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

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Showing 381 - 390 of 13311 results

Status:
US Approved OTC
Source:
21 CFR 349.16 ophthalmic:hypertonic agent sodium chloride
Source URL:
First marketed in 1921
Source:
Sodium Chloride U.S.P.
Source URL:

Class (Stereo):
CHEMICAL (ACHIRAL)

Status:
US Approved OTC
Source:
21 CFR 344.1 otic:earwax removal aid carbamide peroxide 6.5% (in anhydrous glycerin)
Source URL:
First marketed in 1921
Source:
Hydrogen Peroxide
Source URL:

Class (Stereo):
CHEMICAL (ACHIRAL)



Hydrogen peroxide has been used in medicine for more than 100 years. It is known in surgery as a highly useful irrigation solution by virtue of both its hemostatic and its antimicrobial effects. Hydrogen peroxide is a mild antiseptic used on the skin to prevent infection of minor cuts, scrapes, and burns. It may also be used as a mouth rinse to help remove mucus or to relieve minor mouth irritation (e.g., due to canker/cold sores, gingivitis). This product works by releasing oxygen when it is applied to the affected area. The release of oxygen causes foaming, which helps to remove dead skin and clean the area. Hydrogen peroxide is a strong oxidizing agent used in aqueous solution as a ripening agent, bleach, and topical anti-infective. It is relatively unstable and solutions deteriorate over time unless stabilized by the addition of acetanilide or similar organic materials.
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 (Stereo):
CHEMICAL (ACHIRAL)


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 OTC
Source:
21 CFR 331.11(a)(2) antacid:aluminum-containing aluminum hydroxide-magnesium trisilicate, co-dried gel
Source URL:
First marketed in 1921
Source:
Aluminum Hydroxide U.S.P.
Source URL:

Class (Stereo):
CHEMICAL (ACHIRAL)



Algeldrate (Aluminium hydroxide) is the amphoteric inorganic compound used as an antacid in the treatment of Duodenal, Peptic and Stomach Ulcer and some other conditions. Aluminium hydroxide is preferred over other alternatives such as sodium bicarbonate because Al(OH)3, being insoluble, does not increase the pH of stomach above 7 and hence, does not trigger secretion of excess acid by the stomach. Brand names include Alu-Cap, Aludrox, Gaviscon or Pepsamar. It reacts with the excess acid in the stomach, reducing the acidity of the stomach content, which may relieve the symptoms of ulcers, heartburn or dyspepsia. Such products can cause constipation, because the aluminum ions inhibit the contractions of smooth muscle cells in the gastrointestinal tract, slowing peristalsis and lengthening the time needed for stool to pass through the colon. Some such products (such as Maalox) are formulated to minimize such effects through the inclusion of equal concentrations of magnesium hydroxide or magnesium carbonate, which have counterbalancing laxative effects. This compound is also used to control phosphate (phosphorus) levels in the blood of people suffering from kidney failure. Precipitated aluminum hydroxide is included as an adjuvant in some vaccines (e.g. anthrax vaccine). One of the well-known brands of aluminum hydroxide adjuvant is Alhydrogel, made by Brenntag Biosector. Since it absorbs protein well, it also functions to stabilize vaccines by preventing the proteins in the vaccine from precipitating or sticking to the walls of the container during storage. Aluminium hydroxide is sometimes mistakenly called "alum", which properly refers to aluminum potassium sulfate. Vaccine formulations containing aluminum hydroxide stimulate the immune system by inducing the release of uric acid, an immunological danger signal. This strongly attracts certain types of monocytes which differentiate into dendritic cells. The dendritic cells pick up the antigen, carry it to lymph nodes, and stimulate T cells and B cells. It appears to contribute to induction of a good Th2 response, so is useful for immunizing against pathogens that are blocked by antibodies. In the 1960s and 1970s, it was speculated that aluminum was related to various neurological disorders including Alzheimer's disease. Since then, multiple epidemiological studies have found no connection between exposure to aluminum and neurological disorders.
Status:
US Approved OTC
Source:
21 CFR 333.210(d) antifungal povidone-iodine
Source URL:
First marketed in 1921

Class (Stereo):
CHEMICAL (ACHIRAL)

Conditions:

Tetraglycine hydroperiodide is an iodine-containing chemical, used for water purification. Tetraglycine hydroperiodide is marketed in tablets; each tablet effectively disinfects 1 liter of clear water or 0.5 liter of tainted water by releasing approximately 8 mg free iodine. It requires approximately 30 minutes to inactivate target microorganisms and make water bacteriologically suitable for drinking. To remove iodine taste, a vitamin C pill is added to the kit.
Status:
US Approved OTC
Source:
21 CFR 346.10(b) anorectal:local anesthetic benzyl alcohol
Source URL:
First marketed in 1921

