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Restrict the search for
glycerol phenylbutyrate
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Glyceryl 1,2-dilaurate is the fatty acid diester of glycerol. Glyceryl diesters, on a whole, are FDA and CIR approved and are given the GRAS rating. It is used as an emollient (skin conditioning agent) in cosmetics for increasing the "body" and viscosity of emulsions and improving the elegance of low-cost formulations. In addition, it may be used for the preparation of nanolipid carriers for drug delivery.
Status:
US Previously Marketed
Source:
21 CFR 310.545(a)(18)(i)(B) skin protectant:w/ sales less than $25,000 glyceryl stearate
Source URL:
First approved in 1971
Source:
ANDA090256
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Conditions:
Glyceryl 1-stearate (Glycerol monostearate), commonly known as GMS, is an organic molecule used as an emulsifier. GMS is a white, odorless, and sweet-tasting flaky powder that is hygroscopic. It is a glycerol ester of stearicacid. It occurs naturally in the body as a product of the breakdown of fats by pancreatic lipase, and is also found in fatty foods. GMS is a food additive used as a thickening, emulsifying, anti-caking, and preservative agent; an emulsifying agent for oils, waxes, and solvents; a protective coating for hygroscopic powders; a solidifier and control release agent in pharmaceuticals; and a resin lubricant. It is also used in cosmetics and hair care products. Used in antiperspirants and deodorants, baby care, body care, facial care, sun care, conditioners, facial make-up, creams and lotions-skin care, sprayable emulsions, feet, hands and nails, self-tanning, nail grooming and color cosmetics. GMS is largely used in baking preparations to add "body" to the food. It is responsible for giving ice cream and whipped cream its smooth texture. It is sometimes used as an anti-staling agent in bread. Glycerol 1-stearate is affirmed by FDA as GRAS.
Status:
First approved in 1957
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Triacetin, also known as Glyceryl Triacetate, is a cosmetic biocide, plasticizer, and solvent in cosmetic formulations, at concentrations ranging from 0.8% to 4.0%. It is a commonly used carrier for flavors and fragrances. Triacetin was affirmed as a generally recognized as safe (GRAS) human food ingredient by the Food and Drug Administration (FDA). It is used as an inactive ingredient additive in some drug formulations. It has been used as a plasticizer in the tests of acrylic polymer films for drug delivery. Triacetin is not toxic to animals. However, in one study, it caused erythema, slight edema, alopecia, and desquamation, and did cause some irritation in rabbit eyes. Concentration of triacetin in consumer products is in the range of about 0.005-2 % for cosmetics, and has been reported to be as high as 15-33 % for one specific antifungal drug.
Status:
US Previously Marketed
Source:
Merphenyl Nitrate by Hamilton
(1937)
Source URL:
First marketed in 1921
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Phenylmercuric nitrate is classified as an antimicrobial preservative. It is bactericidal against many Gram-positive and Gram-negative species. It is used as antimicrobial preservative mainly in ophthalmic preparations. Patients who used eye drops containing the preservative, phenylmercuric nitrate for from 3 to 15 years, developed a brownish pigmentation of the anterior capsule of the pupillary area. Special studies, including electron microprobe analysis and neutron activation analysis established the presence of mercury in a lens with mercurialentis. Phenylmercuric nitrate is also an effective spermicide, although its use in vaginal contraceptives is no longer recommended.
Status:
US Previously Marketed
Source:
BENZYL BENZOATE by LANNETT
(1976)
Source URL:
First marketed in 1921
Source:
Benzyl benzoate by Merck
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Benzyl benzoate is an organic compound with the formula C6H5CH2O2CC6H5. It is the ester of benzyl alcohol and benzoic acid. It forms either a viscous liquid or solid flakes and has a weak, sweet-balsamic odor. It occurs in a number of blossoms (e. g. tuberose, hyacinth) and is a component of Balsam of Peru and Tolu balsam. It is on the World Health Organization's List of Essential Medicines, a list of the most important medication needed in a basic health system. Benzyl benzoate is one of the older preparations used to treat scabies. Scabies is a skin infection caused by the mite sarcoptes scabiei. It is characterised by severe itching (particularly at night), red spots, and may lead to a secondary infection. Benzyl benzoate is lethal to this mite and so is useful in the treatment of scabies. It is also used to treat lice infestation of the head and body. Benzyl benzoate is not the treatment of choice for scabies due to its irritant properties. Benzyl benzoate exerts toxic effects on the nervous system of the parasite, resulting in its death. It is also toxic to mite ova, though its exact mechanism of action is unknown. In vitro, benzyl benzoate has been found to kill the Sarcoptes mite within 5 minutes.
Status:
US Previously Marketed
Source:
OTOMIDE CHLOROBUTANOL by WHITE
(1961)
Source URL:
First marketed in 1911
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Chlorobutanol, or trichloro-2-methyl-2-propanol, is an analgesic and sedative hypnotic in man, and an experimental general anesthetic. It has antibacterial and antifungal properties. It is also used chemical preservative for parenteral drugs. It was found, that chlorobutanol inhibited mammalian Nav 1.2 channels at concentrations less than those used to preserve parenteral solutions. Its mechanism of inhibiting Na channels differs from that of local anesthetics in that it does not show use dependent or state dependent inhibition.
Status:
US Previously Marketed
Source:
21 CFR 310.545(a)(29) sunscreen glyceryl aminobenzoate (lisadimate, glyceryl PABA)
Source URL:
Class (Stereo):
CHEMICAL (RACEMIC)
Conditions:
Lisadimate (glyceryl PABA), a substituted aminobenzoate, is a sunscreen with actions similar to those of aminobenzoic acid. It is effective against UVB light. Glyceryl PABA (Escalol 106), present in many popular sunscreens, is a common sensitizer which invariably cross-reacts with benzocaine; it is present in over 400 over-the-counter products. Glyceryl PABA does not appear to cross-react with the sunscreening agents amyl (Escalol 506) and octyl (Escalol 507) dimethyl PABA. Glyceryl PABA, may, on occasion, cross-react with para-aminobenzoic acid (PABA), paraphenylenediamine, aniline, and sulfa drugs. Ironically, the sunscreening agent glyceryl PABA may, itself, act as a photosensitizing agent.
