U.S. Department of Health & Human Services Divider Arrow National Institutes of Health Divider Arrow NCATS

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Showing 21 - 30 of 103 results

Status:
US Previously Marketed
Source:
Uval by Stuart
(1964)
Source URL:
First approved in 1964
Source:
Uval by Stuart
Source URL:

Class (Stereo):
CHEMICAL (ACHIRAL)

Conditions:

Sulisobenzone (benzophenone-4) is an ingredient for use in sunscreens which protects the skin from damage by UVB and short-wave UVA ultraviolet light. The Food and Drug Administration (FDA) has approved the use of Benzophenone-4 as safe and effective, over-the-counter (OTC) sunscreen ingredient. Sulisobenzone is a subject to the FDA 2011 sunscreen final rule: it can be marketed without approved drug applications (without NDAs or ANDAs), must bear the statement of identity “sunscreen" and contain the information about SPF test. However it is said to be widely used in cosmetic products not labeled as sunscreens such as creams, moisturizers, shampoos and other hair care products, nail polish, lipsticks and lip balms. Sulisobenzone may cause contact dermatitis when used in cosmetics and toiletries. Benzophenone 4 is tested as 10%. It was reported that 10% sulisobenzone enhance skin penetration of the moderately lipophilic herbicide 2,4-D.
Status:
US Previously Marketed
Source:
Indoklon by Ohio Medical Products
(1964)
Source URL:
First approved in 1964
Source:
Indoklon by Ohio Medical Products
Source URL:

Class (Stereo):
CHEMICAL (ACHIRAL)


Conditions:

Flurothyl (bis-2,2,2-trifluoroethyl ether) is a volatile convulsant acting as a GABAA antagonist that was extensively used historically to induce seizures in severely depressed patients as an alternative to electroconvulsive shock therapy. The main current use of flurothyl is in scientific research for inducing seizures in laboratory animals. Flurothyl is used to induce seizures in immature rats. Flurothyl is a potent and rapidly acting central nervous system stimulant that produces seizures within minutes of exposure. It has been previously demonstrated that flurothyl seizures during the first days and weeks of life in rats result in several morphological and behavioral changes. Mortality after acute flurothyl exposure is low.
Status:
US Previously Marketed
First approved in 1964

Class (Stereo):
CHEMICAL (ACHIRAL)



Acetohexamide (trade name Dymelor) is a first-generation sulfonylurea medication used to treat diabetes mellitus type 2, particularly in people whose diabetes cannot be controlled by diet alone. It lowers blood sugar by stimulating the pancreatic beta cells to secrete insulin and by helping the body use insulin efficiently. The pancreas must produce insulin for this medication to work. Acetohexamide binds to an ATP-dependent K+ channel on the cell membrane of pancreatic beta cells. This inhibits a tonic, hyperpolarizing out flux of potassium, which causes the electric potential over the membrane to become more positive. This depolarization opens voltage-gated Ca2+ channels. The rise in intracellular calcium leads to increased fusion of insulin granule with the cell membrane, and therefore increased secretion of (pro) insulin. Acetohexamide extensively metabolized in the liver to the active metabolite hydroxyhexamide, which exhibits greater hypoglycemic potency than acetohexamide. Hydroxyhexamide is believed to be responsible for prolonged hypoglycemic effects. Symptoms of an acetohexamide overdose include hunger, nausea, anxiety, cold sweats, weakness, drowsiness, unconsciousness, and coma. Acetohexamide has been discontinued in the US market.
Status:
US Previously Marketed
First approved in 1964
Source:
Anavar by Searle
Source URL:

Class (Stereo):
CHEMICAL (ABSOLUTE)



Oxandrolone is a synthetic, orally active anabolic-androgenic steroid. Oxandrolones interact with androgen receptors in target tissues. Oxandrin is indicated as adjunctive therapy to promote weight gain after weight loss following extensive surgery, chronic infections, or severe trauma, and in some patients who without definite pathophysiologic reasons fail to gain or to maintain normal weight, to offset the protein catabolism associated with prolonged administration of corticosteroids, and for the relief of the bone pain frequently accompanying osteoporosis. Side effects include: elevated aminotransferases (ALT, AST), lipid abnormalities (e.g., decreased HDL cholesterol concentrations). Cardiovascular side effects have included edema, with and without congestive heart failure. Oxandrolone may inhibit the metabolism of oral hypoglycemic agents. In patients with edema, concomitant administration with adrenal cortical steroids or ACTH may increase the edema.
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:
Photoplex by Herbert
(1988)
Source URL:

Class (Stereo):
CHEMICAL (RACEMIC)


Padimate O is an organic compound related to the water-soluble compound PABA (4-aminobenzoic acid) that is used as an ingredient in some sunscreens. this chemical releases free radicals, damages DNA, has estrogenic activity, and causes allergic reactions in some people. Maximum FDA-approved concentration - 8%. Range of protection - UVB.
Status:
Possibly Marketed Outside US

Class (Stereo):
CHEMICAL (ACHIRAL)

Sodium dithionate is a very stable inorganic compound, which is not oxidized by permanganate, dichromate or bromine. The use of sodium dithionate is being criticized for the formation of non-environment friendly decomposition products such as sulphite, sulphate, thiosulphate and toxic sulphur.
Status:
Possibly Marketed Outside US
Source:
Canada:ETHYL ACETATE
Source URL:
First approved in 1964
Source:
Stop-A-Leak by H. W. Naylor Company Inc.
Source URL:

Class (Stereo):
CHEMICAL (ACHIRAL)

Conditions:

Ethyl acetate is a widely used synthetic solvent. It is used in cosmetics and considered to be safe. Ethyl acetate is cited as a direct and indirect food additive as detailed in the Code of Federal Regulations. Ethyl acetate is generally recognized as safe (GRAS) for use as a synthetic flavor and/or adjuvant; limitations on concentrations of use were not specified. Ethyl acetate was tested for in vitro in human breast cancer cell line and demonstrated considerable cytotoxicity.
Tocophersolan (Vedrop, tocofersolan) or d-alpha-Tocopheryl Polyethylene Glycol 1000 Succinate (TPGS) is a watersoluble derivative of the natural active (d-alpha) isomer of vitamin E. The active constituent of the medicinal product is essentially vitamin E (alpha tocopherol). Chronic congenital or hereditary cholestasis is a clinical condition where vitamin E deficiency results from an impaired bile secretion. Decreased intestinal absorption observed in chronic congenital or hereditary cholestatic patients is due to decreased bile secretion and the resulting decrease in intestinal cellular absorption. As a result, fatsoluble vitamins (i.e. vit. E) are not absorbed properly and deficiency can occur. Tocophersolan (Vedrop) is used to treat or prevent vitamin E deficiency (low vitamin E levels). It is used in children up to the age of 18 years who have congenital or hereditary chronic cholestasis and who cannot absorb vitamin E from the gut. Tocophersolan (Tocofersolan) can be absorbed from the gut in children who have difficulty absorbing fats and vitamin E from the diet. This can increase vitamin E levels in the blood and help to prevent neurological deterioration (problems in the nervous system) due to vitamin E deficiency. No treatment-related findings were reported, as all clinical observations and findings at autopsy were similar in treatment and control groups. In many of the studies, the LD50 was not determined as tocofersolan was well tolerated.
Status:
Possibly Marketed Outside US
Source:
UDDER BALM by H. W. Naylor Company Inc.
(1964)
Source URL:
First approved in 1964
Source:
UDDER BALM by H. W. Naylor Company Inc.
Source URL:

Class (Stereo):
CHEMICAL (ACHIRAL)