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.

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.

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.

Eye drops Code

Adrenaline, neutral ADN

Amethocaine AME

Betamethasone BET

Chloramphenicol CPL

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.

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

Labeling Requirements For Eye Drop And Eye Ointment Container At The Time Of Dispensing:

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 with self

container tip

glass bottles with separate droppers

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 .

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 .

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.

fig: Single dose blow fill seal packaging

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 .