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Search results for amphotericin root_codes_comments in Code Comments (approximate match)
Status:
US Approved OTC
Source:
21 CFR 331.11(i)(2) antacid:calcium-containing calcium (mono or dibasic salt)
Source URL:
First marketed in 1921
Source:
Syrup of Calcium Iodide N.F.
Source URL:
Class:
MIXTURE
Conditions:
Calcium lactate is the salt that consists of two lactate anions for each calcium cation (Ca2+); this salt is used as a calcium supplement to treat hypocalcemia. However, as a source of free calcium, this salt is less convenient than calcium citrate. Calcium lactate inhalation powder also called as PUR118 participated in phase I clinical trials to determine whether this formulation was safe and tolerable in a population of subjects with Cystic Fibrosis (CF). PUR118 also was used in another clinical trials to evaluate its effect on ozone-induced airway Inflammation in healthy normal volunteers in case of Chronic Obstructive Pulmonary Disease (COPD). The obtained results revealed that PUR118 reduced the severity of acute exacerbations in COPD and CF and had the beneficial impacts on mortality, morbidity, and quality of life in affected individuals. However, both studies were discontinued.
Status:
US Approved Allergenic Extract
(1994)
Source:
BLA103738
(1994)
Source URL:
First approved in 1994
Source:
BLA103738
Source URL:
Class:
MIXTURE
Conditions:
Quaternium-15, a preservative, is one of the most used substances and is added to several cosmetics and other industrial products. Quaternium-15 is a mixture of
isomers, where the cis-form is the dominant form and where the trans-form is the minor
component present as an impurity.
Quaternium-15 can be found under a variety of names, most commonly those of the Dow Chemical Company: Dowicil 200 (cis isomer only), Dowicil 75 and Dowicil 100 (both a mix of cis and trans isomers). The isolated cis-compound is used primarily in cosmetic applications, with a maximum permitted concentration in the EU of 0.2%. DOWICIL 200 preservative (cis form) is used primarily as a preservative in a wide variety of personal-care
and cosmetic products. It is designed to provide highly effective broad-spectrum antimicrobial
activity, especially in water-based formulations. It is used in both leave-on and rinse-off
application such as baby-care products, hair-care products, lotions, powders, and creams.
The mixed product (cis- and trans-) is used in a wider range of formulations such as: emulsifiable metal-cutting fluids; latex and emulsion paints; liquid floor polishes and floor waxes; glues and adhesives. Recently, the cis-form has been classified as a CMR substance with the classification
toxic to reproduction, category 3. This classification only concerns the cis-isomer:
Status:
US Previously Marketed
Source:
21 CFR 310.545(a)(18)(v)(B) skin protectant:insect bites/stings w/ sales less than $25,000 glyceryl stearate
Source URL:
First approved in 1971
Source:
ANDA090256
Source URL:
Class:
MIXTURE
Conditions:
Glyceryl 1-stearate (Glycerol monostearate), commonly known as GMS, is an organic molecule used as an emulsifier. GMS is a white, odorless, and sweet-tasting flaky powder that is hygroscopic. It is a glycerol ester of stearicacid. It occurs naturally in the body as a product of the breakdown of fats by pancreatic lipase, and is also found in fatty foods. GMS is a food additive used as a thickening, emulsifying, anti-caking, and preservative agent; an emulsifying agent for oils, waxes, and solvents; a protective coating for hygroscopic powders; a solidifier and control release agent in pharmaceuticals; and a resin lubricant. It is also used in cosmetics and hair care products. Used in antiperspirants and deodorants, baby care, body care, facial care, sun care, conditioners, facial make-up, creams and lotions-skin care, sprayable emulsions, feet, hands and nails, self-tanning, nail grooming and color cosmetics. GMS is largely used in baking preparations to add "body" to the food. It is responsible for giving ice cream and whipped cream its smooth texture. It is sometimes used as an anti-staling agent in bread. Glycerol 1-stearate is affirmed by FDA as GRAS.
Status:
US Previously Marketed
Source:
Solution of Potassium Arsenite U.S.P.
(1921)
Source URL:
First marketed in 1921
Source:
Solution of Potassium Arsenite U.S.P.
