Diazepam Gel
Product Images NDC 70710-2078

Product Visual Gallery

This gallery contains 31 technical images submitted to the FDA as part of the official labeling for Diazepam (NDC 70710-2078). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Zydus Pharmaceuticals Usa 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.

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Chemical structure of Diazepam, showing a benzodiazepine core with chlorine, nitrogen, and ketone functional groups.*

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A pharmacokinetic graph showing mean plasma concentration (ng/mL) over time (hours) for diazepam after various administration routes and dosages, including 7.5 mg intravenous (IV), 15 mg diazepam rectal gel, and their metabolite desmethyldiazepam levels after the same treatments. The graph compares plasma concentrations from IV and rectal gel administration of diazepam and desmethyldiazepam over an 8-hour period.*

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A horizontal bar chart comparing patient responses to Diazepam Rectal Gel versus placebo. It shows percentages of patients reporting outcomes as better, same, or worse. Diazepam Rectal Gel has 82% reporting better, 13% same, and 4% worse. Placebo shows 33% better, 59% same, and 9% worse outcomes.*

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A line graph comparing the probability of no seizure over 24 hours between Diazepam Rectal Gel and a placebo. The y-axis represents the probability of no seizure, while the x-axis shows time in hours. The graph indicates a higher probability of no seizure with Diazepam Rectal Gel compared to placebo throughout the 24-hour period.*

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A survival curve graph comparing the probability of no seizure over time (hours) between Diazepam rectal gel and placebo groups. The Y-axis represents the probability of no seizure, and the X-axis represents time in hours, showing higher seizure-free probability with Diazepam rectal gel over 12 hours.*

FDA Label Image

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Label for Diazepam Rectal Gel 10 mg Delivery System shows warnings for pharmacists about dial and lock dose syringes prior to dispensing. It includes instructions emphasizing the pharmacist must dial and lock the correct prescribed dose, and cautions about not dispensing until both syringes have been dialed and locked. The label indicates this is a rectal gel dosage form with adjustable syringes containing lubricating jelly, manufactured by Zydus Pharmaceuticals USA Inc. Available doses shown are 5 mg, 7.5 mg, and 10 mg.*

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Diazepam Rectal Gel 20 mg Delivery System label displaying instructions primarily for pharmacists to dial and lock dose syringes prior to dispensing. It includes warning messages such as 'Once locked, cannot be unlocked,' and reminders to instruct caregivers/patients about dose confirmation. The label notes that the system contains two pre-filled, adjustable dose syringes for rectal delivery with lubricating jelly and usage instructions. The labeler is Zydus Pharmaceuticals USA Inc. and the NDC is 70710-2080-2.*

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Pharmacist instructions for Diazepam rectal gel delivery system show a four-step process: 1) Hold the syringe by the barrel without removing the cap; 2) Adjust the dose by turning the cap while viewing the dose window; 3) Lock the dose by pushing the locking ring upward until it shows 'READY'; 4) Repeat for the second syringe and return both to the case. The card advises discarding it after use and confirms the dose before leaving the pharmacy.*

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2.5 mg Container Label (587ad24b 6edd 4cd1 9995 3d12b42c0c0e 09)

Label for Diazepam Rectal Gel 2.5 mg, a human prescription drug in gel dosage form for rectal use. The label includes storage information, Rx-only designation, and distributor details for Zydus Pharmaceuticals USA Inc. It features the NDC 70710-2078-1 and a barcode with the Zydus logo.*

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2.5 mg Carton Label (587ad24b 6edd 4cd1 9995 3d12b42c0c0e 10)

Diazepam Rectal Gel 2.5 mg is shown in a foldable carton label for a rectal delivery system. The label displays the product name, strength, dosage form (gel), route (rectal), and mentions it is for rectal administration only. It includes information about the twin pack pre-filled rectal delivery systems with lubricating jelly. The labeler is Zydus Pharmaceuticals USA Inc. The packaging has barcodes and storage instructions.*

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2.5 mg Carton Label-2 (587ad24b 6edd 4cd1 9995 3d12b42c0c0e 11)

Unfolded packaging label for Diazepam rectal gel by Zydus Pharmaceuticals USA Inc. The design includes illustrations of a dosing syringe on two panels. Text on one panel lists contents of a Twin Pak: two dosing syringes, two packets of lubricating gel, and an administration instructions sheet. The label has measurements for folding and gluing guides but does not display specific dosage strength or volume in the visible text.*

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Text header displaying the product name 'Diazepam Rectal Gel' in bold black font. To the right, there is a stylized circular logo design with the letters 'Z' and 'V' intertwined, representing the labeler. The image appears to be part of a product information or labeling page for Diazepam rectal gel.*

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Diazepam Rectal Gel 2.5 mg/0.5 mL label from Zydus Pharmaceuticals USA Inc. The label displays dosage form and strength information clearly, indicating the medication is intended for rectal administration.*

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Diazepam 10 mg/2 mL gel in a clear plastic syringe with blue cap and labeling. The label shows the proprietary name Diazepam, strength 10 mg/2 mL, dosage form gel, and route rectal. The labeler is Zydus Pharmaceuticals USA Inc. and the syringe contains 2 mL of gel.*

