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Search results for "Codex Alimentarius" in comments (approximate match)
Status:
Possibly Marketed Outside US
Source:
M003
(2022)
Source URL:
First approved in 1985
Source:
NDA207768
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Ethyl maltol, a key food additive, and flavor enhancer is safe and is the most common sweet-associated component in electronic cigarette liquids. Ethyl maltol binds to human serum albumin (HSA) by situating within subdomain IIA (site I) of HSA.
Status:
Possibly Marketed Outside US
Source:
A-TEAM
Source URL:
First approved in 1984
Source:
NU-DERM SUNFADER Skin Lightener with Sunscreen (SPF 15) PABA FREE by OMP, INC.
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Butylated hydroxytoluene, commonly known as BHT, is an organic compound that is used in the food, cosmetic, and pharmaceutical industry as an antioxidant. BHT is a substituted derivative of phenol. BHT helps to prevent the formation of free radicals and oxidation. When used in food products, it delays oxidative rancidity of fats and oils, and prevents loss of activity of oil-soluble vitamins. It may be found in pharmaceutical gels, creams and liquid or gelatin capsules, tablets and other pharmaceutical dosage forms. The ability of oral BHT to lead to cancer is a controversial topic, but most food industries have replaced it with butylated hydroxyanisole (BHA). BHT was first used as an antioxidant food additive in 1954. BHT does have other commercial uses, as in animal feeds and in the manufacture of synthetic rubber and plastics, where it also acts as an antioxidant. The U.S. Food and Drug Administration has deemed that BHT is safe enough when used in limited concentrations. It currently permits its use in concentrations of about 0.01% to 0.02% in most foods. As an emulsion stabilizer in shortening, it may be used in a somewhat higher concentration, 200 parts per million.
Status:
Possibly Marketed Outside US
Source:
EDEX
Source URL:
First approved in 1981
Source:
NDA021212
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Alfadex also known as α-cyclodextrin, is used as an inactive ingredient in order to improve the water solubility of the different drugs, e.g. edex: is a sterile, pyrogen-free powder containing alprostadil in an alfadex inclusion complex. After intravenous infusion of radiolabeled α-cyclodextrin to healthy volunteers, the radiolabeled components were rapidly eliminated within 24-hours, urine accounting for 81-83% of radioactivity and feces for 0.1%. There was no evidence of significant accumulation of radiolabeled α-cyclodextrin in the body even after 7 days of repeated intravenous injection. After intracavernous administration in monkeys, radiolabeled α¬ cyclodextrin was rapidly distributed from the injection site with less than 0.1% of the dose remaining in the penis 1 hour after administration. There was no evidence of tissue retention of radiolabeled α-cyclodextrin in monkeys.
Status:
Possibly Marketed Outside US
Source:
21 CFR 333A
(1980)
Source URL:
First approved in 1980
Source:
21 CFR 333A
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Sorbitan monostearate (Span 60) is a non-ionic surfactant with emulsifying, dispersing, and wetting properties used as a food additive, additive in mixtures for drug use and in skin care products. It is approved for use by FDA in quantities not exceeding the amount reasonably required to accomplish the intended effect. 0.5-5% of Liposorb® S (sorbitan monostearate) is used for oil-in-water emulsions in combination with a high hydrophilic-lipophilic balance emulsifier to produce smooth lotions and creams in skin and hair care, make-up bases, and mild cleaning products. Sorbitan monostearate based organogels and vesicles (niosomes) formulated to enhance the oral bioavailability were characterized for use as a drug delivery vehicle. In combination with other non-ionic surfactants sorbitan monostearate is patented for use in vaccine formulations as a saponin-containing adjuvant for oil-in-water injectable emulsions. It is fatty acid ester of sorbitan (a sorbitol derivative) and stearic acid sometimes called synthetic wax. Has low hydrophilic-lipophilic balance. Non-toxic.
