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Search results for m root_Display\ Name in Display Name (approximate match)
Status:
US Approved Rx
(2023)
Source:
ANDA215469
(2023)
Source URL:
First marketed in 1921
Source:
Potassium Sulphate N.F.
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
SULFATE (as sodium sulfate, potassium sulfate, and magnesium sulfate) is a component of SUPREP Bowel Prep Kit. It is an osmotic laxative indicated for cleansing of the colon in preparation for colonoscopy in adults. Sulfate salts provide sulfate anions, which are poorly absorbed. The osmotic effect of unabsorbed sulfate anions and the associated cations causes water to be retained within the gastrointestinal tract. SUPREP Bowel Prep Kit, when ingested with a large volume of water, produces copious watery diarrhea.
Status:
US Approved Rx
(1984)
Source:
ANDA088638
(1984)
Source URL:
First marketed in 1921
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Acetic acid (a component of vinagre) is used in medicine for the treatment of otitis externa caused by bacterial infections. The solution containing acetic acid was approved by FDA.
Status:
US Approved OTC
Source:
21 CFR 347.10(a) skin protectant allantoin
Source URL:
First approved in 1961
Source:
ALLANTOMIDE ALLANTOIN by NATIONAL DRUG
Source URL:
Class (Stereo):
CHEMICAL (EPIMERIC)
Targets:
The aluminum salt of Allantoin, Alcloxa combines the astringent and anti-microbial properties of aluminum with the anti-irritant, soothing and healing properties of Allantoin. Alcloxa is particularly suited for use in anti-perspirants, acne treatments and foot care products. Alcloxa is a compound that combine the properties of aluminum salts with the properties of allantion. The allantion component ehhances the action of the aluminum salts and serves to overcome irritations experienced by many individuals who may be sensitive to the use of aluminum alts. The aluminum component reduces sweat by causing the sweat gland ducts swell. Alcloxa also add to the antiperspirant properties the deodorant effect because of its bacteriostatic action. It showed bacteriostatic properties at concentrations of 0.2% particularly against Gram bectaria (B. subtilis, S. aureus, P. vulgaris, Pityrosporum ovale). This is ascribable to two different mechanisms: first bacterial growth is retarded due to a decrease in the amount of water present, second aluminum salt have itself an antimicrobial action. In baby products is indicated for its healing reparative action, in the treatment of diaper rash. Also is approved in haemorrhoidal product for its soothing and keratolytic action. In oral care products Alcloxa is useful for its astringent antibacterial properties. It is very indicated in formulations for sensitive teeth, periodontal and gum diseases (like gingivitis, irritable and bleeding gums). Use levels: 0.1-1%. − In antiacne products the slightly astringent effect promotes healing of pustules and acne lesions. It reduces the extension of infected skin eruptions, healing them and developing a soothing action. May be used alone or also in combinations with other antimicrobial agents in order to fight acne more effectively. Use levels: 0.5-2.0%.
Status:
US Approved OTC
Source:
21 CFR 355.10(b)(1) anticaries:dentifrices sodium monolfuorophosphate (gel or paste)
Source URL:
First approved in 1953
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Monofluorophosphate (MFP) is an anion, which is a phosphate group with one oxygen atom substituted with a fluorine atom. Sodium Monofluorophosphate is intended to be used by both petitioners in food supplements as a source of fluoride in the forms of multi-vitamin, multi-mineral supplements, solid tablets or tablets dispersible in liquid. The toxic effects of Monofluorophosphate are attributable to the fluoride ion released by the in vivo hydrolysis of the parent compound. The Monofluorophosphate ion appears to play no role. The acute toxicity of Monofluorophosphate is somewhat less than that of NaF, due to the lesser availability of fluoride in the short term from Monofluorophosphate. In the long term, Monofluorophosphate produces virtually the same picture of renal effects and skeletal storage of fluoride as does NaF. Sodium Monofluorophosphate dissociates into sodium and Monofluorophosphate ions in the intestinal tract, the latter being absorbed mainly in the upper small intestine.
