Diazepam Gel
Product Images NDC 68475-803

Product Visual Gallery

This gallery contains 31 technical images submitted to the FDA as part of the official labeling for Diazepam (NDC 68475-803). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Navinta 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

Image (00e3990f 601b 4527 A60a D6cc6be27ee2 01)

Chemical structure of Diazepam, showing its molecular arrangement with characteristic rings and functional groups including a chlorine atom, a nitrogen-containing diazepine ring, and a benzene ring.*

FDA Label Image

Image (00e3990f 601b 4527 A60a D6cc6be27ee2 02)

A line chart depicting mean plasma concentration (ng/mL) of Diazepam over time (hours), comparing 7.5 mg IV Diazepam, 15 mg Diazepam rectal gel, midazolam after 7.5 mg IV, and desmethyldiazepam after 15 mg Diazepam rectal gel. The graph includes data points up to 8 hours, with an inset showing longer-term concentrations up to 240 hours.*

FDA Label Image

Image (00e3990f 601b 4527 A60a D6cc6be27ee2 03)

A horizontal bar chart comparing patients' response to Diazepam Rectal Gel versus placebo by percentage, showing categories of 'Better', 'Same', and 'Worse'. Diazepam Rectal Gel shows 82% better, 13% same, and 4% worse, while placebo shows 33% better, 59% same, and 9% worse.*

FDA Label Image

Image (00e3990f 601b 4527 A60a D6cc6be27ee2 04)

A line graph depicting the probability of no seizure over time (hours) for Diazepam rectal gel compared to placebo. The vertical axis shows the probability of no seizure, ranging from 0 to 1, and the horizontal axis represents time over 24 hours. The graph shows a higher probability of no seizure for Diazepam rectal gel than placebo across the time period.*

FDA Label Image

Image (00e3990f 601b 4527 A60a D6cc6be27ee2 05)

A survival curve chart comparing the probability of no seizure over time (up to 12 hours) between Diazepam Rectal Gel and placebo. The graph shows a higher probability of no seizure for Diazepam Rectal Gel relative to placebo across the time points.*

FDA Label Image

Image (00e3990f 601b 4527 A60a D6cc6be27ee2 06)

Label for Diazepam Rectal Gel 10 mg Delivery System by Navinta LLC featuring a pharmacist warning to dial and lock dose syringes prior to dispensing. The label indicates adjustable dose syringes of 5 mg, 7.5 mg, and 10 mg are available, includes a red stop sign graphic emphasizing dosing instructions, and states the product contains lubricating jelly and instructions.*

FDA Label Image

Image (00e3990f 601b 4527 A60a D6cc6be27ee2 07)

Label for Diazepam Rectal Gel 20 mg Delivery System manufactured by Navinta LLC. The label includes pharmacist dosing instructions, a prominent red stop sign icon, and warnings to lock syringes before dispensing. It notes the product contains two adjustable dose syringes for rectal delivery with lubricating jelly. Available doses displayed include 12.5 mg, 15 mg, 17.5 mg, and 20 mg.*

FDA Label Image

Image (00e3990f 601b 4527 A60a D6cc6be27ee2 08)

Illustration showing pharmacist instructions for Diazepam Rectal Gel Delivery System. It includes four steps: 1) Hold the syringe barrel without removing the cap. 2) Adjust dose by turning the cap to align with the dose window. 3) Lock the dose by pushing the locking ring upward to secure the dose indication. 4) Repeat steps 1-3 for a second syringe if needed, then return both syringes to the case. The diagram emphasizes confirming dose before locking and discarding the instruction card after use.*

FDA Label Image

2.5 mg Container Label (00e3990f 601b 4527 A60a D6cc6be27ee2 09)

Label for Diazepam Rectal Gel 2.5 mg, a rectal gel dosage form indicated for rectal administration only. The label shows the NDC 68475-802-01 and states it is Rx only. It includes storage instructions, the manufacturer Navinta LLC with address in Ewing, NJ, and a barcode. The label is predominantly white with a light blue header and pink accent.*

