Naloxone Hydrochloride Injection, Usp, Auto-injector Injection, Solution
Product Images NDC 60842-002

12 FDA label images from Kaleo, Inc. · Packaging, Regulatory Labels, and Product Appearance

Product Visual Gallery

This gallery contains 12 technical images submitted to the FDA as part of the official labeling for Naloxone Hydrochloride Injection, Usp, Auto-injector (NDC 60842-002). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.

As provided by Kaleo, 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

Chemical Structure (Naloxone Figure 1)

Chemical Structure (Naloxone Figure 1)
Chemical structure diagram of Naloxone Hydrochloride, showing its molecular framework and functional groups including hydroxyl and ketone groups, along with the hydrochloride component.*
FDA Label Image

Auto-injectors Label (Naloxone Figure 10)

Auto-injectors Label (Naloxone Figure 10)
Flat carton layout for Naloxone Hydrochloride Injection, USP Auto-Injector, 10 mg by Kaleo, Inc. The label includes product name, strength, and manufacturer details. It notes storage conditions, usage for opioid emergencies, and internal information placement for UPC, QR code, lot number, expiration, and serialization. Black vertical strip with Kaleo logo runs along edge.*
FDA Label Image

Device Label (Naloxone Figure 11)

Device Label (Naloxone Figure 11)
Packaging label for Naloxone Hydrochloride Injection, USP Auto-Injector, 10 mg by Kaleo, Inc. The label shows instructions for use, including removing the red safety guard and pressing the black end firmly against the outer thigh for 5 seconds. It includes a viewing window on the red background and warnings to call 911. Storage instructions and manufacturer information are also visible.*
FDA Label Image

Outer Case Label (Naloxone Figure 12)

Outer Case Label (Naloxone Figure 12)
Label for Naloxone Hydrochloride Injection, USP Auto-Injector, 10 mg by Kaleo, Inc. The label is red with white areas for text, showing instructions to pull the device from the case and a viewing window. It states use for opioid emergencies in adults and children 12 years and older, for intramuscular or subcutaneous injection. Storage instructions and manufacturer details are also included.*
FDA Label Image

Figure1a (Naloxone Figure 2)

Figure1a (Naloxone Figure 2)
A line graph comparing mean naloxone concentration (ng/mL) over time (hours) after doses of Naloxone Hydrochloride injection at 2 mg and 10 mg. The plot shows concentration peaks shortly after dosing and gradual decline up to 8 hours, with error bars indicating variability.*
FDA Label Image

Figure1b (Naloxone Figure 3)

Figure1b (Naloxone Figure 3)
A line graph comparing mean naloxone concentration (ng/mL) over time post dose (hours) for Naloxone Hydrochloride injection at 2 mg and 10 mg doses. The 10 mg dose shows a higher peak concentration and a slower decline over 3 hours compared to the 2 mg dose.*
FDA Label Image

Figure A (Naloxone Figure 4)

Figure A (Naloxone Figure 4)
Illustration showing parts of the Naloxone Hydrochloride Injection, USP Auto-Injector 10 mg device before and after removing the outer case. Labels identify the outer case, viewing windows, base, safety guard, and needle end. Instructions include pulling off the red safety guard, placing the black end against the thigh, pressing firmly for 5 seconds, and calling 911. The red and white auto-injector is marked for opioid emergency use and provides injection instructions on the device.*
FDA Label Image

Figure A (Naloxone Figure 5)

Figure A (Naloxone Figure 5)
Illustration showing hands removing the outer case from a Naloxone Hydrochloride Injection, USP, Auto-Injector device. The figure is labeled 'Figure B - Remove Outer Case' and depicts the step of peeling back the outer cover for use preparation.*
FDA Label Image

Figure A (Naloxone Figure 6)

Figure A (Naloxone Figure 6)
An instructional diagram showing a hand holding the Naloxone Hydrochloride Injection, USP, Auto-Injector and another hand removing the red safety guard. The image is titled 'Figure C – Remove Red Safety Guard' and uses an arrow to indicate the removal direction.*
FDA Label Image

Figure A (Naloxone Figure 7)

Figure A (Naloxone Figure 7)
Instructional illustration showing the administration of Naloxone Hydrochloride Injection, USP, Auto-Injector. The top panel demonstrates buddy administration by placing the injector firmly on the outer thigh and holding for 5 seconds. The bottom panel demonstrates self-administration by placing the injector on the outer thigh oneself and holding for 5 seconds. Both panels include a stopwatch graphic emphasizing the 5-second hold time.*
FDA Label Image

Figure A (Naloxone Figure 8)

Figure A (Naloxone Figure 8)
Naloxone Hydrochloride Injection, USP, Auto-Injector 10 mg label with instructions. The label highlights a viewing window with a red indicator, a base locked indicator, and a needle retracted marker. It includes stepwise use instructions and a prompt to call 911. The label is predominantly white and red.*
FDA Label Image

Figure A (Naloxone Figure 9)

Figure A (Naloxone Figure 9)
Top view of a Naloxone Hydrochloride Injection, USP, Auto-Injector label showing expiration date placeholder, a barcode, and lot number on a purple and white background. The auto-injector has a red base with a black triangular symbol. The label includes small printed text on the sides.*

* 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.