Intrarosa Insert
Product Images NDC 72495-501

14 FDA label images from Millicent Us, Inc. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 14 technical images submitted to the FDA as part of the official labeling for Intrarosa (NDC 72495-501). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Millicent Us, 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

Small Box (401 28 Image)

Small Box (401 28 Image)
The packaging label for Intrarosa 6.5 mg vaginal inserts includes the proprietary name Intrarosa and the generic name Prasterone. The label states the dosage strength as 6.5 mg per insert and the package contains 28 inserts. The label notes the drug is for vaginal administration and is distributed by Millicent U.S. Inc., manufactured for Endoceutics, Inc. Instructions for use, storage, and handling details are printed on the label along with a barcode and NDC 72495-401-28.*
FDA Label Image

Outer Box (401 28 Outer Box)

Outer Box (401 28 Outer Box)
Box packaging label for Intrarosa Prasterone vaginal inserts, 6.5 mg per insert, containing 28 inserts/applicators. The label includes storage instructions, usage directions, and contact information. The product is manufactured for Endoceutics, Inc. and distributed by Millicent US, Inc.*
FDA Label Image

Small Box (501 14 Image)

Small Box (501 14 Image)
Packaging label for Intrarosa (Prasterone) vaginal inserts, each containing 6.5 mg of prasterone per insert. The label displays the brand name, dosage form, strength, quantity of 14 inserts per package, and manufacturer information including Millicent US, Inc. and Endoceutics, Inc. The label also includes storage instructions and a sample notice stating 'Sample - Not For Sale.'*
FDA Label Image

Outer Box (501 14 Outer Box)

Outer Box (501 14 Outer Box)
The image shows the flat packaging label for Intrarosa Prasterone vaginal inserts, 6.5 mg per insert. The label indicates this is a sample, not for sale, and contains 14 inserts/applicators. The labeler is Millicent US, Inc., with manufacturing by Endoceutics, Inc. It includes storage instructions and contact information for more details.*
FDA Label Image

Prasterone (Intrarosa 01)

Prasterone (Intrarosa 01)
Chemical structure diagram of prasterone, the active ingredient in Intrarosa 6.5 mg vaginal inserts. The diagram shows the steroid backbone with hydroxyl and ketone functional groups characteristic of prasterone.*
FDA Label Image

Figure 1 (Intrarosa 02)

Figure 1 (Intrarosa 02)
A three-panel line graph showing plasma levels over 24 hours post-dosing comparing Intrarosa and placebo. Panel A shows Prasterone (ng/ml) levels elevated after Intrarosa dosing compared to placebo. Panel B depicts Testosterone (ng/ml) levels with slight increases post-Intrarosa dosing versus placebo. Panel C illustrates Estradiol (E2) (pg/ml) levels higher after Intrarosa compared to placebo. Error bars indicate variability at each time point.*
FDA Label Image

Figure 1 (Intrarosa 03)

Figure 1 (Intrarosa 03)
An instructional diagram illustrating the applicator for Intrarosa (prasterone) 6.5 mg vaginal insert. It shows two states of the applicator: non-activated with labeled parts 'Plunger' and 'Open End,' and activated with the plunger extended.*
FDA Label Image

Step 2 (Intrarosa 04)

Step 2 (Intrarosa 04)
An instructional line drawing showing hands holding a small, rounded vaginal insert, demonstrating the proper way to position the insert between the fingers before use.*
FDA Label Image

Step 3 (Intrarosa 05)

Step 3 (Intrarosa 05)
An instructional illustration showing two hands handling a vaginal insert applicator. One hand holds the applicator's barrel while the other hand removes or adjusts the plunger, demonstrating the device's use for inserting the medication.*
FDA Label Image

Step 4 (Intrarosa 06)

Step 4 (Intrarosa 06)
An instructional line drawing showing a right hand holding a vaginal insert applicator by the base, with the other hand pressing the plunger button, demonstrating how to use the applicator device for vaginal insertion of Intrarosa prasterone vaginal insert 6.5 mg.*
FDA Label Image

Step 5 (Intrarosa 07)

Step 5 (Intrarosa 07)
Illustration showing the insertion of an Intrarosa 6.5 mg vaginal insert. The image depicts a hand holding the insert applicator, positioned near the vaginal area, demonstrating proper placement technique for the vaginal route.*
FDA Label Image

Step 6 (Intrarosa 08)

Step 6 (Intrarosa 08)
An instructional diagram depicting the insertion procedure of a vaginal insert, likely representing the use of Intrarosa (prasterone) 6.5 mg. The illustration shows a hand holding the insert, positioned near the vaginal opening with a stylized internal anatomy to demonstrate proper placement.*
FDA Label Image

Step 7 (Intrarosa 09)

Step 7 (Intrarosa 09)
An instructional illustration showing the vaginal insertion of a product, depicting a hand placing an insert into the vaginal canal. The diagram outlines female pelvic anatomy in a simplified style to demonstrate the insertion technique.*
FDA Label Image

Step 8 (Intrarosa 10)

Step 8 (Intrarosa 10)
An instructional diagram shows the insertion of a vaginal insert, illustrating a hand placing the insert into the vaginal canal. The image is likely demonstrating the proper administration technique for the Intrarosa 6.5 mg vaginal insert by Millicent US, Inc.*

* 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.