Class (Stereo):
CHEMICAL (ACHIRAL)


Benzyl Alcohol is an aromatic alcohol used in a wide variety of cosmetic formulations as a fragrance component, preservative, solvent, and viscosity-decreasing agent. FDA agency approved benzyl alcohol for the treatment of head lice. The drug acts on head lice by inhibiting them from closing their respiratory spiracles, allowing the vehicle to obstruct the spiracles and causing the lice to asphyxiate.
Glycine (Cly) is a natural amino acid neurotransmitter that acts as a co-agonist at Glutamate [NMDA] receptors in the brain and is an activator of glycine receptors, GLRA1-3, GLRB. The abnormal Gly levels have been implicated in neuropsychiatric disorders. Alterations in Gly levels are implicated in several diseases of the central nervous system. Glycine was studied in phase II of clinical trials in patients with schizophrenia. The results have shown that using of glycine was associated with reduced symptoms with promising effect sizes and a possibility of improvement in cognitive function. Besides, glycine was also studied in clinical trials phase II in children with cystic fibrosis. The clinical, spirometric and inflammatory status of subjects with cystic fibrosis improved after just 8 weeks of glycine intake, suggesting that this amino acid might constitute a novel therapeutic tool for these patients. In addition, Gly was proposed as a biomarker for brain tumor malignancy. Glycine is a component of a nutrients mixture for peripheral administration to well-nourished mildly catabolic adult patients who require only short-term parenteral nutrition.
Menthyl lactate is derived from menthol, a compound that comes from peppermint oil, or is made synthetically. Menthol has a natural cooling effect, which makes it useful as a topical analgesic to treat skin irritation, pain, itching or sunburn. Despite its cooling benefits, menthol can be a skin irritant. Like menthol, menthyl lactate is cooling, but it causes less skin irritation than menthol. Menthyl lactate also has a refreshing, minty taste. For this reason, some manufacturers use it as a flavoring ingredient. The compound is recommended for use as a flavor in concentrations of 0.005% to 0.2% and in cosmetic and other external products in concentrations ranging from 0.2% to 2.0%. Menthyl lactate is a known compound available e.g. from Haarmann & Reimer GmbH (Germany) under the name FRESCOLAT, Type ML.
Status:
US Approved OTC
Source:
21 CFR 331.11(m) antacid:tartrate-containing tartrate (acid or salt)
Source URL:
First marketed in 1921
Source:
Tartaric Acid U.S.P.
Source URL:

Class (Stereo):
CHEMICAL (ABSOLUTE)

Conditions:

Tartaric acid is found in many plants such as grapes, tamarinds, pineapples, mulberries and so on. Wine lees (called mud in the US), the sediment collected during the fermentation of grapes, contains potassium bitartrate (potassium hydrogen tartrate) as its major component. L-(+)-tartaric acid is an enantiomer of tartaric acid. Twenty five years before the tetrahedral structure for carbon was proposed in 1874 to explain the optical activity and other properties of organic compounds, Louis Pasteur discovered the existence of enantiomerism in tartaric acid. L-(+)-tartaric acid is widely used in food and beverage as acidity regulator with E number E334.
Status:
US Approved OTC
Source:
21 CFR 341.16(d) cough/cold:bronchodilator epinephrine
Source URL:
First marketed in 1901

Class (Stereo):
CHEMICAL (ABSOLUTE)



Epinephrine is a sympathomimetic catecholamine. It acts as a naturally occurring agonist at both alpha and beta-adrenergic receptors. Three pharmacologic types have been identified: alpha 1-, alpha 2-, and beta-adrenergic receptors. Each of these has three subtypes, characterized by both structural and functional differences. The alpha 2 and beta receptors are coupled negatively and positively, respectively, to adenylyl cyclase via Gi or Gs regulatory proteins, and the alpha 1 receptors modulate phospholipase C via the Go protein. Subtype expression is regulated at the level of the gene, the mRNA, and the protein through various transcriptional and postsynthetic mechanisms. Through its action on alpha-adrenergic receptors, epinephrine lessens the vasodilation and increased vascular permeability that occurs during anaphylaxis, which can lead to loss of intravascular fluid volume and hypotension. Through its action on beta-adrenergic receptors, epinephrine causes bronchial smooth muscle relaxation and helps alleviate bronchospasm, wheezing and dyspnea that may occur during anaphylaxis. Epinephrine also alleviates pruritus, urticaria, and angioedema and may relieve gastrointestinal and genitourinary symptoms associated with anaphylaxis because of its relaxer effects on the smooth muscle of the stomach, intestine, uterus and urinary bladder. Epinephrine increases glycogenolysis, reduces glucose up take by tissues, and inhibits insulin release in the pancreas, resulting in hyperglycemia and increased blood lactic acid.