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Status:
Possibly Marketed Outside US
Source:
24 HOUR PIMPLE PUNISHER
Source URL:
First approved in 2003
Source:
21 CFR 358H
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Oleanolic acid or oleanic acid is a naturally occurring pentacyclic triterpenoid. It is widely distributed in food and plants where it exists as a free acid or as an aglycone of triterpenoid saponins. Oleanolic acid protects the liver from acute chemically induced liver injury, fibrosis and cirrhosis caused by chronic liver diseases. Its possess cytotoxic activity against tumor cell lines
Status:
Possibly Marketed Outside US
Source:
NCT03626298: Phase 4 Interventional Completed Acne Vulgaris
(2016)
Source URL:
First approved in 2002
Source:
M006
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Zinc Pidolate (Zinc PCA) is a topical skin product with purifying, astingent, anti-inflammatory, antiseptic activity. It has long been used as a cosmetic ingredient, because of its astringent and anti-microbial properties. Zinc Pidolate has also being shown to be effective against halitosis. Zinc PCA prevents the UV-induced MMP-1 production in vitro by suppressing the activation of AP-1. Zinc PCA was also able to enhance type I collagen synthesis in NHDFs, by increasing the expression of the mRNA encoding the ascorbic acid transporter SVCT2 in non-UV irradiated
NHDFs, which suggests its promising effect against not only photoaged skin but also for the simple atrophic change of intrinsic skin ageing. Zinc PCA is able to suppress sebum secretion by inhibiting 5-α reductase in hyperseborrhea, to suppress body odor by forming zinc salts with short-chain fatty acids, to suppress wrinkles by inhibiting AP-1 to and inhibit bacterial growth including acne related Propionibacterium acnes.
Status:
Possibly Marketed Outside US
Source:
CheryLee MD TrueLipids Relieve and Protect Ointment by Zellner, J.
Source URL:
First approved in 2002
Source:
M020
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Phytosphingosine is structural analog of sphingolipids and is classified as long-chain sphingoid base. Phytosphingosine significantly induced chromatin DNA fragmentation. Phytosphingosine caused strong induction of caspase-8 activity and caspase-independent Bax translocation to the mitochondria. It shows excellent clinical results in the context of skin care in acne, based on both anti-inflammatory and anti-microbial activity. Phytosphingosine is currently seen in a variety of products as a skin and hair conditioning agent. Phytosphingosine might serve as an effective melanogenesis inhibitor in melanocytes via the regulation of the MITF signaling pathways. Dietary supplementation of phytosphingosine decreases plasma cholesterol levels and enhances insulin sensitivity in men with the metabolic syndrome.
Status:
Possibly Marketed Outside US
Source:
M001
(2019)
Source URL:
First approved in 2001
Source:
ANDA086069
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Tert-butylhydroquinone (tBHQ) or 2-(1,1-dimethylethyl)-1,4-benzenediol is an antioxdant found to inhibit lipid oxidation. Extensive studies have demonstrated that tBHQ exhibit anti-carcinogenic effect. The ability of tBHQ to induce phase II xenobiotic metabolizing enzymes through an Nrf2-dependent pathway is thought to be responsible for the observed protective effect of tBHQ. It has been proposed that tBHQ enhances Nrf2-mediated transcription by promoting reactive oxygen species-mediated dissociation of Nrf2-Keap1, Nrf2 stabilization, phosphatidylinositol 3-kinase (PI3K)/Akt activity, and MAPK pathway activation. tBHQ has been commonly used as a synthetic food additive to prevent oils and fats from oxidative deterioration and rancidity due to its potent anti-lipid peroxidation activity.
Status:
Possibly Marketed Outside US
Source:
21 CFR 352
(2011)
Source URL:
First approved in 2000
Source:
21 CFR 352
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Ubiquinone Q2 (CoQ(2)) is a member of the chemical class known as Polyprenylbenzoquinones. These are compounds containing a polyisoprene chain attached to a quinone at the second ring position. Ubiquione-2 has just 2 isoprene units. Normally in humans it has 10. Ubiquinone-2 is an intermediate in the synthesis of Ubiquionone 10. Ubiquionone is involved in cellular respiration. It is fat-soluble and is therefore mobile in cellular membranes; it plays a unique role in the electron transport chain (ETC). In the inner bacterial membrane, electrons from NADH and succinate pass through the ETC to the oxygen, which is then reduced to water. The transfer of electrons through ETC results in the pumping of H+ across the membrane creating a proton gradient across the membrane, which is used by ATP synthase (located on the membrane) to generate ATP. The first ubiquinone was isolated in 1957. Since that time, ubiquinones have been extensively studied in Japan, Russia, and Europe with research in the US beginning more recently. Popular press accounts claim that roughly 12 million Japanese use ubiquinones as the medication of choice for management of cardiovascular diseases, with more than 250 commercially available preparations. Ubiquinone is touted as an effective treatment of congestive heart failure (CHF), heart rhythm irregularities, high blood pressure, and in reducing injury to the heart muscle caused by lack of oxygen. Other claims include increasing exercise tolerance, stimulating the immune system, and counteracting the aging process. Ubiquinone has not been approved for therapeutic use in the US, but it is available as a food supplement. Ubiquinone may have applications in heart disease, especially CHF, although there is a lack of consensus. Studies in neurological disorders are less promising. Limited clinical trials have been conducted to support its widespread use for other conditions.