FDA Label Image

2.5 mg Carton Label (00e3990f 601b 4527 A60a D6cc6be27ee2 10)

The image shows the flattened packaging label for Diazepam Rectal Gel 2.5 mg, a gel dosage form for rectal administration. The label highlights the 2.5 mg strength and mentions a rectal delivery system. The labeler is Navinta LLC. Additional details include a twin pack with two prefilled unit-dose rectal delivery systems and storage instructions at room temperature.*

FDA Label Image

2.5 mg Carton Label-2 (00e3990f 601b 4527 A60a D6cc6be27ee2 11)

Packaging label design for Diazepam rectal gel by Navinta LLC, including line drawings of the rectal gel applicator syringe. The label mentions a Twin Pack containing 2 Quick Delivery Systems, 2 packages of lubricating jelly, and 1 administration instructions sheet. The layout includes dimensions and fold lines for box construction.*

FDA Label Image

Image (00e3990f 601b 4527 A60a D6cc6be27ee2 111 1)

Label image showing the product name Diazepam Rectal Gel. The label features the text prominently with a stylized “Rx” symbol, indicating it is a prescription medication. No dosage strength or manufacturer details are visible in this image.*

FDA Label Image

Image (00e3990f 601b 4527 A60a D6cc6be27ee2 116 1)

The image shows the front label of Diazepam gel for rectal use, manufactured by Navinta LLC. The label displays dosage strengths including 10 mg/2 mL, 2.5 mg/0.5 mL, and 20 mg/4 mL. The packaging is white with clear text indicating the product name and formulations.*

FDA Label Image

Image (00e3990f 601b 4527 A60a D6cc6be27ee2 116 2)

Diazepam 10 mg/2 mL rectal gel in a single-dose syringe with a clear barrel and blue plunger. The syringe displays dosage markings in milliliters. The label includes the Navinta LLC logo and product information printed in blue text on a white background.*

FDA Label Image

Image (00e3990f 601b 4527 A60a D6cc6be27ee2 116 3)

The image shows Diazepam rectal gel packaging with 20 mg/4 mL strength. It is a human prescription drug by Navinta LLC. The pack features branding with the name Diazepam prominently displayed alongside dosage information and volume on a blue and green background.*

FDA Label Image

Image (00e3990f 601b 4527 A60a D6cc6be27ee2 116 4)

Diazepam rectal gel 20 mg per 4 mL carton, labeled by Navinta LLC. The carton includes dosage and volume information. The product is a prescription drug intended for rectal administration.*

FDA Label Image

Image (00e3990f 601b 4527 A60a D6cc6be27ee2 118 1)

Diazepam Rectal Gel 2.5 mg/0.5 mL in a plastic syringe tube with a detachable cap. The syringe barrel has volume markings, and the plunger is visible inside. The labeling includes the product name, strength, and administration route. The product is manufactured by Navinta LLC.*

FDA Label Image

Image (00e3990f 601b 4527 A60a D6cc6be27ee2 118 2)

Diazepam Rectal Gel 10 mg/2 mL in a clear plastic syringe with a white plunger and a blue tip cap. The syringe is marked with measurement graduations and the label displays dosage strength and proprietary name. Labeler is Navinta LLC.*

FDA Label Image

Pdp-10mg (00e3990f 601b 4527 A60a D6cc6be27ee2 12)

Label for Diazepam Rectal Gel 10 mg Delivery System, for rectal administration only. The label includes storage instructions between 20°C to 25°C, a prescription-only note, and a warning to keep the product out of reach of children. It is manufactured by Navinta LLC, Ewing, NJ, with specific instructions not to cover the window with the prescription label.*

FDA Label Image

Image (00e3990f 601b 4527 A60a D6cc6be27ee2 122 1)

An illustration showing two tables intended for recording seizure activity before and after administration of Diazepam Rectal Gel. Each table includes columns for time, seizure type, and number of seizures, designed for tracking patient seizure details.*

