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Search results for "PART 178 -- INDIRECT FOOD ADDITIVES in comments (approximate match)
Status:
Possibly Marketed Outside US
First approved in 1993
Source:
NDA020215
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Aluminum Stearate (C54H105AlO6) exists as white powder and is an aluminum salt of stearic acid. In the pharmaceutical industry, it is used as an anticaking agent; colorant; emulsion stabilizer; and viscosity increasing agent. According to the FDA, aluminum stearate is considered safe for general or specific, limited use in food. Aluminum stearate is not classifiable as a human carcinogen (cancer-causing agent).
Status:
Possibly Marketed Outside US
Source:
ANDA212342
(1979)
Source URL:
First approved in 1979
Source:
ANDA212342
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
Possibly Marketed Outside US
Source:
NCT01657032: Phase 4 Interventional Completed Diarrhea
(2010)
Source URL:
First approved in 1946
Source:
21 CFR 348
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Montmorillonite is a very soft phyllosilicate group of minerals that form when they precipitate from water solution as microscopic crystals, known as clay. Montmorillonite is a typical weathering of aluminosilicates and one of the main minerals in many soils. Montmorillonite is the main component of bentonite that found in many sedimentary rocks. Due to its high adsorption properties, montmorillonite is used in the oil, textile, paper, and soap industries as an active component of bleaching and cloth clay. Montmorillonite is used in the oil drilling industry as a component of drilling mud, making the mud slurry viscous, which helps in keeping the drill bit cool and removing drilled solids. It is also used as a soil additive to hold soil water in drought-prone soils, used in the construction of earthen dams and levees, and to prevent the leakage of fluids. It is also used as a component of foundry sand and as a desiccant to remove moisture from air and gases. Montmorillonite is effective as an adsorptive of heavy metals and has been used and eaten from ancient time till now. For external use, montmorillonite has been used to treat contact dermatitis and in the materials produced for orthopedics, traumatology, dentistry.
Status:
US Approved OTC
Source:
21 CFR 349.14(b)(4) ophthalmic:emollient petrolatum
Source URL:
First marketed in 1921
Class:
STRUCTURALLY DIVERSE
Status:
US Approved Rx
(2008)
Source:
NDA022009
(2008)
Source URL:
First approved in 1993
Source:
21 CFR 352
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Titanium dioxide, also known as titanium(IV) oxide or titania, is the naturally occurring oxide of titanium, chemical formula TiO
2. When used as a pigment, it is called titanium white, Pigment White 6 (PW6), or CI 77891. Generally it is sourced from ilmenite, rutile and anatase. It has a wide range of applications, from paint to sunscreen to food coloring. When used as a food coloring, it has E number E171. World production in 2014 exceeded 9 million metric tons. Titanium dioxide has excellent ultraviolet (UV) resistant qualities and acts as a UV absorbent. In the pharmaceutical industry, titanium dioxide is used in most sunscreens to block UVA and UVB rays, similar to zinc oxide. It is also commonly used as pigment for pharmaceutical products such as gelatin capsules, tablet coatings and syrups. In the cosmetics industry, it is used in toothpaste, lipsticks, creams, ointments and powders. It can be used as an opacifier to make pigments opaque. The FDA has approved the safety of titanium dioxide for use as a colorant in food, drugs and cosmetics, including sunscreens. However, controversy exists as to the safety of titanium dioxide nanoparticles used in the cosmetics industry, for example in sunscreens. Titanium and zinc oxides may be made into the nanoparticle size (0.2-100 nanometers) to reduce the white appearance when applied topically, but retain the UV blocking properties. Recent studies suggest titanium dioxide nanoparticles may be toxic, although further research is needed.
Status:
US Approved Rx
(2024)
Source:
ANDA218538
(2024)
Source URL:
First approved in 1986
Source:
NDA018961
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Chromium sulfate(III) hexahydrate or chromium sulphate, a trivalent compound of chromium that was investigated as a toxic compound. Experiments on rodent have shown chromium sulfate produced severe and widespread effects in the nasal cavity, larynx, lungs, and mediastinal lymph node. Effects were characterized by the accumulation of foreign material, infiltration of alveolar macrophages, septal cell hyperplasia, and granulomatous and chronic inflammation. Besides, chromium sulphate exerted a disadvantageous effect on the skeleton, as it decreases bone density and resistance.
Status:
US Approved OTC
Source:
21 CFR 346.18(a) anorectal:astringent calamine
Source URL:
First marketed in 1921
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
There is no available information related any biological and pharmaceutical application of ammonium tetrachlorozincate.
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)
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 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)
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 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)
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.