[01-PRELIMS-ANALYSIS-LAB] INSPECTION OF LABEL AND BOX

Primary packaging materials

Packaging Materials:

• Direct contact with the product.

• Affect stability.

• Bottles, caps, or closures, aluminum foil or tubes.

Secondary packaging materials

Packaging Materials:

• Not in direct contact with the product.

• Accessory to the primary packaging.

• Labels, individuals, boxes, inserts, corrugated boxes.

Labels

The display of written, printed or graphic matter on the immediate container.

Labeling Materials

All labels and other written, printed or graphic matter upon an immediate container of a preparation or upon, or in, any package or wrapper in which it is enclosed, except any outer shipping container.

Principal Display Panel

This is the front of the package and is easily seen by the consumer at the time of purchase.

40%

What is the percentage of the principal display panel?

• Name of the product (generic + brand name)

• Dosage form and strength

• Pharmacologic category

• Rx symbol if prescription drug

• Company logo, name and address

• Net content

What should be seen in the principal display panel?

Company logo, name and address

Out of the information that is included in the principal display panel, what info is optional to include?

1. Formulation

2. Indication

3. Contraindications, Precautions, Warnings

4. Direction of Use

5. Batch/Lot Number

6. Manufacturing and Expiration Date

7. Storage Conditions

The labels should include the following: