Carton labels

This section encompasses the initial draft labeling submitted with the BLA and the final printed labeling that is submitted just prior to licensure. Labeling includes the immediate container label, carton label, insert, and user instructions. The container and package labels should permit accurate identification of the contents, whereas the package insert should summarize the essential information required for the product s safe and effective use. These data should be accurate, balanced, informative and nonpromotional. When possible, the information should be based on data obtained from the product s use in humans. 

Envelope and presentation tablets. Single foil-sealed tablets are attached to an envelope card labelled with full instructions for use and precautions. Several envelope cards are packed in a single outer carton labelled with full instructions for use and precautions. 

The term label can mean the label on the immediate container, the carton label, the outer label or the label on the case or pallet. Each label has a different function. A leaflet, enclosed within the carton, can be a patient leaflet or a professional user leaflet, or in some cases a summary of product characteristics (SPC). 

The doctor who has prescribed the medicine does not generally handle it personally. He or she does, however, require reliable information on the name, presentation and strength, indications, contra-indications, dosage instructions, precautions, interactions, side-effects and pack sizes which must be absolutely consistent with the details on the immediate label, carton label and any package leaflets enclosed. Since he or she does not handle the product, some other mechanism must be found to provide him or her with this information separately from the product. This is probably the SPC or summary of major product characteristics (SmPC, see below) data sheet. 

Thus, the patient has the label on the primary container and package insert, the wholesaler has the carton and pallet labels, and the pharmacist has the immediate container label, the carton label, package insert and possibly the SPC. The doctor looks at the SPC or equivalent document, probably in a compilation of such documents, such as the data sheet compendium in the UK. 

These thermoplastic pigments found application in a much wider range of finished products. New, large-volume applications included coated paper for labels and point of purchase signage, gravure for soap box cartons and bright textiles for fashion, and safety applications. 

Amino resins are used by the paper industry in large volume for a variety of apphcations. The resins are divided into two classes according to the mode of appHcation. Resins added to the fiber slurry before the sheet is formed are called wet-end additives and are used to improve wet and dry strength and stiffness. Resins appHed to the surface of formed paper or board, almost invariably together with other additives, are used to improve the water resistance of coatings, the sag resistance in ceiling tiles, and the scuff resistance in cartons and labels. 

If financially feasible, suggest the use of commerdally available drug organizers. If the patient cannot afford drug organizers, egg cartons or a muffin tin can be labeled and used as drug organize s. 

Lined carton systems, bag in box, etc., plus a range of packaging components Labels... 

Use tape or a permanent marker to label the outside of nine wells of your egg carton with the nine different half-cells. Each well should correspond to one of the eight different metal/metal ion pairs Mg/Mg ", Cu/Cu, A1/AP+, Ni/Ni h Zn/Zn2+, Sn/Sn2+, Fe/Fe, and Ag/Ag. Label the ninth well H /H2. 

Pour 5 mL of each metal salt solution into the appropriate well of the egg carton. Pour 5 mL of the nitric acid into the well labelled H+/H2. 

Correctly labeled product in the wrong carton or package. Strength of product incorrectly labeled Microbial contamination of nonsterile products. Drug product marketed without an approved new or generic... 

Specifications are normally written by QC personnel. They detail the exact qualitative and quantitative requirements to which individual raw materials or product must conform. For example, specifications for chemical raw materials will set strict criteria relating to the percentage active ingredients present, permitted levels of named contaminants, etc. Specifications for packing materials will, for example, lay down exact dimensions of product packaging cartons specifications for product labels will detail label dimensions and exact details of label text, etc. Specifications for all raw materials are sent to raw material suppliers and, upon their delivery, QC personnel will ensure that these raw materials meet their specifications before being released to production (the raw materials are held in quarantine prior to their approval). Final product specifications will also be prepared. As most products are manufactured to conform with pharmacopoeial requirements, many of the specifications set for raw materials/finished product are simply transcribed from the appropriate pharmacopoeia. 

Offset lithography is the most common process used for printing on paper. It is used for folding carton stock and for can and bottle labels. Most lithographic presses are sheet fed, although there are some web-fed presses. A particular application of offset lithography is the printing of flat metal sheets that are then... 

Labeling Correctly labeled product in incorrect carton or package FIGURE 5 Top 10 reasons for drug recalls in fiscal year 2005. (Source FDA.)... 

Package The container closure system and labeling, associated components (e.g., dosing cups, droppers, spoons), and external packaging (e.g., cartons, shrink wrap). 

This section covers package decoration formats rather than the detail of their printing. Packaging that is delivered pre-printed, such as cans and drinks cartons, is covered in Sections 9.6-9.8. Decoration formats include labels that are stuck on to packages and heat-shrink plastic sleeves, which may be applied through a labelling technology or as a pre-made sleeve and heat-shrunk into place. 

Operational tests Check weigher Bottom coder Security sealer Labeller Cartoner Shrink bundler Case packer Case sealer... 

Paper and board packaging is used mainly for secondary and tertiary packaging (e.g., labels, leaflets, cartons, and cases). Various dressings, pouches, and medical devices have paper as a contact material. 

Plastic and elastomer packaging is used for bottles, jars, ampules, closures, plugs, films, sheets, labels, shrink sleeves, wads, cartons, and tubings. The barrier properties of plastics vary widely. Some detailed knowledge is required on the barrier of plastics to moisture, and to vapors and gases in order to make an optimum choice for a given product and application. 

Labeling or identifying the contents of the primary container Adding leaflet(s) as required for all pharmaceuticals Using carton/display outer application (i.e., secondary packaging) if necessary... 

No container (or film), no fill No container, no ullage filler, no closure No container, no label No container, no carton No leaflet, no carton... 

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