Status:
US Approved OTC
Source:
21 CFR 348.10(a)(2) external analgesic:male genital desensitizer lidocaine
Source URL:
First approved in 1948
Source:
NDA006488
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Lidocaine is a local anesthetic and cardiac depressant used to numb tissue in a specific area and for management of cardiac arrhythmias, particularly those of ventricular origins, such as occur with acute myocardial infarction. Lidocaine alters signal conduction in neurons by blocking the fast voltage-gated Na+ channels in the neuronal cell membrane responsible for signal propagation. With sufficient blockage, the membrane of the postsynaptic neuron will not depolarize and will thus fail to transmit an action potential. This creates the anesthetic effect by not merely preventing pain signals from propagating to the brain, but by stopping them before they begin. Careful titration allows for a high degree of selectivity in the blockage of sensory neurons, whereas higher concentrations also affect other modalities of neuron signaling. Lidocaine exerts an antiarrhythmic effect by increasing the electrical stimulation threshold of the ventricle during diastole. In usual therapeutic doses, lidocaine hydrochloride produces no change in myocardial contractility, in systemic arterial pressure, or an absolute refractory period. The efficacy profile of lidocaine as a local anesthetic is characterized by a rapid onset of action and intermediate duration of efficacy. Therefore, lidocaine is suitable for infiltration, block, and surface anesthesia. Longer-acting substances such as bupivacaine are sometimes given preference for spinal and epidural anesthesias; lidocaine, though, has the advantage of a rapid onset of action. Lidocaine is also the most important class-1b antiarrhythmic drug; it is used intravenously for the treatment of ventricular arrhythmias (for acute myocardial infarction, digoxin poisoning, cardioversion, or cardiac catheterization) if amiodarone is not available or contraindicated. Lidocaine should be given for this indication after defibrillation, CPR, and vasopressors have been initiated. A routine preventative dose is no longer recommended after a myocardial infarction as the overall benefit is not convincing. Inhaled lidocaine can be used as a cough suppressor acting peripherally to reduce the cough reflex. This application can be implemented as a safety and comfort measure for patients who have to be intubated, as it reduces the incidence of coughing and any tracheal damage it might cause when emerging from anesthesia. Adverse drug reactions (ADRs) are rare when lidocaine is used as a local anesthetic and is administered correctly. Most ADRs associated with lidocaine for anesthesia relate to administration technique (resulting in systemic exposure) or pharmacological effects of anesthesia, and allergic reactions only rarely occur. Systemic exposure to excessive quantities of lidocaine mainly result in a central nervous system (CNS) and cardiovascular effects – CNS effects usually occur at lower blood plasma concentrations and additional cardiovascular effects present at higher concentrations, though cardiovascular collapse may also occur with low concentrations.
Status:
US Approved OTC
Source:
21 CFR 333.210(f) antifungal undecylenic acid
Source URL:
First approved in 1945
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Undecylenic acid is unsaturated fatty acid, which naturally occurs in sweat, and is commercially produced by the vacuum distillation of castor bean oil. It is recognized as GRASE by FDA, and is marketed over the counter to treat skin infections and to relieve itching. Undecylenic acid acts by inhibition of morphogenesis from yeast to hyphae forms.
Status:
US Approved OTC
Source:
21 CFR 333.210(f) antifungal undecylenic acid
Source URL:
First approved in 1945
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Undecylenic acid is unsaturated fatty acid, which naturally occurs in sweat, and is commercially produced by the vacuum distillation of castor bean oil. It is recognized as GRASE by FDA, and is marketed over the counter to treat skin infections and to relieve itching. Undecylenic acid acts by inhibition of morphogenesis from yeast to hyphae forms.
Status:
US Approved OTC
Source:
21 CFR 331.11(e) antacid:citrate-containing citrate (containing active ingredients: citrate ion, as citric acid or salt)
Source URL:
First marketed in 1921
Class (Stereo):
CHEMICAL (RACEMIC)
Targets:
Conditions:
Potassium citrate is indicated for the management of renal tubular acidosis with calcium stones, hypocitraturic calcium oxalate nephrolithiasis of any etiology, uric acid lithiasis with or without calcium stones. WhenPotassium citrate is given orally, the metabolism of absorbed citrate produces an alkaline load. The induced alkaline load in turn increases urinary pH and raises urinary citrate by augmenting citrate clearance without measurably altering ultrafilterable serum citrate. Thus, potassium citrate therapy appears to increase urinary citrate principally by modifying the renal handling of citrate, rather than by increasing the filtered load of citrate. Potassium citrate is used as a food additive (E 332) to regulate acidity.
Status:
US Approved OTC
Source:
21 CFR 355.10(a)(2) anticaries:dentifrices sodium fluoride powder
Source URL:
First marketed in 1921
Source:
Calcium Chloride U.S.P.
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Olaflur (amine fluoride 297, trade name elmex gel) is a fluoride-containing substance that is an ingredient of toothpastes and solutions for the prevention of dental caries. Especially in combination with dectaflur, it is also used in the form of gels for the treatment of early stages of caries, sensitive teeth, and by dentists for the refluoridation of damaged tooth enamel. Olaflur is a salt consisting of an alkyl ammonium cation and fluoride as the counterion. With a long lipophilic hydrocarbon chain, the cation has surfactant properties. It forms a film layer on the surface of teeth, which facilitates incorporation of fluoride into the enamel. The top layers of the enamel's primary mineral, hydroxylapatite, are converted into the more robust fluorapatite. The fluoridation reaches only a depth of a few nanometres, which has raised doubts whether the mechanism really relies on the formation of fluorapatite.
Status:
US Approved OTC
Source:
21 CFR 331.11(m) antacid:tartrate-containing tartrate (acid or salt)
Source URL:
First marketed in 1921
Class (Stereo):
CHEMICAL (RACEMIC)
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.