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Diazepam Gel
Product Images NDC 68475-804
View Photos of Packaging, Regulatory Labels, and Product Appearance
Product Visual Gallery
This gallery contains 31 technical images submitted to the FDA as part of the official labeling for Diazepam (NDC 68475-804). 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.
Product Images & Figures Index
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This text appears to be instructions regarding a medication dispenser for rectal use. It includes guidance for pharmacists and caregivers/patients to ensure the correct dose is dialed and instructions are reviewed before leaving the pharmacy. The medication dispenser mentioned seems to have pre-filled, adjustable dose syringes with lubricating jelly and usage instructions provided by Navinta LLC.*
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This is a description of Diazepam Rectal Gel 20 mg Delivery System, with specific instructions for pharmacists to dial and lock the correct prescribed dose using two pre-filled, adjustable syringes. Caregivers and patients are advised to confirm the correct dose has been dialed before leaving the pharmacy. The product should not be dispensed until both syringes have been dialed and locked. Additionally, the instructions mention that once locked, the syringes cannot be unlocked. The package also contains lubricant jelly and usage instructions.*
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This is a set of pharmacist instructions for the delivery system of Diazepam Rectal Gel. The instructions outline the steps to follow, which include holding, adjusting, and locking the syringe. It emphasizes the importance of confirming the correct dose before leaving the pharmacy, as once locked, it cannot be unlocked. The pharmacist is advised to repeat the steps for each syringe and discard the card once finished. A contact number is provided for any questions.*
2.5 mg Container Label (00e3990f 601b 4527 A60a D6cc6be27ee2 09)
This information is for a medication intended for rectal administration only. The medication should be stored within a temperature range of 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C and 30°C (59°F and 86°F). The package insert should be referenced for prescribing information. The medication is manufactured for Navinta LLC, located at 1499 Lower Ferry Road, Ewing, NJ 08618. Remember to keep the medication out of reach of children.*
2.5 mg Carton Label (00e3990f 601b 4527 A60a D6cc6be27ee2 10)
This text contains information about a rectal delivery system provided by Navinta LLC. It is a twin pack that includes two pre-filled, unit dose rectal delivery systems with lubricating jelly and instructions for use. The pack contains two units for convenient application. The system is designed for rectal administration and must be used as prescribed by a healthcare professional. It is important to note that transferring the drug to another person is prohibited by law unless prescribed for that individual. The size of the system is approximately 50x24 mm.*
2.5 mg Carton Label-2 (00e3990f 601b 4527 A60a D6cc6be27ee2 11)
The text is not-readable.*
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Pdp-10mg (00e3990f 601b 4527 A60a D6cc6be27ee2 12)
This is a description for Diazepam Rectal Gel 10 mg Delivery System. It is a prescription medication for rectal administration only. It includes storage instructions and a caution to keep it out of reach of children. The product is manufactured by Navinta LLC. Please refer to the package insert for more information.*
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This is a comparison of the number and type of seizures before and after using Diazepam Rectal Gel. The data shows three seizures before using the gel but does not provide details about the seizures after.*
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10 mg Base Paper Tray (00e3990f 601b 4527 A60a D6cc6be27ee2 13)
This text contains information about a medication called Diazepam Rectal Gel in a 10 mg delivery system. The medication is prescribed for rectal administration only and is marked as Rx only. The text also provides instructions for using the medication, including steps for confirming the prescribed dose and ensuring the medication is ready for use. The product is manufactured for a specific address listed in Ewing, NJ.*
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This text appears to be a report or log of seizures in relation to the administration of Diazepam Rectal Gel. It records the number and type of seizures before and after the use of the medication. The document seems to be tracking the effectiveness of Diazepam Rectal Gel in managing seizures.*
Pdp-20mg (00e3990f 601b 4527 A60a D6cc6be27ee2 14)
This text provides information about a medication with the brand name "DIEYEETLN T 21K" and a 20 mg delivery system intended for rectal administration. The text instructs to store the medication at a temperature between 20°C to 25°C (68°F to 77°F) with allowed excursions between 15°C to 30°C (59°F to 86°F). It also includes a note to refer to the package insert for product information and to keep the medication out of reach of children. The manufacturer, "Navinta LLC," and their address details are also mentioned in the text.*
20 mg Base Paper Tray (00e3990f 601b 4527 A60a D6cc6be27ee2 15)
This is a description for Diazepam Rectal Gel 20 mg Delivery System manufactured by Navinta LLC. The instructions for caregivers include removing the syringe from the case, confirming the prescribed dose, and ensuring the green "READY" band is visible. The gel contains diazepam and other ingredients like propylene glycol and ethyl alcohol. Caregivers are advised to contact a pharmacist if they have any questions about the usage of this medication.*
Lubricating Jelly (00e3990f 601b 4527 A60a D6cc6be27ee2 16)
This is a water-soluble lubricating jelly with a net weight of 0.10 ounces (3g). It is designed for use with the Diazepam rectal gel delivery system by Navinta LLC. The lubricant is non-irritating to skin, tissue, and mucous membranes.*
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Confirm the dose and green "READY" band are visible in the dose display window.*
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This text provides contact information for obtaining more details and support related to Diazepam Rectal Gel, Rectal delivery system. It includes a phone number (1-609-883-1135) and directs individuals to the Epilepsy Foundation (EF) for additional assistance through their phone number (1-800-EFA-1000) or website (www.efa.org).*
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This text provides instructions on how to prepare a syringe for rectal administration. It includes details on how to position the person on their side, remove the cap from the syringe, lubricate the rectal tip, and expose the rectum for administration.*
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This text provides instructions on how to administer diazepam rectal gel by gently inserting a syringe tip into the rectum and counting to three slowly. It emphasizes proper disposal of used materials and safety measures, including keeping the person on their side.*
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This text provides important information on when to call for help during a seizure emergency, such as if seizures continue 15 minutes after administering Diazepam Rectal Gel or following the doctor's instructions. It advises to call for help if seizure behavior is different, if the frequency or severity of the seizures is alarming, if there are concerns about the person's breathing or color, or if the person is experiencing unusual or serious problems. It also suggests contacting the local emergency number or 911 and provides space to note down the doctor's number, time and dose of Diazepam Rectal Gel given, and information for the emergency squad.*
* These product label images have been analyzed using experimental machine learning. Please verify findings with the primary label text.
