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Status:
US Approved OTC
Source:
21 CFR 346.16(c) anorectal:analgesic, anesthetic, antipruritic menthol
Source URL:
First marketed in 1921
Class:
MIXTURE
Targets:
Conditions:
Menthol, (+)- is a fragrance ingredient used in decorative cosmetics, fine fragrances, shampoos, toilet soaps and other toiletries as well as in non-cosmetic products such as household cleaners and detergents. Recent investigations have provided evidence for menthol to increase cough thresholds. Racementhol is used as a topical analgesic.
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:
Precipitated Calcium Phosphate N.F.
Source URL:
Class:
MIXTURE
Conditions:
Anhydrous dibasic calcium phosphate is a calcium salt of phosphoric acid. It is used as a diluent in pharmaceutical industry, in some toothpastes as a polishing agent. Calcium phosphate is generally recognized as safe by FDA. Dibasic calcium phosphate is ised as a supplement to treat conditions associated with calcium deficit, such as bone loss (osteoporosis), weak bones (osteomalacia/rickets), decreased activity of the parathyroid gland (hypoparathyroidism), and a certain muscle disease (latent tetany)
Status:
US Approved OTC
Source:
21 CFR 333.110(a) first aid antibiotic:ointment bacitracin
Source URL:
First marketed in 1921
Class:
MIXTURE
Targets:
Conditions:
Bacitracin is a polypeptide antibiotic produced by Bacillus subtilis and Bacillus licheniformis. Bacitracin in combination with neomycin and polymyxin B is indicated for the treatment of many bacterial diseases. The antibacterial properties of bacitracin are mediated by its binding to C55-isoprenyl pyrophosphate, resulting in inhibition of cell wall biosynthesis.
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:
Precipitated Calcium Phosphate N.F.
Source URL:
Class:
MIXTURE
Conditions:
Anhydrous dibasic calcium phosphate is a calcium salt of phosphoric acid. It is used as a diluent in pharmaceutical industry, in some toothpastes as a polishing agent. Calcium phosphate is generally recognized as safe by FDA. Dibasic calcium phosphate is ised as a supplement to treat conditions associated with calcium deficit, such as bone loss (osteoporosis), weak bones (osteomalacia/rickets), decreased activity of the parathyroid gland (hypoparathyroidism), and a certain muscle disease (latent tetany)
Status:
US Approved OTC
Source:
21 CFR 347.10(c) skin protectant calamine
Source URL:
First marketed in 1921
Source:
Saccharated Ferric Oxide N.F.
Source URL:
Class:
MIXTURE
Conditions:
Ferric chloride is a compound used as a food additive, a haemostatic or treatment for hypochromic anaemia. Ferric chloride induced vascular injury is a widely used model of occlusive thrombosis that reports platelet activation and aggregation in the context of an aseptic closed vascular system. Iron i.v. ferric chloride (960 mg) has being shown to be effective in correcting anaemia in HD patients with iron deficiency.
Status:
US Approved OTC
Source:
21 CFR 331.11(g)(7) antacid:magnesium-containing magnesium oxide
Source URL:
First marketed in 1921
Source:
Magnesium Carbonate U.S.P.
Source URL:
Class:
MIXTURE
Targets:
Conditions:
Struvite, a crystalline substance first identified in the 18th century, is composed of magnesium ammonium
phosphate. Struvite urinary stones are also known as ‘infection stones’, and account for 15%-20% of all urinary stones. Bacterial urease, usually from a Proteus species, is responsible for the chemical changes in urine which result in struvite formation.
Status:
US Approved OTC
Source:
21 CFR 333.210(d) antifungal povidone-iodine
Source URL:
First marketed in 1921
Class:
MIXTURE
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 331.11(g)(7) antacid:magnesium-containing magnesium oxide
Source URL:
First marketed in 1921
Source:
Magnesium Carbonate U.S.P.
Source URL:
Class:
MIXTURE
Targets:
Conditions:
Struvite, a crystalline substance first identified in the 18th century, is composed of magnesium ammonium
phosphate. Struvite urinary stones are also known as ‘infection stones’, and account for 15%-20% of all urinary stones. Bacterial urease, usually from a Proteus species, is responsible for the chemical changes in urine which result in struvite formation.
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:
Precipitated Calcium Phosphate N.F.
Source URL:
Class:
MIXTURE
Conditions:
Anhydrous dibasic calcium phosphate is a calcium salt of phosphoric acid. It is used as a diluent in pharmaceutical industry, in some toothpastes as a polishing agent. Calcium phosphate is generally recognized as safe by FDA. Dibasic calcium phosphate is ised as a supplement to treat conditions associated with calcium deficit, such as bone loss (osteoporosis), weak bones (osteomalacia/rickets), decreased activity of the parathyroid gland (hypoparathyroidism), and a certain muscle disease (latent tetany)
Class:
MIXTURE
Targets:
Ramoplanin is a glycolipodepsipeptide antibiotic obtained from the fermentation of Actinoplanes sp. ATCC 33076 that exhibits activity against clinically important multi-drug-resistant, Gram-positive pathogens including vancomycin-resistant Enterococcus (VRE), methicillin-resistant Staphylococcus aureus (MRSA), and vancomycin-intermediate resistant Clostridium difficile. Ramoplanin was first isolated as a complex of three closely related components A1, A2, and A3. Preclinical studies have also demonstrated that ramoplanin exerts a rapid bactericidal effect on S. aureus biofilms and that a clinical vancomycin-resistant S. aureus strain containing the vanA gene was susceptible to ramoplanin. Ramoplanin blocks bacterial cell wall biosynthesis by interfering with peptidoglycan production. Ramoplanin inhibits the N-acetylglucosaminyltransferase-catalysed conversion of lipid intermediate I to lipid intermediate II, a step that occurs before the transglycosylation and transpeptidation reactions. Ramoplanin’s mechanism of action is distinct from that of glycopeptides. Unlike glycopeptides, ramoplanin does not complex with the D-Ala–D-Ala sequence of cell wall precursors. Ramoplanin is being developed for the targeted prophylaxis of recently treated patients with C. difficile infection (CDI) at high risk for infection relapse. Twelve Phase I studies, two Phase II studies (one in CDI and one in VRE) as well as one Phase III study (in VRE) have been conducted