Vivelle Dot
Product Images NDC 54868-4242

Product Visual Gallery

This gallery contains 19 technical images submitted to the FDA as part of the official labeling for Vivelle Dot (NDC 54868-4242). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Physicians Total Care, 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

Image Of 0.05 mg Package Label (4242)

Packaging label for Vivelle Dot transdermal system containing 0.05 mg active ingredient, distributed by Physicians Total Care, Inc. The label includes the NDC number 54868-4242-0, a lot number, expiration date of 01/60, and manufacturer information for Noven Pharm., Inc., Miami FL 33186. The pack contains 8 patches.*

FDA Label Image

Image Of 0.75 mg Package Label (4243)

Packaging label for Vivelle Dot transdermal system showing the active ingredient strength as 0.075 mg. The label indicates a quantity of 8 units and includes an expiration date of 01/60. Distributed by Physicians Total Care, Inc., Tulsa, OK, with manufacturing by Modern Pharm., Inc., Miami, FL. A barcode is also visible on the label.*

FDA Label Image

Image Of 0.1 mg Package Label (4244)

Vivelle Dot transdermal patch 0.1 mg packaging label distributed by Physicians Total Care, Inc. The label includes the National Drug Code (NDC) 54868-4244-0 and indicates an 8-count package. It also shows the lot number and expiration date information, as well as a barcode.*

FDA Label Image

Image Of 0.0375 mg Package Label (4920)

A white distribution label showing product name Vivelle Dot transdermal system 0.0375 patch, with lot number and expiration date 01/60. It is distributed by Physicians Total Care, Inc., Tulsa, OK. The label includes an NDC number 54868-4920-0 and a barcode.*

FDA Label Image

Estradiol Structural Formula (Vivelle Dot 02)

Chemical structure diagram of the active ingredient in Vivelle Dot, showing a multi-ring steroid framework with hydroxyl (OH) and methyl (CH3) substituents, representing an estrogen molecule characteristic of the product's hormone composition.*

FDA Label Image

Vivelle-dot Layer Image (Vivelle Dot 03)

FDA Label Image

Figure 1steady State Estradiol Plasma Concentrations For Systems Applied To The Abdomennonbaseline Corrected Levels (Vivelle Dot 04)

A line graph depicting the concentration (pg/mL) of Vivelle Dot over time (days) for four dosage levels: 0.1 mg/day, 0.075 mg/day, 0.05 mg/day, and 0.0375 mg/day. The graph shows concentration trends for each dosage from day 0 to day 4.*

FDA Label Image

Figure 2 Mean (sd) Change From Baseline In Mean Daily Number Of Flushes For Vivelle® 0.0375 mg Versus Placebo In A 12 Week Trial. (Vivelle Dot 05)

A bar chart showing mean (SD) reduction from baseline over weeks 4, 8, and 12 comparing Vivelle 0.0375 mg/day and placebo. Bars indicate greater reductions for Vivelle at each time point, with sample sizes listed below each bar. The graph notes statistically significant differences (p<0.05) between Vivelle and placebo at all time points.*

FDA Label Image

Figure 3 Bone Mineral Density Ap Lumbar Spine Least Squares Means Of Percentage Change From Baseline All Randomized Patients With At Least One Post Baseline Assessment Available With Last Post Baseline Observation Carried Forward (Vivelle Dot 06)

A line graph showing percent change from baseline over treatment duration in weeks (26, 52, 78, 104) for Vivelle Dot at dosages of 0.1 mg/day, 0.05 mg/day, 0.0375 mg/day, 0.025 mg/day, and placebo. The graph plots five different lines, each representing a different dosage or placebo, illustrating their effect over time.*

FDA Label Image

Figure 4 Bone Mineral Density Femoral Neck Least Squares Means Of Percentage Change From Baseline All Randomized Patients With At Least One Post Baseline Assessment Available With Last Post Baseline Observation Carried Forward (Vivelle Dot 07)

A line graph showing percentage change from baseline over treatment duration in weeks (26, 52, 78, 104). The graph compares Vivelle Dot transdermal estradiol at doses 0.1 mg/day, 0.05 mg/day, 0.0375 mg/day, 0.025 mg/day, and placebo. The vertical axis ranges from -4 to 7 percent change, and statistical significance markers (p<0.05) are indicated for comparisons between Vivelle Dot doses and placebo at several time points.*

FDA Label Image

Determine Your Schedule For Your Twice-a-week Application (Vivelle Dot 08)

Vivelle Dot label panel showing dosage scheduling options for the estradiol transdermal system. The panel includes checkboxes for various two-day patch change schedules such as Sun/Wed, Mon/Thu, Tue/Fri, Wed/Sat, Thu/Sun, Fri/Mon, and Sat/Tue, to guide patients in changing the patch on the correct days.*

FDA Label Image

Where To Apply Vivelle-dot® (Vivelle Dot 09)

An instructional illustration showing a hand applying a Vivelle Dot transdermal patch to the skin of the lower abdomen area. The image focuses on the placement process of the patch on the body.*

FDA Label Image

Before You Apply Vivelle-dot® (Vivelle Dot 0a)

FDA Label Image

How To Apply Vivelle-dot® 1 (Vivelle Dot 0b)

Illustration showing hands peeling a backing off a square adhesive, likely depicting how to open or handle a transdermal patch such as Vivelle Dot.*

FDA Label Image

How To Apply Vivelle-dot® 2 (Vivelle Dot 0c)

An instructional illustration depicting a pair of hands peeling apart a thin adhesive patch, demonstrating how to open or prepare the patch for application.*

FDA Label Image

How To Apply Vivelle-dot® 3 (Vivelle Dot 0d)

An instructional diagram showing a hand applying a small, round patch to the lower abdomen. The illustration indicates the proper placement of the patch on the skin, likely demonstrating use instructions for a transdermal product, Vivelle Dot.*

FDA Label Image

How To Apply Vivelle-dot® 4 (Vivelle Dot 0e)

An instructional illustration showing two hands applying or handling a small adhesive patch, likely representing the use or application method for Vivelle Dot transdermal patches.*

FDA Label Image

How To Apply Vivelle-dot® 5 (Vivelle Dot 0f)

An instructional illustration showing hands applying a Vivelle Dot transdermal patch to the skin. The image demonstrates the proper placement and adhesion method for the patch, emphasizing clean and careful application.*

FDA Label Image

How To Apply Vivelle-dot® 6 (Vivelle Dot 10)

An anatomical line drawing illustrating the application site on the skin for a transdermal product, shown on the inner forearm near the wrist. The hand and lower arm are shown palm-side up.*

* 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.