FDA Label Image

Image (00e3990f 601b 4527 A60a D6cc6be27ee2 124 1)

FDA Label Image

10 mg Base Paper Tray (00e3990f 601b 4527 A60a D6cc6be27ee2 13)

Packaging label for Diazepam Rectal Gel 10 mg Delivery System by Navinta LLC. The label includes an illustration of the delivery syringe with dose display window and green "READY" band. It lists available doses including 5 mg, 7.5 mg, and 10 mg, and provides storage instructions and caregiver directions. The label also shows the drug is for rectal administration only and is prescription-only.*

FDA Label Image

Image (00e3990f 601b 4527 A60a D6cc6be27ee2 139 1)

A data table for recording seizure activity before and after using Diazepam Rectal Gel. The table includes columns for date, time, seizure type, and number of seizures in two sections labeled 'Seizure Before Diazepam Rectal Gel' and 'Seizure After Diazepam Rectal Gel.' No brand or dosage details are visible in the image.*

FDA Label Image

Pdp-20mg (00e3990f 601b 4527 A60a D6cc6be27ee2 14)

Label for Diazepam Rectal Gel 20 mg Delivery System showing proprietary name, strength, and gel dosage form for rectal administration. The label includes storage instructions, a barcode, manufacturer Navinta LLC details, and a warning to keep out of reach of children. It also notes to avoid covering the window with the prescription label.*

FDA Label Image

20 mg Base Paper Tray (00e3990f 601b 4527 A60a D6cc6be27ee2 15)

Packaging label for Diazepam Rectal Gel 20 mg Delivery System by Navinta LLC. The label displays a syringe with a dose display window and green "READY" band. It lists available doses of 12.5 mg, 15 mg, 17.5 mg, and 20 mg from this delivery system. The label includes storage instructions and directions for caregiver use upon receipt from the pharmacy. RX only, for rectal administration only.*

FDA Label Image

Lubricating Jelly (00e3990f 601b 4527 A60a D6cc6be27ee2 16)

Label for Lubricating Jelly, water soluble, net weight 0.1 OZ (3 g), manufactured by Navinta LLC. The label states it is a lubricant for use with Diazepam rectal gel delivery system and is non-irritating to skin, tissue, and mucous membranes.*

FDA Label Image

Img 4 (00e3990f 601b 4527 A60a D6cc6be27ee2 17)

Illustration of a Diazepam rectal gel applicator showing the dose display window and the green 'READY' band, with instructions to confirm the dose and visibility of the green band before use.*

FDA Label Image

Image (00e3990f 601b 4527 A60a D6cc6be27ee2 18)

Text panel providing contact information for more information and support regarding Diazepam Rectal Gel, including a customer service phone number and an additional resource contact for the Epilepsy Foundation with phone number and website.*

FDA Label Image

Img 1 (00e3990f 601b 4527 A60a D6cc6be27ee2 19)

Step-by-step illustrated instructions for administering Diazepam rectal gel. The images show positioning a person on their side, preparing the medication and syringe, removing the cap with seal pin, lubricating the rectal tip, then positioning the person and exposing the rectum for administration.*

FDA Label Image

Img 2 (00e3990f 601b 4527 A60a D6cc6be27ee2 20)

Instructional illustrations show the administration and disposal steps for Diazepam Rectal Gel. Images depict inserting the syringe tip into the rectum, gently pushing the gel in while counting to three, removing the syringe, holding buttocks to prevent leakage, and keeping the person on their side afterward. Additional disposal steps include pulling and replacing the plunger and discarding used materials safely away from children.*

FDA Label Image

Img 3 (00e3990f 601b 4527 A60a D6cc6be27ee2 21)

A drug facts text panel titled 'Call for Help If Any of the Following Occur' for Diazepam Rectal Gel. It lists conditions for seeking emergency help, including continued seizures 15 minutes after dosing and changes in seizure behavior, severity, or breathing. There are fields to note local emergency number, doctor's number, and emergency squad information including the time the Diazepam Rectal Gel was given and the dose administered.*

* 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.