticals, Inc., Baudette, MN. The label includes the NDC 70954-534-20 and storage and usage instructions.*

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Pouch-1 (Estradiol 0 25mg)

NDC 70954-531-10 label for Estradiol Gel 0.1%, 0.25 g gel providing 0.25 mg estradiol. Distributed by ANI Pharmaceuticals, Inc., Baudette, MN. Includes lot number, expiration date placeholder, issue date 06/2023, and barcode.*

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Pouch-2 (Estradiol 0 5mg)

Label for Estradiol Gel 0.1%, 0.5 g topical gel tube providing 0.5 mg estradiol, distributed by ANI Pharmaceuticals, Inc. Includes NDC 70954-530-10, lot number X12345X, and issued date 06/2023 with barcode.*

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Pouch-3 (Estradiol 0 75mg)

Label of Estradiol Gel 0.1% topical gel containing 0.75 g of gel providing 0.75 mg of estradiol. Distributed by ANI Pharmaceuticals, Inc., Baudette, MN. Includes NDC 70954-532-10, lot number, expiration placeholder, issue date 06/2023, and a barcode.*

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Pouch-5 (Estradiol 1 25mg)

Label of Estradiol Gel 0.1%, 1.25 g gel providing 1.25 mg of estradiol. Distributed by ANI Pharmaceuticals, Inc., Baudette, MN 56623. Includes lot number X12345X and expiration placeholder. NDC 70954-534-10 barcode is visible.*

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Pouch-4 (Estradiol 1mg)

Label for Estradiol Gel 0.1%, topical gel providing 1 mg of estradiol per 1 g gel. Distributed by ANI Pharmaceuticals, Inc., Baudette, MN. Includes NDC 70954-533-10, lot number X12345X, and issued date 06/2023. Also features a barcode and expiration date placeholder.*

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Figure-a (Figure A)

Illustration showing two hands removing the tip from a tube or small container, likely demonstrating the preparation for use of a topical medication like Estradiol gel.*

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Figure-b (Figure B)

An instructional illustration showing a person in underwear applying a gel to their upper thigh, demonstrating the topical application method commonly used for estradiol gel.*

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Figure-c (Figure C)

An instructional illustration showing a hand applying gel to the inner thigh area of a person's leg, likely demonstrating the topical administration site for Estradiol gel.*

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Figure-one (Figure One)

A line graph showing mean serum estradiol concentration (pg/mL) over 24 hours with three dose groups of Estradiol topical gel: 0.25 mg, 0.5 mg, and 1.0 mg. The x-axis represents time in hours, while the y-axis represents mean serum estradiol concentration. Each dose group shows serum levels fluctuating over time with error bars indicating variability.*

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Estradiol-structure (Structure)

Chemical structure diagram of Estradiol, showing its steroid backbone with hydroxyl groups attached, consistent with the molecular structure of the active ingredient Estradiol in the topical gel form.*

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Table-5 (Table Five)

A data table titled 'Table 5: Relative And Absolute Risk Seen in the Estrogen Plus Progestin Substudy of WHI at an Average of 5.6 Years.' It compares relative risk and absolute risk per 10,000 woman-years for various health events between CE/MPA and placebo groups, including cardiovascular events, strokes, cancers, fractures, mortality, and a global index. Footnotes provide additional clarifications and sources.*

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Table-4 (Table Four)

A data table titled 'Relative And Absolute Risk Seen In The Estrogen-Alone Substudy Of WHI' listing various medical events, their relative risk comparing CE (conjugated estrogens) to placebo with 95% confidence intervals, and absolute risk per 10,000 woman-years for both CE and placebo groups. Events include CHD events, strokes, thromboembolism, cancer types, fractures, mortality, and overall risk indices, with corresponding numerical risk values and notes below the table.*

* 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.