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Status:
US Approved Allergenic Extract
(1994)
Source:
BLA103738
(1994)
Source URL:
First marketed in 1921
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Cobalt is a transition metal, naturally ocurring in the minerals cobaltite, smaltite, and erythrite, and is often associated with nickel, silver, lead, copper, and iron ores, from which it is most frequently obtained as a by-product. Depending on the considered species, cobalt has multiple industrial applications including the production of alloys and hard metal, diamond polishing, drying agents, pigments and catalysts. Cobalt is an essential component of Vitamin B12 (hydroxycolalamin). Cobalt functions as a co-factor in enzyme catalysed reactions and is involved in the production of erythropoietin, a hormone that stimulates the formation of erythrocytes. Cobalt salts were used to treat anemia and stimulate erythropoiesis, but was withdrawn from market since Co(II) cations are genotoxic in vitro and in vivo, and carcinogenic in rodents. Hovewer, Co salts are reported to be used by athletes as a doping
Status:
US Previously Marketed
Source:
21 CFR 310.536(a) nailbiting or thumbsucking deterrent sucrose octaacetate
Source URL:
First approved in 2015
Source:
Benzalkonium Chloride, Benzyl Alcohol by Meridian Animal Health
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Sucrose octaacetate is an acetylated derivative of sucrose. It can be used as a bitter additive, a denaturant for alcohol, a soaker for paper, as well as an insecticide, plasticizer for cellulosic&synthetic resin. It also can be used as an additive for paint and children's toys, etc. It can prevent mice or children from biting or tasting the goods because of its extreme bitter taste. Sucrose octaacetate was determined by the EPA to be usable as an inert ingredient in pesticides due to its low toxicity
Status:
US Previously Marketed
Source:
INGENOL MEBUTATE by PADAGIS ISRAEL
(2019)
Source URL:
First approved in 2012
Source:
PICATO by LEO LABS
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Ingenol is an extremely weak PKC (protein kinase C) activator, with potent anticancer activity. Ingenol derivatives have received constant and multidisciplinary attention on account of their pleiotropic pattern of biological activity. This includes activation of PKC (protein kinase C), tumor-promotion, anticancer, and anti-HIV properties, and the possibility of dissecting co-cancerogenic and clinically useful activities has been demonstrated. Certain ingenol esters show powerful anticancer activity, and a structure-activity relationship model to discriminate between their apoptotic and non-apoptotic properties has been developed.
Status:
US Previously Marketed
Source:
SYNRIBO by TEVA PHARMS INTL
(2012)
Source URL:
First approved in 2012
Source:
SYNRIBO by TEVA PHARMS INTL
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Conditions:
Omacetaxine mepesuccinate (trade name Synribo) formerly named as homoharringtonine or HHT, is a pharmaceutical drug substance that is indicated for treatment of chronic myeloid leukemia (CML). It is a natural ester of the alkaloid cephalotaxine from Cephalotaxus harringtonia, now manufactured by hemi-synthesis. It was approved by the US FDA in October 2012 for the treatment of adult patients with CML with resistance and/or intolerance to two or more tyrosine kinase inhibitors (TKIs). The mechanism of action of omacetaxine mepesuccinate has not been fully elucidated but includes inhibition of protein synthesis and is independent of direct Bcr-Abl binding. Omacetaxine mepesuccinate binds to the A-site cleft in the peptidyl-transferase center of the large ribosomal subunit from a strain of archaeabacteria. In vitro, omacetaxine mepesuccinate reduced protein levels of the Bcr Abl oncoprotein and Mcl-1, an anti-apoptotic Bcl-2 family member. Omacetaxine mepesuccinate showed activity in mouse models of wild-type and T315I mutated Bcr-Abl CML.
Status:
US Previously Marketed
Source:
21 CFR 310.545(a)(18)(v)(B) skin protectant:insect bites/stings w/ sales less than $25,000 isopropyl palmitate
Source URL:
First approved in 1996
Source:
Hydrocortisone Acetate Pramoxine Hcl by Padagis Israel Pharmaceuticals Ltd
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Isopropyl palmitate is the ester of isopropyl alcohol and palmitic acid. It is an emollient, moisturizer, thickening agent, and anti-static agent. Isopropyl Palmitate is a traditional, fast spreading emollient for modern cosmetic applications. Isopropyl palmitate is approved by ECOCERT for Natural and Organic Cosmetics. It is on FDA CFR - Code of Federal Regulations Title 21 list.
