Pharmaceutical Labeling & its requirement

1. Pharma Labels
Dr. Anil Pethe

2. Label- carrier of information
• Product identity
• Corporate image and sales appeal
• Pack contents
• Legal and moral warnings
• Bar codes
• Security
• Identity and address of manufacture
• Instructions for use
• Information on handling
• Promotional information

3. Label fundamentals
• A good design
• Well printed
• Best paper for the purpose
• Features critical for machine application
• Surface finish
• Print requirements
• Suitable adhesive

4. Labeling Options
a) Embossing
b) Paper label on tabs
c) Direct printing on tabs
d) Conventional Labels

5. Embossing- Engraved Molds
•A mirror image of information is engraved on the
surface of a mold’s cavity.
•Small vacuum ports on the mold surface pull in
the soft plastic embossing the container.

6. A) Embossed Labeling

7. Embossing
Pros
• No leachables
• Ensure each unit is traceable
• Labels can not be removed
• Ensures 100% labeling of containers
• No maintenance of label inventories
Cons
• Difficult to read on clear containers

8. b) Paper Labels on Tabs
• The mold is designed with a
tab, or flag on the tail or the
cap.
• Tab is a solid surface providing
space for paper labels

9. Paper label on Tab
Pros
• Greatly reduces potential leaching into the
solution
• Clearer to read
Cons
• Potential leaching of label adhesive into solution

10. c) Direct Printing on Tabs
• Ink jet printing on
tabs with barcodes,
and product
information

11. C) Direct printing on the Tab
Pros
• Allows for barcode printing on line
• Greatly reduces potential leaching into the solution
• Eliminates potential leaching from paper labels
• Clearer to read
Cons
• Potential leaching into solution

12. d) Conventional Labeling

13. Types of paper labels
• Plain paper
• Pregummed paper
• Heat sensitive labels
• Pressure sensitive or self adhesive

14. Plain paper labels
• Most widely used for glass
• Application can be by
hand,400-600per hour
semiautomatic 3,600 per hour
fully automatic methods 3,500-60,000
Adhesives
Problems of curl

15. Pregummed labels
Paper is precoated with dextrine or gum arabic
• Labels are clean to apply
• Ideally suited to small runs
• Provide good adhesion
Large labels are difficult to apply
Lack of flexibility
Due to high tack can not be adjusted readily once on
the item to which they are being applied.

16. Heat sensitive labels
• Based on synthetic resins
• Applied after the activation of thermoplastic
coatings by the use of heat
• Adhere to wider range of materials
• Storage of thermoplastic material
• During activation temperatures above 100o
C are
used.

17. Types of heat sensitive labels
• Instant tack labels
• Delayed tack labels

18. Instant tack labels
• Sets immediately the source heat is removed.
• May be applied by hand, semi-automatically or
automatically
• More sophisticated heating systems
• Can be more expensive
• Less cleaning time
• Special usage- seals overwraps, header labels
• Not used for bottle or can labeling

19. Delayed tack labels
• Tacky state remains for some time after the source
of heat is removed
• More versatile
• Application to bottles, tinplate plastics, coated or
laminated surfaces

20. Advantages
• No cleaning down, no wastage of adhesive
• Shorter setting up time
• Adhesion to a wider range of surfaces
• Provide a high standard of cleanliness.

21. Pressure sensitive labels
• Consist of a suitable label paper coated on the
reverse side with a tacky adhesive which is in contact
with a backing paper
• Adhesives may be temporary,
semi-permanent, permanent

22.  Structure
Facing material
Key coating material
Silicone release backing

23. Case Studies

24. Recall: Alka-Seltzer Plus Day &
Night Cold Formula Liquid Gels
• Bayer has recalled one product lot of the combination
package of Alka-Seltzer Plus Day & Night Cold Formula
Liquid Gels.
• The labeling on the foil blister card of certain packages
within the lot was printed with the label reversed. The
product was sold at retail outlets throughout the United
States.
• Package size: 20 liquid filled capsules per carton (12 day
formulation capsules and 8 night formulation capsules)
• The risk: The label for the green night product appears
under some of the blue day product and vice versa.
Consumers using the affected product may not be
aware of the warnings regarding an antihistamine in the
product that could cause drowsiness.

26. Problems associated with
labeling
1. CONTAINER CONTROL
•One common reason for misapplied labels is a lack of container
control.
•Most dispensing heads will dispense labels with a high degree
of repeatability. If the product is not under control, label
placement will vary.
•For example, placing a front and back label on an oval bottle
can be a challenge. The long axis of the container must be
perfectly parallel with flow.
•When the labeler is set up, the bottle is straight. But, during
production, it may turn slightly. This may not be noticeable
without careful observation and will result in one label closer to
the leading edge of the container and the other closer to the
trailing edge.

