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Search results for lactic root_codes_comments in Code Comments (approximate match)
Status:
US Approved Rx
(2016)
Source:
ANDA205880
(2016)
Source URL:
First marketed in 1921
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Benzoic acid is a natural ingredient occurring in many foodstuffs and in plant extracts. Benzoic acid, its salts and esters are used as preservatives in cosmetic products, with a maximum concentration of 0.5 %. Benzoic acid and sodium benzoate are on the FDA list of substances that are generally recognized as safe (GRAS). Both may be used as antimicrobial agents, flavouring agents and as adjuvants with a current maximum level of 0.1% in food. Benzoic acid is a constituent of Whitfield Ointment, which is used for the treatment of fungal skin diseases such as tinea, ringworm, and athlete's foot. Adverse effect of Whitfield Ointment: occasionally, a localized mild inflammatory response occurs.
Status:
US Approved Rx
(2003)
Source:
NDA021388
(2003)
Source URL:
First marketed in 1921
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Talcum powder is made from talc, a mineral made up mainly of the elements magnesium, silicon, and oxygen. As a powder, it absorbs moisture well and helps cut down on friction, making it useful for keeping skin dry and helping to prevent rashes. It is widely used in cosmetic products such as baby powder and adult body and facial powders, as well as in a number of other consumer products. The therapeutic action of talc instilled into the pleural cavity is believed to result from induction of an inflammatory reaction. This reaction promotes adherence of the visceral and parietal pleura, obliterating the pleural space and preventing reaccumulation of pleural fluid. Sterile Talc Powder, administered intrapleurally via chest tube, is indicated as a sclerosing agent to decrease the recurrence of malignant pleural effusions in symptomatic patients. The most often reported adverse experiences to intrapleurally-administered talc were fever and pain.
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 Rx
(1976)
Source:
NDA017641
(1976)
Source URL:
First marketed in 1921
Source:
Elixir of Iron Lactate N.F.
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Targets:
Conditions:
Sodium lactate is primarily indicated as a source of bicarbonate for prevention or control of mild to moderate metabolic acidosis in patients
with restricted oral intake whose oxidative processes are not seriously impaired. Sodium Lactate is most commonly associated with an E number of “E325” Sodium Lactate blends are commonly used in meat and poultry products to extend shelf life and increase food safety. They have a broad antimicrobial action and are effective at inhibiting most spoilage and pathogenic bacteria. In addition sodium lactate is used in cosmetics as a humectant, providing moisture.
Status:
US Approved Rx
(2021)
Source:
ANDA214864
(2021)
Source URL:
First marketed in 1880
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Betaine is a methyl derivative of glycine first isolated from the juice of sugar beets. Betaine is found in many common foods, but concentrated significantly in beets, spinach, wheat foods, and shellfish. In addition, betaine can be synthesized within the human body. Betaine participates in the methionine cycle, which produces vital biomolecules including proteins, hormones, phospholipids, polyamines, and nutrients. Betaine is used as a dietary supplement and has a beneficial effect on the human health. In the USA, FDA approved a betaine-containing drug Cystadane for the treatment of homocystinuria. The drug acts as a methyl group donor in the remethylation of homocysteine to methionine.
Status:
US Approved Rx
(2017)
Source:
NDA209963
(2017)
Source URL:
First marketed in 1860
Class (Stereo):
CHEMICAL (ABSOLUTE)
Conditions:
Cocaine is an alkaloid ester extracted from the leaves of plants including coca. Cocaine is a local anesthetic and vasoconstrictor and is clinically used for that purpose, particularly in the eye, ear, nose, and throat. It also has powerful central nervous system effects similar to the amphetamines and is a drug of abuse. Cocaine, like amphetamines, acts by multiple mechanisms on brain catecholaminergic neurons; the mechanism of its reinforcing effects is thought to involve inhibition of dopamine uptake. Cocaine is addictive due to its effect on the reward pathway in the brain. After a short period of use, there is a high risk that dependence will occur. Its use also increases the risk of stroke, myocardial infarction, lung problems in those who smoke it, blood infections, and sudden cardiac death. Cocaine sold on the street is commonly mixed with local anesthetics, cornstarch, quinine, or sugar which can result in additional toxicity. Following repeated doses, a person may have decreased the ability to feel pleasure and be very physically tired. Cocaine acts by inhibiting the reuptake of serotonin, norepinephrine, and dopamine. This results in greater concentrations of these three neurotransmitters in the brain. It can easily cross the blood-brain barrier and may lead to the breakdown of the barrier.
Status:
US Approved OTC
Source:
21 CFR 333.310(a) acne benzoyl peroxide
Source URL:
First approved in 1984
Source:
NDA050557
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Benzoyl peroxide (BPO) is an organic compound in the peroxide family. It consists of two benzoyl groups bridged by a peroxide link. It is one of the most important organic peroxides in terms of applications and the scale of its production. Benzoyl peroxide is used as an acne treatment, for bleaching hair and teeth. Adverse reactions are: dryness and urticarial reaction, contact dermatitis, application site burning, application site irritation and skin irritation.
Status:
US Approved OTC
Source:
21 CFR 349.12(d)(5) ophthalmic:demulcents propylene glycol
Source URL:
First approved in 1961
Source:
VOSOL PROPYLENE GLYCOL by WAMPOLE LABS
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Conditions:
PROPYLENE GLYCOL is a component of SYSTANE® Lubricant. It is used for the temporary relief of burning and irritation due to dryness of the eye.
Status:
US Approved OTC
Source:
21 CFR 332.10 antiflatulent simethicone
Source URL:
First approved in 1952
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Silicon dioxide (silica) is most commonly found in nature as quartz, as well as in various living organisms. Silicon dioxide one of the most complex and most abundant families of materials, existing both as several minerals and being produced synthetically. In food and pharmaceutical industry silica is a common additive, where it is used primarily as a flow in powdered foods, or to adsorb water in hygroscopic application. In pharmaceutical products, silica aids powder flow when tablets are formed.
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.