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Diazepam Gel 10 mg/2 mL rectal gel unit dose, supplied in a white plastic applicator with a blue cap. The label on the applicator identifies the active ingredient Diazepam, dosage strength, and administration route. The product is labeled by Zydus Pharmaceuticals USA Inc.*

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Diazepam 10 mg/2 mL rectal gel packaging label from Zydus Pharmaceuticals USA Inc. The box includes the product name, strength, dosage form as a rectal gel, and manufacturer information. The label includes usage instructions and warnings in small print.*

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Diazepam rectal gel packaging label showing the Diazepam 2.5 mg/0.5 mL strength. The label includes the product name Diazepam, dosage form GEL, and the nasal route is not mentioned here but is known as rectal. The labeler is Zydus Pharmaceuticals USA Inc. The box displays NDC number and dosing instructions.*

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Diazepam rectal gel 2.5 mg/0.5 mL in a single-use prefilled syringe type package. The carton shows the proprietary name Diazepam, specifies the gel dosage form and rectal route, with a 0.5 mL syringe length, labeled by Zydus Pharmaceuticals USA Inc.*

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Label for Diazepam Rectal Gel 10 mg Delivery System by Zydus Pharmaceuticals USA Inc. The label indicates that the gel is for rectal administration only, prescription use, storage instructions between 20°C to 25°C with permissible excursions, and warnings to keep out of reach of children. It also includes a barcode and distributor information.*

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A chart with two side-by-side tables labeled 'Seizure Before Diazepam Rectal Gel' and 'Seizure After Diazepam Rectal Gel.' Each table features columns for Time, Seizure Type, and Number of Seizures, designed to record seizure details before and after treatment.*

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10 mg Base Paper Tray (587ad24b 6edd 4cd1 9995 3d12b42c0c0e 13)

The image shows the packaging label for Diazepam Rectal Gel 10 mg Delivery System by Zydus Pharmaceuticals USA Inc. The label includes a syringe illustration with a dose display window and green READY band. It notes administration is rectal only and prescription required. Instructions for caregivers, storage conditions, and a barcode are also visible.*

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A data table with two sections titled Seizure Before Diazepam Rectal Gel and Seizure After Diazepam Rectal Gel. Each section includes columns for Date, Time, Seizure Type, and Number of Seizures, with corresponding blank lines for entering information.*

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Pdp-20mg (587ad24b 6edd 4cd1 9995 3d12b42c0c0e 14)

Label for Diazepam Rectal Gel 20 mg Delivery System by Zydus Pharmaceuticals USA Inc. The label indicates it is for rectal administration only and prescription use. It includes storage instructions (20°C to 25°C with permitted excursions) and safety warnings to keep out of reach of children. The label also advises not to cover the window with the prescription label and includes the NDC and distributor information.*

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20 mg Base Paper Tray (587ad24b 6edd 4cd1 9995 3d12b42c0c0e 15)

Packaging label for Diazepam Rectal Gel 20 mg Delivery System by Zydus Pharmaceuticals USA Inc. The label shows a syringe with a dose display window and green "READY" band. It specifies rectal administration only and prescription use (Rx only). Multiple available dose options from the delivery system are colored and listed: 20 mg, 17.5 mg, 15 mg, and 12.5 mg. The label also includes caregiver instructions, storage information, and a barcode.*

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Lubricating Jelly (587ad24b 6edd 4cd1 9995 3d12b42c0c0e 16)

Packaging label for a water-soluble lubricating jelly, NET WT 0.1 OZ (3 g), intended for use with Diazepam rectal gel delivery system. The product is non-irritating to skin, tissue, and mucous membranes, labeled by Zydus Pharmaceuticals USA Inc.*

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An instructional diagram of a rectangular Diazepam gel syringe for rectal use, showing the dose display window and a green 'READY' band to confirm before administration.*

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Text panel providing contact information for Diazepam Rectal Gel, including a phone number for general product information and an additional resource contact for the Epilepsy Foundation with phone and website details.*

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An instructional diagram depicting step-by-step usage of Diazepam gel for rectal administration. It shows positioning the patient on their side, preparing the medication and syringe, removing the syringe cap, lubricating the rectal tip, turning the patient to face the caregiver, bending the leg to expose the rectum, and separating the buttocks for administration.*

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Instructional illustration showing steps for rectal administration of Diazepam Rectal Gel. It includes inserting the syringe tip into the rectum, counting to three while pushing the gel in, removing the syringe, and holding the buttocks to prevent leakage. It also advises positioning the person on their side after administration. Disposal instructions for the syringe plunger and used materials are also shown.*

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This is a drug facts text panel for Diazepam Rectal Gel providing instructions to call for emergency help if seizures continue 15 minutes after administration or if seizure behavior or person's condition worsens. It includes spaces to note local emergency, doctor, and emergency squad contact numbers, as well as the time and dose of Diazepam Rectal Gel given.*

* 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.