Source URL:
Class:
MIXTURE
Arsenite ion is a form of inorganic trivalent arsenic. It is derived from arsenous acid and known mainly for forming the basis of Fowler's solution (1% potassium arsenite (KAsO2). Fowler's solution has had a fascinating history in medicine during the past 200 years. The use of Fowler's solution was first described and published as a treatment for malaria and syphilis in the late 1700s. Many clinical applications for Fowler's solutions have been studied and utilized over the years, but toxicities have limited its utility. Even so, arsenic trioxide, chemically related to Fowler's solution, was approved by the US Food and Drug Administration for treating acute promyelocytic leukemia. The chronic arsenic exposure is a cause of immense health distress as it accounts for the increased risk of various disorders such as cardiovascular abnormalities, diabetes mellitus, neurotoxicity, and nephrotoxicity. In addition, the exposure to arsenic has been suggested to affect the liver function and to induce hepatotoxicity. Moreover, few studies demonstrated the induction of carcinogenicity especially cancer of the skin, bladder, and lungs after the chronic exposure to arsenic.
Status:
US Previously Marketed
First marketed in 1921
Class:
MIXTURE
Status:
US Previously Marketed
Source:
Sugar of Milk U.S.P.
(1921)
Source URL:
First marketed in 1921
Class:
MIXTURE
Targets:
Conditions:
Lactose is the most important carbohydrate in the milk of most species. Its biosynthesis takes place in the mammary gland. The molecular structures of α- and β -lactose differ in the orientation of a hydrogen- and a hydroxyl group on carbon atom no.1 in the glucose moiety. Both forms change into one another continuously. At room temperature, the equilibrium results in a ratio of about 40% α-lactose and 60% β-lactose. The fact that two forms of lactose exist which differ in molecular structure has profound effects on various properties of lactose such as crystallization behavior, crystal morphology, solid-state properties, and solubility. The intestine does not actively absorb lactose unless it is split into its two-monosaccharide components, i.e. glucose and galactose. This hydrolysis of lactose is affected by the enzyme lactase, which is produced by the epithelium cells in the brush-border of the small intestine. Thus, the capacity of mammals to digest lactose is dependent on the lactase activity in the intestine. The maximum activity of the enzyme occurs shortly after birth and declines during the weaning period, after which it remains at a relatively constant level. Genetically determined factors governing residual lactase activity also exist. Individuals having low lactase activity are called lactose malabsorbers. Lactose intolerance is a condition in which people have symptoms due to the decreased ability to digest lactose. The principal symptom of lactose intolerance is an adverse reaction to products containing lactose (primarily milk), including abdominal bloating and cramps, flatulence, diarrhea, nausea, borborygmi, and vomiting (particularly in adolescents). These appear one-half to two hours after consumption.
Status:
Possibly Marketed Outside US
First approved in 2022
Source:
21 CFR 350
Source URL:
Class:
MIXTURE
Targets:
Conditions:
Aconitic Acid found in leaves and tubers of Aconitum napellus L., Ranunculaceae, in various species of Achillea (Compositae) and Equisetum (Equisetaceae), in beet root, and in sugar cane. It is indicated for the temporary relief of symptoms of chronic illness including fatigue, effects of toxin buildup, slowed metabolism, weakened constitution. The limited data on trans-aconitic acid indicate it to be less toxic than citric acid. Trans-aconitate salts appear to be excreted readily by the kidneys. There is no direct evidence that trans-aconitic acid is utilized as is the cis-aconitic acid isomer in mammalian metabolism although non-specific oxidation probably occurs.
Status:
Possibly Marketed Outside US
Source:
Disinfecting Wipes by NANOFIXIT VENTURES INC.
(2020)
Source URL:
First approved in 2012
Source:
505G(a)(3)
Source URL:
Class:
MIXTURE
Status:
Possibly Marketed Outside US
Source:
Volu-Firm Day Cream Sunscreen Broad-Spectrum SPF 30
Source URL:
First approved in 2005
Source:
21 CFR 352
Source URL:
Class:
MIXTURE
Conditions:
Status:
Possibly Marketed Outside US
Source:
21 CFR 352
(2015)
Source URL:
First approved in 1989
Source:
ANDA205563
Source URL:
Class:
MIXTURE
Monoglyceride citrate is a food additive that used as solubilizer and synergist for flavors and antioxidants. Monoglyceride citrate is effective to stabilize food such as margarine or mayonnaise, coffee creamers, and peanut butter.