Status:
Possibly Marketed Outside US
First approved in 2000
Source:
21 CFR 348
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Targets:
Conditions:
Borneol, a monoterpenoid alcohol, is a component of many essential oils. Barneol occurs in nature as a single enantiomer (d- or l-, depending on the oil type) or, less frequently, as the racemate. Several studies have proved the effectiveness of borneol. In Chinese medicines borneol has been used in relieving symptoms of anxiety, fatigue and insomnia; inducing anesthesia and analgesia to alleviate abdominal pain, wounds and burns; relieving rheumatic pain, hemorrhoids, skin diseases and ulcerations of the mouth, ears, eyes or nose; to treat sore throats and skin infections, and is mainly used to treat cardiovascular and cerebrovascular diseases. Borneol has a significant therapeutic effect on neuralgia. This compound is considered a GRAS approved by the FDA as food flavor. Additionally, borneol is a fragrance ingredient. GABAA, TRPV3, TRPM8 and TRPA1 have been identified as the molecular targets of borneol.
Status:
Possibly Marketed Outside US
First approved in 1999
Source:
KeratexKNHD by Penleigh Irving Ltd
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Limonene is a naturally occurring chemical which is used in many food products, soaps and perfumes for its lemon-like flavor and odor. Limonene also is a registered active ingredient in 15 pesticide products used as insecticides, insect repellents, and dog and cat repellents. Pesticide products containing limonene are used for flea and tick control on pets, as an insecticide spray, an outdoor dog and cat repellent. It has also been used for relief of heartburn and gastroesophageal reflux (GERD). D-limonene has well-established chemopreventive activity against many types of cancer. Limonene and its oxidation products are skin and respiratory irritants.
Status:
Possibly Marketed Outside US
First approved in 1996
Source:
NADA141061
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Doramectin is a macrocyclic lactone isolated from fermentations of selected strains derived from the soil organism Streptomyces avermitilis. A primary mode of action of macrocyclic lactones is to modulate chloride ion channel activity in the nervous system of nematodes and arthropods. Macrocyclic lactones bind to receptors that increase membrane permeability to chloride ions. This inhibits the electrical activity of nerve cells in nematodes and muscle cells in arthropods and causes paralysis and death of the parasites. Doramectin is indicated for the treatment and control of gastrointestinal roundworms, lungworms, eyeworms, grubs, biting and sucking lice, horn flies, and mange mites in cattle.
Status:
Possibly Marketed Outside US
Source:
NCT04677712: Phase 4 Interventional Completed Edematous Fibrosclerotic Panniculopathy (EFP)
(2020)
Source URL:
First approved in 1996
Source:
Strovite Forte Caplet by Everett Laboratories, Inc.
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Ascorbyl palmitate is a fat soluble vitamin C ester. An ester is simply a compound formed by the combination of an organic acid and an alcohol – in this case it is ascorbic acid and palmitic acid (a fat – which is composed of fatty acids and glycerol - an alcohol). Therefore, ascorbyl palmitate is formed by the esterification of ascorbic acid with palmitic acid to form vitamin C ester. Ascorbyl palmitate is an amphipathic molecule, meaning one end is water-soluble and the other end is fat-soluble. This dual solubility allows it to be incorporated into cell membranes. When incorporated into the cell membranes of human red blood cells, ascorbyl palmitate has been found to protect them from oxidative damage and to protect alpha-tocopherol (a fat-soluble antioxidant) from oxidation by free radicals. Basically, the fat-soluble aspect of ascorbyl palmitate extends vitamin C free radical protection into the fat parts of the body. However, the protective effects of ascorbyl palmitate on cell membranes have only been demonstrated in the test tube (in vitro). Taking ascorbyl palmitate orally may not result in any significant incorporation into cell membranes because most of it appears to be hydrolyzed (broken apart into palmitate and ascorbic acid) in the human digestive tract before it is absorbed. The ascorbic acid released by the hydrolysis of ascorbyl palmitate appears to be as bioavailable as ascorbic acid alone. The presence of ascorbyl palmitate in oral supplements contributes to the ascorbic acid content of the supplement and probably helps protect fat-soluble antioxidants in the supplement. This is also true for food products. Ascorbyl palmitate is used to increase the shelf life of vegetable oils and potato chips. The role of vitamin C in promoting collagen synthesis and its antioxidant properties have generated interest in its use on the skin. Ascorbyl palmitate is frequently used in topical preparations because it is more stable than some aqueous (water-soluble) forms of vitamin C. It is also suggested that this form of vitamin C is better able to penetrate the skin and the thin membrane of cells (due to its dual solubility), which can then go on to help produce collagen and elastin.
Status:
Possibly Marketed Outside US
Source:
Maltos-10 by Otsuka [Japan]
Source URL:
First approved in 1995
Source:
BLA103649
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Maltose, a disaccharide, is found mainly in grains and cereals. Nutritionally, maltose provides the same number of calories as starches and other sugars. Maltose can be the agent responsible for the primary signals to induce the sensations of hunger and satiation in human beings. It was shown, that parenterally administered maltose could be of clinical value.