Status:
US Previously Marketed
Source:
21 CFR 310.545(a)(22)(ii) antifungal:diaper rash methylparaben
Source URL:
First approved in 1987
Source:
NDA019527
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Methylparaben (E number E218) is preservative in the food, cosmetic, and pharmaceutical industries. It is completely absorbed through the skin or after ingestion and and it is hydrolyzed to para-hydroxybenzoic acid, and metabolites are rapidly excreted in the urine. Methylparaben is on the FDA generally regarded as safe list.
Status:
US Previously Marketed
Source:
21 CFR 310.545(a)(7) dandruff captan
Source URL:
First approved in 1983
Source:
ANDA088228
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Captan is a fungicide. It is used on a variety of agricultural and greenhouse food/feed crops, indoor non-food uses, seed treatments and ornamental plant sites. People who mixed captan products or worked in fields where captan had been applied reported eye and skin irritation. A few human volunteers reported skin irritation and allergic reactions after captan was applied to their backs. Captan was previously cited as Group B2, a probable human carcinogen by the US Environmental Protection Agency (EPA), but was reclassified in 2004. The EPA now states: “Captan is not likely to be a human carcinogen nor pose cancer risks of concern when used in accordance with approved product labels.”
Status:
US Previously Marketed
Source:
21 CFR 310.545(a)(22)(ii) antifungal:diaper rash benzoxiquine
Source URL:
First approved in 1964
Source:
UDDER BALM by H. W. Naylor Company Inc.
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
In cosmetics and personal care products, Benzoxiquine has been reported to be used in the formulation of hair tonics, dressings, and other hair grooming aids. Benzoxiquine is described as a biocide for use in cosmetic products. It is currently reported to be used in only one product. In a separate finding, the Food and Drug Administration determined that Benzoxiquine is not generally recognized as safe and effective in over-the-counter topical antifungal drug products. The only data available on the toxicity of Benzoxiquine indicates that it is mutagenic in the Ames test without metabolic activation. Because of the lack of data, the safety of Benzoxiquine could not be substantiated. The data needed to make a safety assessment include purity/impurities, ultraviolet absorption (if there is absorption, then photosensitization data will be needed), 28-day dermal toxicity, dermal teratogenicity, ocular irritation (if already available only), dermal irritation and sensitization, and two different genotoxicity studies (one using a mammalian system). If the latter data are positive, dermal carcinogenesis data using the methods of the National Toxicology Program will be needed. It cannot be concluded that Benzoxiquine is safe for use in cosmetic products until these safety data have been obtained and evaluated.
Status:
US Previously Marketed
Source:
Stop-Zit by Nelson Baker & Company
(1962)
Source URL:
First approved in 1962
Source:
Stop-Zit by Nelson Baker & Company
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Denatonium, usually available as denatonium benzoate (trade names Bitrex) is the most bitter chemical compound known, with bitterness thresholds of 0.05 ppm for the benzoate and 0.01 ppm for the saccharide. Scientists at Macfarlan Smith, Ltd. of Edinburgh, Scotland discovered Bitrex during research on derivatives of the anesthetic lidocaine. The extremely bitter taste proved effective in reducing ingestion by humans and animals. Denatonium is commonly included in placebo medications used in clinical trials to match the bitter taste of certain medications. Denatonium activates bitter taste receptor, mainly, TAS2R4, TAS2R8, TAS2R10, TAS2R13 on many cell types and plays important roles in chemical release, ciliary beating and smooth muscle relaxation through intracellular Ca(2+)-dependent pathways.
Status:
US Previously Marketed
First approved in 1961
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Cinoxate, a cinnamate, is a potent ultraviolet absorber at 289 nm. It is approved by FDA as the active ingredient in sunscreen compositions for over-the-counter (OTC) use at concentrations up to 3% and a minimum SPF value of not less than 2 in the finished product but is rarely used It can cause photoallergic contact dermatitis.