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Search results for "PART 172 -- FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION" in comments (approximate match)
Status:
Possibly Marketed Outside US
Source:
21 CFR 333D
(2012)
Source URL:
First approved in 2000
Source:
21 CFR 352
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Sodium dehydroacetate, a water-soluble antiseptic, is a food and feed additive with antimicrobial effects. Recently published studies have shown that sodium dehydroacetate in patients with leg ulcers could cause allergic contact dermatitis.
Status:
Possibly Marketed Outside US
Source:
21 CFR 343
(2006)
Source URL:
First approved in 1991
Source:
ANDA065154
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Monostearyl fumarate (sodium stearyl fumarate) is a lubricant for use in tablet formulation, it can be used as a taste-masking agent in orally disintegrating tablets. It is a conditioning and stabilizing agent.
Status:
Possibly Marketed Outside US
Source:
Rejuvesol
Source URL:
First approved in 1987
Source:
21 CFR 349
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
CTI-01 (ethyl pyruvate) is an investigational anti-inflammatory agent for the treatment of critical inflammatory conditions. CTI-01 was developed by Critical Therapeutics as a stable prodrug of pyruvate, a potent antioxidant, and a free radical scavenger. The drug showed an anti-inflammatory and tissue protection activity in animal models of pancreatitis, ischemia-reperfusion injury, sepsis, renal injury, and endotoxemia. CTI-01 was investigated in phase 2 clinical trials on patients undergoing cardiac surgery with cardiopulmonary bypass, but despite positive results in animal models, administration of EP does not appear to confer any benefit to cardiac surgical patients undergoing cardiopulmonary bypass. Besides clinical applications, ethyl pyruvate is long used as an additive to pharmaceutical preparations and foods, including candy, beverages, and baked goods. It is generally recognized as safe by the FDA.
Status:
Possibly Marketed Outside US
First approved in 1982
Source:
NDA018467
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Readily soluble in water, SnF2 is hydrolysed. At low concentration, it forms species such as SnOH+, Sn(OH)2 and Sn(OH)3−. At higher concentrations, predominantly polynuclear species are formed, including Sn2(OH)22+ and Sn3(OH)42+. Aqueous solutions readily oxidise to form insoluble precipitates of SnIV, which are ineffective as a dental prophylactic. Tin(II) fluoride, commonly referred to commercially (with tin(II) in Latin) as stannous fluoride, is a chemical compound with the formula SnF2. It is a colorless solid used as an ingredient in toothpastes that are typically more expensive than those that use sodium fluoride. Stannous fluoride has both bactericidal and bacteriostatic properties, which fight plaque and treat/prevent gingivitis. The stannous fluoride also deposits a protective mineral barrier over exposed dentinal tubules to help prevent sensitivity pain from triggers such as hot or cold liquids and foods. Stannous fluoride is used under the trade name "Fluoristan" in the original formulation of the toothpaste Crest, though it was later replaced with sodium monofluorophosphate, or "Fluoristat". It is the active ingredient in Crest Pro Health brand toothpaste. Crest Pro Health issues a warning on the tube that stannous fluoride may cause staining, which can be avoided by proper brushing, and that its particular formulation is resistant to staining. Any stannous fluoride staining that occurs due to improper brushing is not permanent. Stannous fluoride is also used in Oral-B Pro-Expert. Stannous fluoride is also readily available in over-the-counter rinses.
Status:
Possibly Marketed Outside US
First approved in 1978
Source:
NDA020963
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Benzododecinium, a quaternary ammonium compound, is an antiseptic agent and disinfectant. Benzododecinium is used as preservative in different pharmaceutical formulations. Thus, the dispenser of Timoptol-LA, used for the treatment of patients with ocular hypertension, contains benzododecinium bromide as a preservative. It is used as preservative and the corneal permeability enhancer in formulation. Benzododecinium is effective against gram-positive microbes.
Status:
Possibly Marketed Outside US
Source:
NCT02168478: Phase 4 Interventional Completed Allergy
(2014)
Source URL:
First approved in 1952
Source:
NDA007936
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Sodium Lauryl Sulfate (SLS) is an anionic surfactant naturally derived from coconut and/or palm kernel oil. It usually consists of a mixture of sodium alkyl sulfates, mainly the lauryl. It is a widely used and inexpensive chemical found in many mainstream personal hygiene products such as shampoos, toothpastes, soaps, detergents and body wash. SLS is a detergent and surfactant, which essentially means that it breaks surface tension and separates molecules in order to allow better interaction between the product and your hair. It is also widely used as a skin irritant when testing products used to heal skin conditions. It was found that SLS represented a potential candidate for the use as a topical microbicide to prevent the sexual transmission of HIV-1, herpes, human papillomavirus and possibly other sexually transmitted pathogens. The mechanism of action of SLS involves the solubilization of the viral envelope and/or the denaturation of envelope and/or capsid proteins.
Status:
Possibly Marketed Outside US
Source:
NCT00442962: Phase 4 Interventional Completed HIV Infections
(2007)
Source URL:
First approved in 1946
Source:
NDA006035
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Maleic acid monosodium salt. Used in water soluble polymers preparation.
Status:
US Approved OTC
Source:
21 CFR 341.14(b)(2) cough/cold:antitussive menthol
Source URL:
First marketed in 1921
Class:
MIXTURE
Targets:
Conditions:
Menthyl lactate is derived from menthol, a compound that comes from peppermint oil, or is made synthetically. Menthol has a natural cooling effect, which makes it useful as a topical analgesic to treat skin irritation, pain, itching or sunburn. Despite its cooling benefits, menthol can be a skin irritant. Like menthol, menthyl lactate is cooling, but it causes less skin irritation than menthol. Menthyl lactate also has a refreshing, minty taste. For this reason, some manufacturers use it as a flavoring ingredient. The compound is recommended for use as a flavor in concentrations of 0.005% to 0.2% and in cosmetic and other external products in concentrations ranging from 0.2% to 2.0%. Menthyl lactate is a known compound available e.g. from Haarmann & Reimer GmbH (Germany) under the name FRESCOLAT, Type ML.
Status:
Other
Class:
MIXTURE
Status:
US Approved Allergenic Extract
(1994)
Source:
BLA103738
(1994)
Source URL:
First approved in 1994
Source:
BLA103738
Source URL:
Class:
MIXTURE
Targets:
Clove oil is a natural product, derived from the Eugenia caryophyllata tree. Clove oil is 85 to 95% eugenol. Isoeugenol and methyleugenol make up 5 to 15% of the remaining ingredients. Isoeugenol is manufactured from eugenol by a process of isomerization. Isoeugenol have been used in foods and eugenol has been used in animal feeds. Isoeugenol is used as a fish anesthetic. The mechanism of action of isoeugenol in fish has not been determined. It is hypothesised that its effects are mediated via receptors controlling cellular ion channels in a similar way to that described for local anaesthetics. Reports of adverse reactions involving the use of isoeugenol in humans are primarily confined to incidents of contact sensitization or allergy following dermal exposure.