The vial labels may seem ordinary, but they are important in product safety. Choosing the wrong vial labels may result in serious consequences. Are you currently looking for the appropriate vial labels for your product? This article will provide a complete introduction to vial labels and help you choose the right vial labels.
What Are Vial Labels?
A vial label refers to the label attached to small cylindrical containers such as medicine bottles, sample bottles, and vials. These containers are typically small in size and are widely used in medicine, laboratories, health supplements, cosmetics, biotechnology, and so on.
Types of Vial Labels
Classified by Labeling Method
Wrap-around Labels
This is the most common form of vial label. The label wraps around the entire bottle, providing a 360° display area for information. This labeling method is mainly used for vials, and the label may include special liquid level markings, so it must be precisely fitted.
Pressure-sensitive Labels
Pressure-sensitive labels can be simply pressed onto the surface for easy application. No glue or tools are required. They are suitable for various bottles, tubes, and ampoules.
PS Labels are convenient to use, cost-effective, and have good moisture resistance. However, it may lose its stickiness when exposed to dust and dirt, and it is not suitable for all surfaces.
Shrink Sleeve Labels
Shrink sleeve labels are made of plastic. When heated, they shrink and fit snugly to the shape of the container, making them suitable for containers of various shapes.
In-mold Labels
In-mold labels are integrated with the bottle body during the container molding process, and the labels are almost inseparable from the container. In-mold label is unlikely to come off or curl, and it has good tamper-resistance properties. If you want the label to remain permanently on the bottle, this is a good choice.
Classified by Function
Common Labels
The Common Label displays basic information such as the name of the drug, dosage, concentration, batch number, and expiration date.
Anti-counterfeiting Labels
Holographic Anti-counterfeiting Label
Holographic anti-counterfeiting labels are one of the most widely used anti-counterfeiting technologies. The holographic images on the labels can display 3D images that change with the light, enabling quick and intuitive verification of the authenticity of the products.
Peelable Anti-counterfeiting Label
The peelable anti-counterfeiting label is also a common form. The surface of the label is covered with a peelable coating, beneath which there is a set of unique anti-counterfeiting verification codes. After the end-user peels off the coating, they can verify the authenticity of the product by scanning the code with a mobile phone or entering the verification code in the brand’s database.
Tamper-evident Labels
Tamper-evident labels are specifically designed to identify whether the packaging has been opened or tampered with. When you remove the label from the container, the structure of the label undergoes irreversible physical damage and displays clear visual marks. The most common mark is the word “VOID”.
Security Labels
Security labels integrate technologies such as RFID and NFC, enabling drug tracking and anti-counterfeiting, and ensuring the supply chain security.
The RFID label is embedded with a microchip and an antenna. It can read the unique identification code stored within the label without physical contact.
NFC tags are more suitable for use in proximity. Just touch the label with your smartphone to obtain complete information about the medicine. It includes the authenticity, reading the electronic instructions, and so on.
Thermochromic / Temperature-sensitive Labels
Thermochromic labels are a type of special label containing thermochromic color-changing materials. They can visually indicate by color changes whether the product has been exposed to temperatures outside the recommended storage range. If your product has high requirements for storage temperature, you can use this type of label.
Cryogenic Labels
Cryogenic labels are a special type of label specifically designed for extremely low-temperature environments. It can withstand the extremely low temperatures ranging from -196°C to -80°C. It can remain no-peeling, undamaged, and unchanged in a super-low temperature refrigerator and during dry ice transportation.
Multi-layer Labels
A multi-layer label consists of two or more layers of label structures. Its typical structure is that multi-layer label sheets are connected by hinges or edge gluing. Users can unfold the labels like turning pages or tearing pages to read the information on the underlying layers.
If your product instructions are lengthy, you could consider using the multi-layer label.
Low-leachability Labels
Low-leachability Labels are a type of label specifically designed for liquid pharmaceutical containers made of non-glass materials. The adhesive component of this label will not penetrate through the container wall and contaminate the liquid, nor will it alter the composition of the liquid.
Classified by Material
Paper Labels
Paper labels have the lowest cost, high printing clarity, and wide application. However, it has poor wear resistance and limited chemical resistance. It is prone to wrinkling, expansion, and failure in humid or condensing environments. This label is suitable for general indoor labeling and products with a short lifecycle.
Synthetic Film Labels
Synthetic film labels have the most comprehensive performance and are the most widely used among vial labels. There are three common materials for your reference.
PET Labels
The PET labels have excellent heat resistance. When other films may melt or deform, PET labels remain stable. The PET labels also possess outstanding chemical resistance, durability, and tensile strength.
PP Labels
PP labels have excellent moisture resistance, but the performance of PP labels is not as good as that of PET at extremely high temperatures or in strong solvent environments. PP labels are commonly used in high-speed transportation and consumer products, as well as in chemical and industrial packaging.
PVC Labels
PVC has good flexibility, which enables it to expand and contract along with the substrate as the temperature changes. It is suitable for curved surface labeling and outdoor equipment. PVC labels perform well when exposed to ultraviolet rays and possess excellent outdoor durability.