Status:
Possibly Marketed Outside US
Source:
NCT02104596: Phase 4 Interventional Unknown status Knee Osteoarthritis
(2014)
Source URL:
First approved in 1978
Source:
60-Second Fluoride Pina Colada by Patterson Dental Supply Inc
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Xylitol is a naturally occurring alcohol found in most plant material, including many fruits and vegetables. Xylitol is widely used as a sugar substitute and in "sugar-free" chewing gums, mints, and other candies. As a medicine, xylitol is used to prevent middle ear infections (otitis media) in young children, and as a sugar substitute for people with diabetes. Xylitol is added to some chewing gums and other oral care products to prevent tooth decay and dry mouth.
Status:
Possibly Marketed Outside US
Source:
21 CFR 347
(2012)
Source URL:
First approved in 1977
Source:
NDA017563
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Maltol is a naturally occurring organic compound isolated from pine needles, larch bark, the destructive distillates of various organic materials and the alkaline hydrolysis products of streptomycin. Because of caramel-butterscotch odor, and suggestive of fruity-strawberry aroma in dilute solutions, maltol is used as a food additive mainly in confectionary and bakery products. Maltol is considered safe by FDA according to existing data and granted GRAS status. Maltol chelates metal ions such as Fe3+, Al3+, and is reported to increase uptake of aluminum and iron in the body. Maltol was reported to have a neuroprotective effect on retinal ganglion cells under oxidative stress, and hepatoprotective effect on alcohol-induced liver oxidative injury.
Status:
Possibly Marketed Outside US
Source:
M
(1974)
Source URL:
First approved in 1974
Class (Stereo):
CHEMICAL (ACHIRAL)
Propane, an alkane that at standard temperature and pressure is a gas. It has a role as a food propellant. Propane in combination with butane was used for recreational inhalation in adolescents. That use caused to death. The compounds found in tissues and biological fluids were perfectly compatible with those contained in the containers used for the inhalation. The mechanisms of death were assessed in a combination of the direct toxicity of the compound and oxygen replacement.
Status:
Possibly Marketed Outside US
Source:
Vaginne Intimate Hygiene Wash by WOYA BIO-TECHNOLOGY CO.,LTD.
(2022)
Source URL:
First approved in 1973
Source:
ANDA083231
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Sorbitan laurate (Span 20) is a mixture of the partial esters of sorbitol and its mono- and dianhydrides with edible lauric acid. It is an excipient. Sorbitan laurate is a non-ionic surfactant that is widely used as an emulsifier and stabilizer in pharmaceutical formulations, food and cosmetic industries. As a food additive, it is designated with the E number E493. Span 20 finds application in topical preparations. It is soluble in many fatty compositions and solvents and dispersible in water, dilute acids and alkalis. Recommended topical usage levels of 0.5-5%.
Status:
Possibly Marketed Outside US
Source:
21 CFR 334
(2010)
Source URL:
First approved in 1972
Source:
ANDA061621
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Sorbitan monooleate (Span 80) is a partial oleate ester of sorbitol and its mono- and dianhydrides. Sorbitan Monooleate is a nonionic emulsifier and surfactant and used in cosmetics and foods. It is a food additive with the E number E495. Span 80 was suitable as surfactant in the preparation of Poly(divinylbenzene) emulsion-derived (PolyHIPE) solid foam. Anionic nanoparticles based on Span 80 as low-cost, simple and efficient non-viral gene-transfection systems. Sorbitan monooleate is approved by FDA to be used as an emulsifier in polymer dispersions that are used in the clarification of cane or beet sugar juice or liquor in an amount not to exceed 7.5 percent by weight in the final polymer dispersion. The additive is used in an amount not to exceed 0.70 part per million in sugar juice and 1.4 parts per million in sugar liquor.
Status:
Possibly Marketed Outside US
Source:
Ovaplant-L by Western Chemical Inc.
(2023)
Source URL:
First approved in 1972
Source:
NDA204803
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)