

|
DENTSPLY Pharmaceutical
1301 Smile Way
York, PA 17404
Customer Service
Phone: 1-800-989-8826
Fax: 1-800-278-4344
Email: infopharma@dentsply.com
|
|
Home > FAQ > Packaging Features & Benefits
Cartridge Information
Cartridges are packaged in unique blister trays which minimize the risk of breakage.
Cartridges feature siliconized plungers which allow for smooth movement and precise control
Blister Pack Benefits
|
 |
The blister tray keeps cartridges organized while only
exposing 10 of them at a time. Each tray is imprinted with an easily identified lot number and expiration date.
Cartridge Label - Breakage
The cartridge labels for DENTSPLY Pharmaceutical local anesthetics each have an
easy-to-read, "shatter-protective" Mylar label. The Mylar label reduces the hazard of
loose glass fragments in case of breakage from mishandling or extreme pressure.
|
The ADA Council on Scientific Affairs Acceptance 2% Xylocaine® DENTAL (lidocaine HCl Injection, USP), 2% Xylocaine® DENTAL (lidocaine HCl and epinephrine Injection, USP), 2% Xylocaine® DENTAL (lidocaine HCl and epinephrine Injection, USP), 3% Polocaine® DENTAL (mepivacaine HCl Injection), 2% Polocaine® DENTAL (mepivacaine HCl and levonordefrin Injection), 4% Citanest® Plain DENTAL (prilocaine HCl Injection, USP), 4%
Citanest® Forte DENTAL (prilocaine HCl and epinephrine Injection, USP) is based on its finding that the products are an effective injectable local anesthetics for oral use when used as directed.
In 2002, the ADA Council on Scientific Affairs notified manufacturers of ADA accepted local anesthetics of a new uniform cartridge color-coding system for identifying injectable local anesthesia products. This ruling applies to all injectable anesthetics and local anesthetic/vasoconstrictor combinations that participate in the ADA Seal of Acceptance program. The DENTSPLY Pharmaceutical line of local dental anesthetics is currently in compliance with this new system. All other manufacturers participating in the ADA Seal of Acceptance program were expected to adopt this new system by June 2003.
The purpose of this change is to establish uniform color codes, which will assist practitioners in identifying the type of anesthetic in the cartridge. However, dentists are still encouraged to read the cartridge label and not rely solely on the cartridge color as a means of identifying the anesthetic.
The new look should adhere to the following guidelines:
- A 3 mm wide band of color shall be placed on the anesthetic cartridge. Band of color should be placed 15 mm from the stopper end of the cartridge.
- End cap of cartridge may be either color-coded to follow the ADA Color Coding System, or it may be given a silver color.
- The stopper should not be color-coded.
- Lettering on the cartridge should be durable and should follow the FDA labeling guidelines (headings to be at least 8 point type and text to be at least 6 point type).
The color code format for the band as stated on the chart below:
|
Product
Lidocaine 2% with Epinephrine 1:100,000
Lidocaine 2% with Epinephrine 1:50,000
Lidocaine Plain
Mepivacaine 2% with Levonordefrin 1:20,000
Mepivacaine 3%
Prilocaine 4% with Epinephrine 1:200,000
Prilocaine 4%
Bupivacaine 1.5% with Epinephrine
Articaine 4% with Epinephrine 1:100,000
|
PMS Color Code (Pantone Matching System)
Red: 185, 186, 199 or 200
Green: 347, 348, 355 or 356
Light Blue: 347, 348, 355 or 356
Brown: 471, 477, 478, 498 or 499
Plain Tan: 466, 467 or 468
Yellow: 108, 109, 110, 115 or 116
Plain Black
Blue: 300 or 301
Gold: 871, 872, 873, 874 or 875
|
|