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Search results for trolamine in Display Name (approximate match)
There is no information about properties of trolamine salicylate monoester (also known as 2-(Bis(2-hydroxyethyl)amino)ethyl salicylate), except that this chemical substance is an ingredient of sunscreen.
Status:
US Previously Marketed
Source:
21 CFR 310.545(a)(18)(iv) skin protectant:fever blister/cold sore trolamine
Source URL:
First approved in 1952
Source:
NDA007936
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Trolamine, an organic compound, is the salt formed between triethanolamine and salicylic acid. It is widely used as a topical analgesic. 10% trolamine salicylate medical products sold over-the-counter such as are creams for temporarily relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, lumbago, neuralgia, strains, bruises, and sprains. The FDA approved in 1958 otic solution drops containing triethanolamine polypeptide used in the ear to break down and loosen earwax was discontinued. Trolamine can enhance skin healing by recruiting macrophages and modifying the concentrations of various immunomodulators. Trolamine (Biafine; Genmedix Ltd, France) is commonly prescribed at the beginning of radiotherapy for preventing acute radiation-induced skin toxicity in China. Biafine has been studied in radiodermatitis and Phase 2 clinical trial has been initiated in 2016 by Sun Yat-sen University to establish the efficacy of trolamine (Biafine) for the management of radiation dermatitis in patients with nasopharyngeal carcinoma receiving IMRT.
Status:
Possibly Marketed Outside US
Source:
505G(a)(3)
(2018)
Source URL:
First approved in 2018
Source:
505G(a)(3)
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)