Key Requirements of Vial Labels
US FDA Regulations
- 21 CFR 201: This regulation stipulates the content and format requirements for the labels of prescription drugs and over-the-counter (OTC) medications. It stipulates that the labels must accurately state the approved indications, dosages, and contraindications of the drugs, and must not contain misleading information. The information must be stated clearly.
- Drug Facts label format: For OTC drugs, the FDA requires a standardized Drug Facts format. The text must be at least 6 font size, and the layout must be legible at arm’s distance. Contents must follow the sequence: active ingredients → indications → usage instructions → warnings → inactive ingredients, etc.
- DSCSA: It was fully implemented in November 2024, requiring all prescription drugs to achieve full serialization and traceability.
EU Regulations
- EU GMP (EudraLex Volume 4): Covers requirements for aseptic packaging and regulations for clean production environments.
- EU FMD: All pharmaceutical packaging must be equipped with 2D barcodes and tamper-proof seals.
- EU MDR: The labels must be in the official languages of each member state. It clearly stipulates that the labels must indicate “medical device” or mark UDI (Unique Device Identifier).
International Standard
- ISO 15378: This is a specialized standard for the quality management system of primary packaging materials for pharmaceuticals. While encompassing all the requirements of ISO 9001:2015, it also adds GMP (Good Manufacturing Practice for Pharmaceuticals) requirements specifically for primary packaging materials of pharmaceuticals.
- ISO 13485: This is a certification for the quality management system of medical devices. And it is an important qualification for medical label manufacturers.
- ISO 10993: This standard for medical device biological evaluation is applicable to the assessment of the biocompatibility of labeling materials with drugs or the human body.
Applications of Vial Labels
Medical Industry
This is the main application area of vial labels. Vial labels are mainly used for labels of injectable drugs, biologics, and vaccines, labels of vials of prescription drugs and OTC drugs, and sterile and cleanroom labels for clinical supplies.
Laboratory and Life Sciences
Vials and test tubes are the most basic containers in the laboratory. Laboratory labels need to meet the requirements of being small, clear, and durable. They also need to be resistant to extreme conditions such as low temperatures of liquid nitrogen, chemical exposure, and high-pressure sterilization.
Cosmetics and Personal Care
Vial labels can also be used for small-capacity cosmetics such as essential oil bottles and small samples of skin care products. The stickers must not only meet the aesthetic requirements of the brand, but also be resistant to oil, water, and scratching.
Diagnostic Reagents and Biological Samples
It is generally used as labels for blood collection tubes, sample cryovials, and small bottles in test kits. This vial sticker has high requirements for low-temperature tolerance and chemical corrosion resistance.
Health Supplements and Nutritional Products
Labels for small-sized packaging, such as vitamin bottles and supplement bottles.
Chemicals and Industrial Applications
Labels for packaging laboratory chemicals and small-dose reagents for industrial use.
FAQ
If Cosmetics Are Exported to the United States, What FDA Requirements Do the Vial Labels Need to Meet?
It is necessary to comply with the labeling regulations issued by the FDA under the FD&C Act and the FP&L Act. According to 21 CFR Part 701, cosmetic vial labels must include a list of ingredients(using INCI international cosmetic ingredient naming, arranged in descending order of content), net content declaration, product name, company name, and address.
The font must be clear and contrast sufficiently with the background to ensure that consumers can read it properly.
What Information Needs to Be Indicated on vial labels in the Laboratory and Biological Sample Bank?
According to internationally recognized quality management systems (such as ISO 20387:2018), sample container labels should be able to support the entire traceability of the samples. Laboratory vial labels usually should include basic information such as the unique identification number of the sample, the name or type of the sample, the collection or receipt date, and the operator’s identification.
What CLP Regulations Need to Be Met When Vial Labels for Essential Oils or Aromatherapy Are Exported to the EU?
According to the requirements of CLP, if a product is determined to be hazardous, the label must include the product identifier, hazard pictogram (such as flammable), signal word (“Danger” or “Warning” ), hazard description, precautionary statement, and supplier information. The line spacing must be no less than 120% of the font size. The minimum area of the hazard pictogram must not be less than 1 square centimeter.
If the Vial Labels Need to Be Stored in the Warehouse for a Long Time, What Kind of Materials and Structures Would Be More Stable?
The PET film vial labels have excellent dimensional stability and resistance to humidity and heat. They can be stably stored for about 2 years in a warehouse with controlled temperature and humidity. The labels should be stored in their original packaging in a sealed state, avoiding direct sunlight and extreme temperature fluctuations.
It is recommended to use them within 18-24 months to achieve the best labeling performance. Old labels beyond the recommended period should undergo small-scale adhesion tests before use.
Do Vial Labels Used for Chemicals and Industrial Purposes Need to Comply with GHS Standards?
Yes. Vial labels for hazardous chemicals are generally standardized globally according to GHS. According to GHS, hazardous chemical vial labels must contain six core elements: product identifier (chemical name), hazard pictogram, signal word (“Danger” or “Warning”), hazard statement (H statement), precautionary statement (P statement), and supplier information (name and phone number).
Final Thoughts
Liyantian is a professional vial label printing factory. Our labels apply to various medicine bottles and can meet the requirements of medical transportation and storage. We also offer comprehensive customized services. No matter what kind of vial labels you need, please feel free to contact us.
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