Adhesive Bandage
»Adhesive Bandage consists of a compress of four layers of Type I Absorbent Gauze,or other suitable material,affixed to a film or fabric coated with a pressure-sensitive adhesive substance.It is sterile.The compress may contain a suitable antimicrobial agent and may contain one or more suitable colors.The adhesive surface is protected by a suitable removable covering.
Packaging and storage— Package Adhesive Bandage that does not exceed 15cm (6inches)in width individually in such manner that sterility is maintained until the individual package is opened.Package individual packages in a second protective container.
Labeling— The label of the second protective container bears a statement that the contents may not be sterile if the individual package has been damaged or previously opened,and it bears the names of any added antimicrobial agents.Each individual package is labeled to indicate the dimensions of the compress and the name of the manufacturer,packer,or distributor,and each protective container indicates also the address of the manufacturer,packer,or distributor.
Sterility á71ñ: meets the requirements.
Auxiliary Information— Staff Liaison:Radhakrishna S Tirumalai,Scientist
Expert Committee:(GTB)General Toxicology and Biocompatibility
USP28–NF23Page 218
Phone Number:1-301-816-8339