Introduction
According to the United States Pharmacopeia (USP), drug labelling otherwise known as prescription labelling is a written, printed or graphic matter upon any drugs or any of its container, or accompanying such a drug. Drug labels seek to identify drug contents and to state specific instructions or warnings for administration, storage and disposal.
Types of Pharmaceutical Label
- Manufacturer label
- Dispensing label
Manufacturer Label
According to FDA, Manufacturer label is label which contain drug information for the use of medical practitioners, pharmacists, or nurses supplied by the manufacturer, packer, or distributor of the drug.
Legal Requirements of a Manufacturer Label
- The name of preparation
- Strength and dosage form.
- Quantity.
- Instructions for the use.
- Precautions & warnings.
- Registration number.
- Batch number.
- Manufacturing & Expiry date.
- Price
- The name and address of pharmaceutical industry
Dispensing Label
The details which must appear on the label of a dispensed medicine are:
- The name of the preparation, strength
- The quantity
- Instructions for use
- Precautions relating to the use of the product
- The patient’s name
- The date of dispensing
- The name and address of the pharmacy
- Keep out of the reach and sight of children
- ‘For external use only’ for certain formulations, such as semi-solids
Additional labelling requirements
- Warning or advisory label
- A batch number should be indicated
- An expiry date should be indicated
- Storage conditions
Examples
- Simple Ointment BP is used as an emollient, or for making other ointments. It is packed in ointment jar or collapsible tube. A ‘store in a cool place’ label is necessary since the product can be melted by high temperatures. An expiry date of 4 weeks is appropriate.
- Aqueous Cream BP is an emollient and can be used as a base for drugs. It is packed in an ointment jar or collapsible tube. The preparation should be stored in a cool place, but not allowed to freeze. A shelf life of 2 – 3 weeks is appropriate because of instability.
- Dithranol Paste BP is used to treat psoriasis. There are two strengths of Dithranol paste, the ‘weak’ is 0.1% and the ‘strong’ is 1%. A range of intermediate strengths is prescribed by dermatologists. It is packed in a 120 g brown ointment jar, with a circle of greaseproof paper and a tight-fitting closure, or a collapsible tube. The label should include the words ‘To be spread thinly’. The product should be kept in a cool place, protected from light. An expiry date of 2 weeks is appropriate because of chemical instability.
References
- Drug Labelling. Wikipedia. Accessed August 9, 2021
- Labeling Information | Drug Products. FDA. Accessed August 9, 2021
- Kiran Hameed. Pharmaceutical labelling. SlideShare. Accessed August 9, 2021
- Pharmaceutical Labeling: Understanding Requirements & Guidelines. CTM Labelling Systems. Accessed August 9, 2021