Tolindate, a thiocarbamate, is a synthetic antifungal approved by FDA as an over-the-counter (OTC) drug product and is marketed by Norcliff Thayer Inc. It was prepared by treating 5-indanyl thionochloroformate with N-methyl-m-toluidine and patented in 1970 by USV Pharmaceutical Corporation tas a compound with strong topical antifungal activity that may be administered topically in the form of ointments and solutions. It was used in eastern Europe as Dalnate (USV Pharmaceutical Corporation trademark registerd in 6/26/1973) for topical application in the treatment of various dermatoses. Produced by ZORKA Pharma (at present Hemofarm a.d., Serbia) topical cream or solution Dalnate was registered for marketing in Russia.

Antimicrobial agent Fluorosalan is classified as Category II for use as antiseptic handwash, healthcare personnel handwash, patient preoperative skin preoperative skin preparation, and surgical hand scrub products. In the 1994 TFM (59 FR 31402 at 31435-31436), FDA proposed that the active ingredient fluorosalan be found not GRAS/GRAE for the uses referred to in the 1994 TFM as antiseptic hand wash and health care personnel hand wash.

This chemical compound was studied the Japan. According this investigation, there is no available information on toxicokinetics and metabolism of 6-tert-Butyl-m-cresol. The LD50 values for acute toxicity of this substance were between 320 and 800 mg/kg in males and between 130 and 320 mg/kg in females for rats, and 580 mg/kg in males and 740 mg/kg in females for mice. This substance is corrosive to skin and eyes in rabbits. However, no irritation problem has been reported at any production site where workers wear proper clothing and equipment. A reproductive toxicity study in rats revealed that this substance was toxic to the dams at 60 mg/kg, causing depression of body weight gain and a slight decrease in the number of corpora lutea and implantations. This effect in the dams influenced the outcome of pregnancy, seen as a decrease in the number of live births and depression of weight gain in the offspring. These effects were not seen at 12.5 mg/kg/day. No evidence of gross malformations was observed at any dose. Based on these findings, the NOAEL for reproductive toxicity is considered to be 12.5 mg/kg/day for both female parents and pups. Evidence of malformations was not observed at any dose.

Nigericin is an antibiotic derived from Streptomyces “Nig-1”. It is the potassium ionophore and H+/K+ exchanger. It is shown to be highly effective as an ionophore for Pb(2+). Thus, nigericin may be more useful than monensin in the treatment of Pb intoxication. Nigericin induced mitochondrial membrane hyperpolarization. Malignant characteristics of human glioma cells were markedly suppressed by nigericin treatment in vivo. Nigericin induces cell death and promotes the maturation and release of IL-1beta in lipopolysaccharide (LPS)-primed monocytes and macrophages. The mechanism of induction of apoptosis by nigericin is most probably to decrease intracellular pH.

FERRICLATE CALCIUM SODIUM is a hematinic agent.

Safrole is a natural product obtained from essential oil of the root bark of Sassafras tree. Safrole has been used as a flavoring agent in drugs and in the manufacture of heliotropin, perfumes, soaps, and piperonyl butoxide. Oil of sassafras, which contains safrole, was formerly used to flavor some soft drinks, such as root beer. However, this use or any other addition of safrole or oil of sassafras to food was banned in the United States in 1960 due to evidence of carcinogenicity. Numerous studies have shown that safrole from betel quid-containing safrole might be involved in the pathogenesis of hepatocellular carcinoma in human due to the formation of DNA adducts. Safrole has also been used in the illicit production of the drug 3,4-methylenedioxymethamphetamine (MDMA, or ecstasy), and the U.S. Drug Enforcement Administration has designated safrole a List I Chemical. Anticancer and anti-diabetic properties of safrole were investigated in vitro and in vivo.