The document discusses labeling requirements and packaging for ophthalmic preparations. It states that labels must include the name of the drug, dosage, manufacturer, and expiration date. Labels can be printed directly on containers or applied separately. Eye drop packaging comes in glass bottles with droppers or plastic bottles with integrated droppers. Plastic is now more common. Packaging must be sterile and can be single-dose without preservatives or multi-dose which requires preservatives to maintain sterility between uses.

1.  Labelling : The term labelling designates all labels and other written, printed
or graphic matter up on or in any package or wrapper in which it is enclosed.
 The label states the name of the preparation, percentage content of drug of a
liquid preparation, the amount of active ingredient of a dry preparation, the
volume of liquid to be added to prepare an injection or suspension from a dry
preparation, the route of administration, a statement of storage condition and
expiry date. Also label must indicate the name of manufacturer or distributors
and carry an identifying lot number.

2. Types of labelling
 Various materials are used for labelling such as paper, foil and fabric. it is also possible to
print directly on a bottle or other containers by means of silk screen, offset or hot transfer
process.
Method of applying a label
 Hot melts
 Semi automatic labelling
 Fully automatic labelling .
Standard Requiremnt For Labelling
 All labels must be type written or computer generated. The details, which must appear on
the label of a dispensed medicine are-
 · The name of the preparation.
 · The quality.
 · Instructions for the patient.
 · The date of dispensing.
 · Keep out of reach of children.

3. Additional Labellng Requirement:
 storage
 temperature
 humidity
 light
 Instructions to the patient how to use ,
 Batch number
 Expiary date
 INSTRUCTIONS
 Tip of the dropper should not be touched with fingers
 If there is any leakage it should not be used
 After instilling the drops into the eye,if any irritation is produced the patient
must be refer back to the physician
Labelling Of Ophthalmic Preparation:
 The label should state the name and concentration of any antimicrobial
preservative or other substance added to the preparation. For multidose
containers the label should state the period after opening the containers after
which the contents should not be used.

4. Codes For Eye Drops In Single Dose Containers:
The following codes are approved for use on single unit dose of eye drops
where the individual may be too small bear cell of the appropriate labeling
information.
Eye drops Code
Adrenaline, neutral ADN
Amethocaine AME
Betamethasone BET
Chloramphenicol CPL

5. Labeling Requirements For Eye Drop And Eye
Ointment Container At The Time Of
Dispensing:
Requirement Include on the label
State route of administration For external use only
Fully identify the product The name and concentration of active
ingredient(s)
Statement on preservation Confirm presence or absence of preservative
Direction for use Ex: Add one drop to each eye morning and
evening.
Statement on in use expiry date Day, month, year
Storage requirements ‘Store in cool place’ or ‘Protect from light’
Identify patient Patient’s name

7. Packaging of eye drops
 Ophthalmic liquids can be packaged in sterile
glass bottles with separate droppers or in plastic
bottles with self-contained dropper tips
Plastic bottle glass bottles with
with self
container tip separate droppers

8.  Glass bottle packaging
 Dropper bottle for eye drops is a hexagonal shaped amber
glass container fluted on three sides . they are fitted with a
cap , rubber teat and dropper as the closure. The bottles are
used at a capacity of 10 ml or 20 ml . In only a very few
instances are glass containers are used , because of stability
limitations . Type 1 glass vials with appropriate stoppers are
used for ophthalmic products .
Fig : 10 ml amber glass dropper bottle .

9.  Plastic packaging
 Currently all most all commercially available ophthalmic
products are packaged in plastic containers . Advantages of
plastic containers are ease of use , little breakage , less
spillage . this led to universal acceptance of plastic containers.
Plastic packaging components consists of bottle fitment and
closure . It has multi-component single-drop dispenser. Eye
drops must be sterile zed after filling into the containers and
sealing , by autoclaving at a temperature of 90-100 C for 30
mins , or alternatively they may be pre sterilized and filled
aseptically into previously sterilised containers . The
containers are usually fitted with droppers attached to the
closuers .

10.  There are two types of dose preparations in plastic packaging
 Single dose preparations
 Multiple dose preparations
Single dose preparations
 The ideal type of packaging for eye drops is a disposable one shot
container which eliminates the need for any preservative and
reduces the risk of infecting the eye during applications almost to
zero
 Single dose packs are available in which the solutions can be
sterilised by autoclaving in air ballasted autoclaves these solutions
can therefore be formulated without a preservative . Single-use b-
f-s vials, when filled under sterile conditions, have the additional
advantage of enabling the product to be formulated without
preservatives; most products in multi-use containers need
preservatives to counteract the ingress of microorganisms after
each use.

11. fig: Single dose blow fill seal packaging

12.  Multiple dose preparations
 multiple dose preparations must contain an antimicrobial
preservative to prevent proliferation of contaminants during
use and to support the maintenance of sterility .
 Examples of preservatives are phenyl mercuric nitrate or
acetate , chlorhexidine acetate or benzalkonium chloride .