Pharmaceutical labels are highly regulated. Both prescription and over-the-counter products require specific information to inform the consumer. However, many products, like anticavity toothpaste, sunblock, hand sanitizer and even rubbing alcohol qualify as pharmaceuticals. It’s important to ensure you understand labeling requirements for each product you manufacture or package.
Here’s an overview of which information is required, and how Quadrel’s labeling systems can meet the challenge.
Basic pharmaceutical labeling requirements
No matter what kind of product you’re selling, the label needs to stay on the container and legible throughout its lifespan. In other words, it needs to last at least as long as the expiration date.
When selecting a label style and material, choose a strong adhesive with water and light resistance.
Required information for pharmaceutical labels
Prior to current legislation, the industry lacked specific guidelines on placement, legibility and what kind of information must be included. Consumers often missed important dosage and side effect information. The FDA enacted guidelines in 2002, which remain in place today.
Your pharmaceutical labels must include:
- Active ingredients
- Allergic reaction information
- Drug facts
- Inactive ingredients
- Product name
- Purpose and use
- Three-section National Drug Code (NDC) label
Best practices and considerations for pharmaceutical labels
Drug manufacturers have to be particularly cautious and keep product labeling runs separated during the production and application process. This is usually accomplished by labeling different products on different lines, or on different days.
Next, manufacturers must consider drug counterfeiting measures. This can be done in several ways: randomized tracking numbers and barcodes (required for prescription drugs), tamper-proof seals and watermarks can make it harder for counterfeiters to copy or reuse labels. Print-and-apply machines are particularly good for randomized tracking codes, and shrink-sleeve wraps can add a tamper-proof seal.
It’s also important to consider how large your label is. Because pharmaceutical labels require so much information, it’s best to use a high-quality machine that can print legible small text. Alternatively, you can opt for expandable labels, which remain attached to the product. Consumers can expand the label to read additional instructions or recommendations.
Quadrel pharmaceutical labeling solutions
Quadrel offers several labeling solutions, specifically designed with pharmaceutical labeling in mind. Whether you’re labeling syringes, vials, ampules or bottles, these precision labeling systems can accurately label hundreds of products per minute. This popular model includes laser imprinting of date and lot codes, making it easy to comply with drug labeling guidelines.
Depending on your specific labeling requirements, you may also choose shrink-sleeve wrapping. Shrink-sleeve labels not only provide tamper-evident protection, but extra label space. When your product requires lengthy information, the 360-degree design potential ensures that you can fit the required information on a single outer layer. Shrink-sleeve labels further add stability and strength to the packaging, ensuring fewer products are lost during shipping.
Whatever pharmaceutical product you manufacture, Quadrel’s labeling systems can deliver exactly what you need. Not sure which labeling machine is right for your line? Our team would be happy to discuss options in depth, or come up with a custom solution. Reach out today to get started.