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Search results for trolamine in Reference Text / Citation (approximate match)
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:
US Previously Marketed
Source:
GANTRISIN by ROCHE
(1961)
Source URL:
First approved in 1949
Source:
GANTRISIN by ROCHE
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Diethanolamine (DEA) is an amino alcohol commonly used in the preparation of soaps and surfactants, agricultural chemicals and in textile processing. DEA and DEA-Derivatives are used in other products besides cosmetics and personal care products. For example, DEA and DEA-derivatives have been approved for several food-related applications, primarily food packaging.
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)
Status:
Possibly Marketed Outside US
Source:
21 CFR 333A
(2006)
Source URL:
First approved in 2006
Source:
21 CFR 333A
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
Possibly Marketed Outside US
Source:
NDA022032
(2008)
Source URL:
First approved in 1980
Source:
NADA113232
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Monoethanolamine is both a primary amine and a primary alcohol. It is an olamine derivative. Monoethanolamine occurs in every cell in the human body as the head group of Phosphatidylethanolamine. Monoethanolamine is a component of glycosylphosphatidylinositol-anchored proteins, which are essential for viability. Other sources of monoethanolamine or phosphoethanolamine in the human body are the degradation of sphingosine phosphate by sphingosine phosphate lyase and the degradation of the endocannabinoid anandamide by the fatty acid amine hydrolase. Monoethanolamine stimulates the rapid growth of mammalian cells in culture. Monoethanolamine has a cardioprotective role against ischemia/reperfusion injury via activation of the transcription factor STAT-3. Monoethanolamine is a chemical intermediate in the manufacture of cosmetics, surface-active agents, emulsifiers, pharmaceuticals, and plasticizing agents.