27. 2. SKEW
•When the axes of the label and product are not parallel to
each other, it is called "skew." It is especially noticeable on
round bottles with full wrap labels where the label ends will
not match up.
•Skew can occur when the product or the labeling head are
out of plumb. When relating to machine set-up, it can be a
permanent problem. Or, it may be an intermittent problem
related to product movement or machine looseness.
•You should verify that the labeling machine is sufficiently
rigid. Some low-cost labelers are made of lighter gauge
materials, which are prone to vibration and misalignment.
Bracing the machine may steady the head and resolve the
problem.

28. 3. WRINKLES
•Wrinkled labels can result from several causes.
Perhaps the most common occurs when the label is
wiped onto the product when the label dispensing
and product speeds are not exactly synchronized. If
the product is moving more slowly, the label will
wrinkle as it tries to push the product.
•In some cases, you may have to consider a
different kind of a label applicator. For example, a
vacuum grid, roll-on applicator will pre-dispense
the label onto a plate where it is held in place by
vacuum.
•When the product passes, it makes contact with
the end of the label and pulls it from the grid. A
roller or brush wipes the label down as it is pulled.

29. 4. TAMP PAD PROBLEMS
•Tamp applicators consisting of a pad (usually rubber) mounted on
an air cylinder are popular because they work well in many
applications. But when the vacuum holding the label on the pad is
insufficient, the label will slip or even fall off. Venturi vacuum
generators will often accumulate dirt inside. Opening it and
cleaning may resolve the problem.
•Leaky or pinched vacuum hoses can cause similar problems.
•When the tamp-pad wears it may do so unevenly. If the pad is
not absolutely flat, air will leak between the label and the vacuum
holes. When this happens, the vacuum may not hold the label in
position.
•Set up of tamp applicators seems counter-intuitive. Logic dictates
that the pad should go slightly above the labeler peeler plate.
Logical, perhaps, but incorrect.

30. 5. SENSOR PROBLEMS
•Roll-fed labelers generally use a photoelectric sensor to
control where the label stops for dispensing. This sensor must
be properly set to stop the label in the correct position.
•Be sure to set the sensor to the machine manufacturer's
specifications. And, be sure the label and the sensor are
compatible.
•In most cases, the sensor will sense either the gap between
the labels or registration marks. If the sensor cannot detect
this, it will not work properly.
•The linear position of the label on the product is usually
determined by the position of the trigger sensor relative to
the labeling head.
•Setting this position correctly can be tricky and time
consuming. To reduce the set-up, consider mounting multiple
trigger sensors.

31. RegulatoryRegulatory
Requirements forRequirements for
LabelingLabeling

32. Labeling & Packing of drug as per D&C
Act 1940
Legal requirements for labeling of drugs are as follows
•Name of drug (official name, trade name)
•Name of manufacturer & his address along with license no. &
batch no.
•Potency, standard, grade, dose etc expressed as ML, grains,
units etc.
•Net contents by volume/weight/number
•Manufacturing & expiry dates (schedule P & C drugs only)
•Precautions for handling, storage, sale or usage etc.
•Special instructions may be there such as for veterinary use,
physician sample etc.
•Special labeling for, “drug for export”, “dispensed drug”.

33. For schedule G drugs
• “Caution: It is dangerous to take this preparation except under
the medical supervision”.
For schedule H drugs
• Warning: To be sold by retail on the prescription of a registered
medical practitioner only”.
• Symbol Rx prominently on left hand top corner of the label.
• Symbol NRx prominently on left hand top corner for narcotic &
psychotropic substances.

34. Schedule X drugs
• “schedule X drug Warning: To be sold on prescription of RMP
only.
• Symbol XRx in red on left hand top corner.
Ophthalmic solution/suspension/ointment
• Use within one month after opening the container.
• FOR OPTHALMIC USE ONLY
• NOT FOR INJECTION
• Name & concentration of
preservatives if used.
• Special instructions regarding storage
wherever applicable.
• Warning: If irritation persist or increases, discontinue the use &
consult the physician.
• Do not touch the dropper tip or other dispensing tip to any
surface since this may contaminate the solutions.

35. Veterinary drugs
• Not for human use
• For animal treatment only
• Head of any domestic animal
Packing of drugs specified in Sch X
• The drugs specified in sch. X can be marketed
in packing not exceeding
i) 100 unit doses in case of tablet/capsules
ii) 300 ml in case of liquid preparation
iii) 5 ml in case of injection.

