Medical Product Label

Preferred Label : Medical Product Label;

NCIt synonyms : Drug Label; Pharmaceutical Product Label; package insert; patient package leaflet;

NCIt related terms : label; package insert, patient package leaflet; Product Label;

NCIt definition : Any display of a written, printed, or graphic matter upon the immediate container of any substance or device to identify something and to indicate the nature, ownership, contents and other characteristic particulars of the object. FDA and the Supreme Court have stated that label is to be interpreted liberally, and includes not only that which accompanies an article but also that which spiritually accompanies an article as well as supplements. Drug label must include: trademark and category of product, description of product chemical and physical characteristics, clinical pharmacology, pharmacokinetics, data on absorption, distribution, metabolism and excretion, special populations, clinical studies, efficacy and safety data, indications, contraindications, adverse events warnings and precautions including lab tests; potential drug interactions, carcinogens statement, pregnancy category.;

Alternative definition : CDISC-GLOSS: Description of a drug product/ device that includes: the indication, who should use it, adverse events, instructions for use, and safety information. NOTE: Labels must be approved by regulatory authorities. [FDA; SPL];

Details

Origin ID

C41203;

UMLS CUI

C1705425;

Automatic exact mappings (from CISMeF team)
- Drug Labeling [DeCS]
- Labeler - product (occupation) [SNOMED CT concept]
- Labelling [HPMULTI term]
- Off label use [MedDRA Preferred Term]
- Off-Label use [MeSH Descriptor]
- Product Labeling [DeCS]
- label [IUPAC Term]
- labeling [Artificial nutrition thesaurus concept]
- labeling [Blood Transfusion thesaurus concept]
- labeling [NCCMERP Class]
- labelling [IUPAC Term]
- obsolete_label role [OBI concept]
Currated CISMeF NLP mapping
- drug labeling [MeSH Descriptor]
- drug labeling [MeSH concept]
- package insert [NCCMERP Descriptor]
- package inserts [MeSH concept]
- product labeling [MeSH Descriptor]
- product labeling [MeSH concept]
Semantic type(s)
- Intellectual Product [UMLS semantic type]
concept_is_in_subset
- CDISC Glossary Terminology [NCIt concept]
- Clinical Data Interchange Standards Consortium Terminology [NCIt concept]

Keyword's position in hierarchy(ies) :

Main resources

You can consult :

recommendations
documents concerning education
documents for patients