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Search results for "PART 184 -- DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE" in comments (approximate match)
Status:
US Approved Allergenic Extract
(1994)
Source:
BLA103738
(1994)
Source URL:
First approved in 1961
Source:
NDA012911
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Propylparaben is a bacteriostatic and fungistatic agent used as a preservative in cosmetic products, food and drugs. As a food additive, it has the E number E216. To increase the activity and reduce its dose propylparaben is used in a mixture with other parabens and in combination with other types of preservatives. Propylparaben is a chemical allergen capable of producing immunologically mediated hypersensitivity reactions. Chemically it is an ester of p-hydroxybenzoic acid.
Status:
US Previously Marketed
Source:
21 CFR 310.545(a)(22)(ii) antifungal:diaper rash methylparaben
Source URL:
First approved in 1987
Source:
NDA019527
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Methylparaben (E number E218) is preservative in the food, cosmetic, and pharmaceutical industries. It is completely absorbed through the skin or after ingestion and and it is hydrolyzed to para-hydroxybenzoic acid, and metabolites are rapidly excreted in the urine. Methylparaben is on the FDA generally regarded as safe list.
Status:
US Previously Marketed
Source:
SOLATENE by ROCHE
(1975)
Source URL:
First approved in 1964
Source:
UDDER BALM by H. W. Naylor Company Inc.
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Beta-carotene is found in many foods and is sold as a dietary supplement. Beta-carotene is a carotenoid, weak antioxidant; precursor of vitamin A, which is essential for vision and growth. Used to reduce the severity of photosensitivity reactions in patients with erythropoietic protoporphyria (EPP). Has been used in high-dose antioxidant supplements containing ascorbic acid and vitamin E with zinc in high-risk patients with age-related macular degeneration. Beta-carotene is also used to decrease asthma symptoms caused by exercise; to prevent certain cancers, heart disease, cataracts; and to treat AIDS, alcoholism, Alzheimer’s disease, depression, epilepsy, headache, heartburn, high blood pressure, infertility, Parkinson’s disease, rheumatoid arthritis, schizophrenia, and skin disorders including psoriasis and vitiligo.
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
First approved in 1949
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Inositol is a vitamin-like substance. It is found in many plants and animals. It is produced by the human body from glucose, it is not an essential nutrient. Inositol and some of its mono- and polyphosphates function as the basis for a number of signaling and secondary messenger molecules. Inositol is used for diabetic nerve pain, panic disorder, high cholesterol, insomnia, cancer, depression, schizophrenia, Alzheimer’s disease, attention deficit-hyperactivity disorder (ADHD), autism, promoting hair growth, a skin disorder called psoriasis, and treating side effects of medical treatment with lithium. Inositol is also used by mouth for treating conditions associated with polycystic ovary syndrome, including failure to ovulate; high blood pressure; high triglycerides; and high levels of testosterone. Inositol is possibly safe for most adults. It can cause nausea, tiredness, headache, and dizziness.
Status:
US Previously Marketed
First approved in 1942
Source:
BLA101138
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
OCTANOIC ACID (Caprylic acid) eight-carbon saturated fatty acid belongs to the class of mediumchain saturated fatty acids. OCTANOIC ACID found naturally in the milk of various mammals, and as a minor constituent of coconut oil and palm kernel oil. Caprylic acid is used commercially in the production of esters used in perfumery and also in the manufacture of dyes. Caprylic acid is an antimicrobial pesticide used as a food contact surface sanitizer in commercial food handling establishments on dairy equipment, food processing equipment, breweries, wineries, and beverage processing plants. It is also used as disinfectant in health care facilities, schools/colleges, animal care/veterinary facilities, industrial facilities, office buildings, recreational facilities, retail and wholesale establishments, livestock premises, restaurants, and hotels/motels. In addition, caprylic acid is used as an algaecide, bactericide, and fungicide in nurseries, greenhouses, garden centers, and interiorscapes on ornamentals. Products containing caprylic acid are formulated as soluble concentrate/liquids and ready-to-use liquids.
Status:
US Previously Marketed
Source:
LENIC WITH NIACIN LINOLEIC ACID by CROOKES-BARNES
(1961)
Source URL:
First marketed in 1921
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Linoleic acid is a naturally occurring omega-6 essential fatty acid, present in a variety of foods, including the oils. Linoleic acid is a precursor for arachidonic acid biosynthesis; on the first enzymatic step of the pathway involves delta-6-desaturase, which converts linoleic acid to gamma-lenolenic acid. Linoleic acid has beneficial effects on human skin and hair. Replacement of saturated fat with linoleic acid is advocated to improve serum lipoprotein profiles and reduce the risk of coronary artery disease. Linoleic acid was tested in clinical trilas as a possible remedy against multiple sclerosis.