U.S. Department of Health & Human Services Divider Arrow National Institutes of Health Divider Arrow NCATS

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Showing 31 - 40 of 62 results

Status:
US Approved OTC
Source:
21 CFR 349.12(d)(4) ophthalmic:demulcents polysorbate 80
Source URL:
First approved in 1949
Source:
Olothorb by Merck Sharp & Dohme
Source URL:

Class:
POLYMER


Polysorbate 80 is a nonionic surfactant and emulsifier often used in foods and cosmetics. Polysorbate 80 is an excipient that is used to stabilize aqueous formulations of medications for parenteral administration, and used as an emulsifier in the manufacture of the popular antiarrhythmic amiodarone. Polysorbate 80 is also used as an excipient in some European and Canadian influenza vaccines. Influenza vaccines contain 25 μg of polysorbate 80 per dose. Polysorbate 80 is also used in the culture of Mycobacterium tuberculosis in Middlebrook 7H9 broth. It is also used as an emulsifier in the estrogen-regulating drug Estrasorb. In Europe and America, people eat about 100 mg of polysorbate 80 in foods per day on average. Polysorbate 80 has not been found to be carcinogenic. Rats fed with diets containing up to 5% polysorbate 80 by volume for 12 weeks showed no toxic effects.
Status:
US Previously Marketed
Source:
21 CFR 310.545(a)(12)(iii) laxative:stool softener poloxamer 188
Source URL:

Class:
POLYMER

Status:
US Previously Marketed
Source:
21 CFR 310.527(a) hair loss prevention polysorbate 20
Source URL:
First approved in 1978
Source:
60-Second Fluoride Pina Colada by Patterson Dental Supply Inc
Source URL:

Class:
POLYMER

Status:
US Previously Marketed
Source:
Triton by Winthrop
(1953)
Source URL:
First approved in 1953
Source:
Triton by Winthrop
Source URL:

Class:
POLYMER


Tyloxapol is a nonionic liquid polymer of the alkyl aryl polyether alcohol type that is used as a surfactant to aid liquefaction and removal of mucopurulent (containing mucus and pus) bronchopulmonary secretions. Tyloxapol is also used as a detergent, dispersing agent, encapsulating agent and a hydroxy radical scavenger. Tyloxapol has been used as a mucolytic agent for over 50 years and has proven to be well tolerated during this time. Tyloxapol influences the respiratory system by the following four different action mechanisms: secretolytic action, reduction of surface tension, dissolution of coatings and down-regulation of inflammation. Several studies have shown that small quantities of Tyloxapol applied as an aerosol liquefy sputum. The viscosity of sputum is reduced by 10% to 20% according to rotational viscosimetry measurements. Tyloxapol also penetrates the mucous wall and dissolves viscous and dried secretions, thus enabling increased ciliary activity in the respiratory tract. Although the mechanism of Tyloxapol has been well described, and there is a long-standing basis for its clinical usefulness, there are almost no randomized, double-blind, placebo-controlled trials available that demonstrate the superiority of Tyloxapol vs. saline. Side-effects in the form of hypersensitivity reactions have only occurred very rarely.
Status:
US Previously Marketed
Source:
21 CFR 310.545(a)(28)(ii) vaginal contraceptive octoxynol 9
Source URL:

Class:
POLYMER