• Content of label
• Types of labels
• Legal requirements for labeling
• Adhesives used for labeling
• Packaging inserts
• Packaging outserts
• Labeling machinery
• A label is piece of paper, polymer cloth, metal,
or other material affixed to a container or
article, on which is printed a legend,
information concerning the product, addresses,
etc.,. Information printed directly on a container
or article can also be considered labeling.
• Labeling is manual or electromechanical
process of attaching “label” to the correct
particular product or packaging or service.
– Contain a summary of essential scientific
information for the safe and effective use of the
– Be informative and accurate and neither
promotional in tone nor false or misleading
– Based on data derived from human experience. No
implied claims or suggestions of drug use may be
made if there is inadequate evidence of safety or
lack of substantial evidence of effectiveness
– Be updated when new information becomes
available that causes the labeling to become
inaccurate, false, or misleading
Types of labels
Paper label :
• it is an economical label method.
• the disadvantages of this material is its appearance of being tacked on.
• Vulnerable to scuffing, wrinkling, blistering and lifted or curled edges.
• Foil labels are always laminated with paper so that they work properly in
labeling machine. It is done so because of the dead fold character of the
• Heat sensitive coating are used.
• The appearance is better than paper label.
• Sleeve labels are used on cylindrical surfaces like bottles etc.
• It is also pilfer evident when scaled atop the closure of the bottle.
Types of labels based on adhesives:
1. Cold glue: The lowest cost glue is the starch or
dextrin types. They are fairly fast drying but they
are not waterproof or ice proof when immersed.
2. Pressure sensitive or self adhesive: A pressure
sensitive label is a material, which has adhesive
glue on the backing. When pressure is applied it
will adhere to most surfaces.
3. Heat seal labels: Heat seal labels are made by
applying a combination of heat and pressure. These
labels are used for tamper evident and permanent
• All mandatory information on food labels must be shown in
both official languages, i.e., regional and English.
• In addition, all information on the labels may be in one
official language only.
• Designed to help alert handlers that extra care is required,
these markings are available for messages such as Keep
from Freezing, This End Up, Do Not Stack and Fragile.
• These labels are designed to catch the eye of any personnel
that comes within range of your shipments.
• Describes something about the object that carries the
• Originally barcodes systematically represented data by
varying the widths and spacing’s of parallel lines, and may
be referred to as linear or one-dimensional (1D).
• Later two-dimensional (2D) codes were developed, using
rectangles, dots, hexagons and other geometric patterns in
two dimensions, usually called barcodes although they do
not use bars as such.
Radio frequency labels:
• Radio-frequency identification (RFID) uses electromagnetic
fields to automatically identify and track tags attached to
objects. The tags contain electronically stored information.
• Passive tags collect energy from a nearby RFID reader's
interrogating radio waves.
• Active tags have a local power source such as a battery and
may operate at hundreds of meters from the RFID reader.
Structured product label:
The primary purpose of SPL is to
support electronic distribution and electronic update
over the life cycle of the drug. SPL is to be the basis
of a broader initiative that will include automated
distribution of Labelling content from the sponsor,
through the FDA, to a central repository operated by
the National Library of Medicine.
In mould label:
• In-mould labelling is the use of paper or plastic labels
during the manufacturing of containers by blow molding,
injection molding or thermo forming processes.
• The label serves as the integral part of the final product,
which is then delivered as pre-decorated item.
• This creates the advantage that scrap bottles produced in the
molding process can be recycled, without the need for label
removal prior to recycling.
Legal requirements for labeling:
1. The name of preparation
2. Strength and dosage form
4. Instructions for the use.
5. Precautions & warnings.
6. Registration number.
7. Batch number.
8. Manufacturing & Expiry date.
Adhesives used in labeling
• Permanent adhesive
• Peelable adhesive.
• Freeze or frost fix.
• Permanent – typically not designed to be removed
without tearing the stock, damaging the surface or using
solvents. The adhesion strength and speed can also be
varied. For example, full adhesion can be nearly instant,
or the label can be almost removable for a short period
with full adhesion developing in minutes or hours.
(known as repositionable adhesives).
• Peelable – adhesion is fairly strong and will not fall off
in normal circumstances, but the label can be removed
relatively easily without tearing the base stock or
leaving adhesive behind on the old surface. The
adhesive is usually strong enough to be applied again
elsewhere. This type is frequently known as
“removable”. There are many different types of
removable adhesives, some are almost permanent, some
• Ultra peelable – designed principally for use on
book covers and glass, when removed these
adhesives labels do not leave any residue. Adhesion
is weak and only suitable for light duty applications.
Normally these labels have very little adhesion to
anything once they’ve been removed.
• Freeze or frost fix – Most permanent and peelable
adhesives have a service temperature limit of -10oc,
where as freezer (otherwise known as frost fix)
adhesive have a service temperature -40oC and are
suitable for deep freeze use.
• A package insert is a document provided along with
a prescription or over-the-counter medication to provide additional
information about that drug.
• Package inserts follow a standard format for every medication and
include the same types of information.
• In addition to the obvious use of inclusion with medications, package
inserts have been used or provided in other forms
• Patient information is, understandably, usually generated initially in
the native language of the country where the product is being
developed. This leads to inconsistency in format, terminology, tone,
• Package outserts are known as circulars, brochures, monographs and
patient package inserts.
• Pharmagraphics prints and folds package outserts, which are applied
to bottles during solid-dose filling operations.
• Outserts are used on automatic packaging lines and are folded to a
variety of finished sizes.
• Outserts can be designed as an RTA style (right angle outserts) or
• Package outserts are supplied in tray packaged and mechanically
counted and labeled for full lot traceability.
• Four different labelling systems possible on one machine.
• Compact building size via exchange of labelling stations
that are not needed.
• Optimal access for operation and maintenance.
• Variable container turning via servomotors
• Quick installation and start-up.
AUTOMATIC LABELING MACHINE
• Model : AB2000
• Power supply : 220V; 50Hz; 500W
• Applied material : Adhesive label
• Label size : L (15-300) mm X H (50-130)
• Package dimension : Dia ₵ 20~ ₵ 80; H (25~300)
• Label speed : 0~75pcs/min (only one label);
0~50pcs/min (two labels)
• Optional : 1.Code printer;
2. Bottle trimmer ₵ 800mm
Increased information on the labels is influenced by:
• Health and safety issues: More and detailed
information is required on the product, from the point
of view of human health, safety of the consumer and
more comprehensive contents / ingredients listings.
• Better inventory control.
• Much more environmental pressure, particularly on
• National and international legislations.
• Growing internationalization of the label and labelling
market leading to more languages being used.
• Increased problems with tampering, look-alikes and
the counterfeiting of goods.
• Labeling is one of the most important technology
and essential in pharmaceutical industries.
• Labeling is a intended as a guide both for medical
practitioners and patients.
• It will avoid the misuse and mishandling by
1. Atul Kaushik, Bhaskar Chaurasia, Virendra Dhakar,
Textbook of Pharmaceutical Technology, Edition-1,
2. Pharmaceutical packaging technology By U.K.Jain,
D.C.Goupale, and S.
3. Pharmaceutical packaging technology By D. A.
Dean, E. R. Evans, & H. Hall Pg.no.582-613.