36. Labeling of cosmetics
1. On both inner & outer label it should indicate
 Name of the cosmetic
 The name & address of the manufacturer
2. On the outer label, it should indicate the net content of the
package. Such statement need not appear on the label if the net
content does not exceeds 60 ml/30 grams
3. On the inner label, it should indicate, the proper direction of
safe use, warning, caution, or the ‘special direction’ & the names
& contents of ingredients that are poisons or hazardous.
4. The label in addition should indicate
 batch no., only if the content of cosmetics is more than 10 gms or 25 ml, in case of
soap instead of batch no. the month & year of manufacture of soap shall be given
on the label.
 Mfg lic no. Preceded by letter M.
5. If the package or container of the cosmetic has only one label, it
should contain all the information required to be shown on both
inner & outer label.

38. Labeling of hair dyes
• Hair dyes containing coal tar color should label (inner
& outer)
• “Caution: This product contains ingredients which
may cause skin irritation in certain cases & so a
preliminary test according to directions should first be
made . The product should not be used for dyeing eye
lashes or eye brows, as such as use may cause
blindeness.

39. Hair Dye Label Sample

40. Labeling of toothpaste containing
fluorides
• Fluoride content in tooth paste shall not be more
than 1000 ppm & the content of fluoride in terms
of ppm shall be mentioned on tube & carton
• Date of expiry shall be mentioned on tube & carton

41. Leaflets
Package Leaflets (PL)/Patient Information Leaflet
(PIL)

42. The content of the leaflet
Identification of product.
Name of product, statement of active ingredients,
pharmaceutical form, pharmaco-therapeutic group, name and
address of authorization holder.
Therapeutic indications.
Information needed for taking the product.
Contra-indications, precautions for use, interactions, special
warnings, including use in pregnancy, elderly, effect on ability
to drive vehicles and details of any excipients which may be
important for the safe and effective use of the product.

43. The content of the leaflet (Cont.)
 Instructions for use.
 Dosage, method and route of administration, frequency of
administration, duration of treatment where limited, action to
be taken in the case of an overdose or lack of dosing and risk
of withdrawal effects where possible.
 Undesirable effects.
 Effects that can occur under normal use of the product and
action to be taken.
 Expiry date.
 Warning against use of the product after the date,
appropriate storage precautions and warning against visible
signs of deterioration.
 Date on which package leaflet was last revised.

44. • The leaflet must be written in clear, understandable terms, be legible
and be in the official language of the member state.
• Inclusion of symbols or pictures is permitted if in compliance with
the SmPC. (Summary of major product characteristics)
• Since this is a user leaflet the language must be understandable to
the lay person.
• At the time the Directive was issued there were a number of tasks
that the Commission had not yet undertaken and items that were to
be introduced:
1 special warnings
2 special needs for self-medication products
3 legibility of text
4 identification and authentication of medicinal products
5 list of excipients which must appear on the labelling.

45. • The above information relates to a package insert
designed for the patient, but in some cases further
information is required for use by the doctor, dentist
or nurse in supplying or administering the product.
• To cover this need a professional user leaflet may be
included provided it is within the scope of the SmPC,
but even if the product is administered by a
professional a patient insert must also be provided.

46. Paper leaflets can be of
Cut sheet
 Usually printed both sides, delivered as blocks of cut sheet and
folded on the cartoning machine.
 The restrictions on block cut papers are also relevant, i.e. they
should be backed and fronted with band bound card.
Reel-fed
 Like reel-fed labels, but with no backing paper. They are both
guillotined and folded on the cartoning machine.
 Claimed to be more secure than all other types of leaflet.
Pre-folded
 Are delivered as bundles (these need to be ‘broad banded’, not
with elastic bands round them) or contained in plastic cartridges
and fed via a hopper system direct to the cartoning machine,

47.  Combined label/leaflet.
 Delivered as a thick pressure sensitive label (either
reel-fed or block cut), containing a fold-out portion
which is the leaflet itself.
 Applied as one would apply a pressure sensitive label.
These have now been around for a number of years. As
far as can be ascertained, at least six patents have been
taken out in this field. Recently there has been more
use of multi-ply construction of these types of label,
often using dissimilar materials with rather specialist
adhesive systems.
 Probably the best known are Fix-a-Form from Denny,
Peel ‘n’ Reseal booklet labels, Multipeel, a peel off
promotional leaflet or sticker, Dri-peel, Incore and the
Double-Dri system.
 Leaflets use high-opacity (80%+EEL) lightweight (40–70
g/m2) coated or uncoated papers.