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Status:
Possibly Marketed Outside US
First approved in 1978
Source:
Dairyland Brand Teat Dip by Stearns Packaging Corporation
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
DIDECYLDIMONIUM (as a salt, didecyldimethylammonium chloride (DDAC)) is used in many types of biocidal products including tableware, carpets, humidifiers, and swimming pools. It shows a broad spectrum of activity against both gram-positive and gram-negative bacteria and is also effective on fungi and viruses, including those that are enveloped.
Status:
Possibly Marketed Outside US
First approved in 1978
Source:
NDA020963
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Benzododecinium, a quaternary ammonium compound, is an antiseptic agent and disinfectant. Benzododecinium is used as preservative in different pharmaceutical formulations. Thus, the dispenser of Timoptol-LA, used for the treatment of patients with ocular hypertension, contains benzododecinium bromide as a preservative. It is used as preservative and the corneal permeability enhancer in formulation. Benzododecinium is effective against gram-positive microbes.
Status:
Possibly Marketed Outside US
Source:
NCT02104596: Phase 4 Interventional Unknown status Knee Osteoarthritis
(2014)
Source URL:
First approved in 1978
Source:
60-Second Fluoride Pina Colada by Patterson Dental Supply Inc
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Xylitol is a naturally occurring alcohol found in most plant material, including many fruits and vegetables. Xylitol is widely used as a sugar substitute and in "sugar-free" chewing gums, mints, and other candies. As a medicine, xylitol is used to prevent middle ear infections (otitis media) in young children, and as a sugar substitute for people with diabetes. Xylitol is added to some chewing gums and other oral care products to prevent tooth decay and dry mouth.
Status:
Possibly Marketed Outside US
Source:
21 CFR 333A
(2018)
Source URL:
First approved in 1978
Source:
K-PhosNo. 2 by Beach Products, Inc.
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Status:
Possibly Marketed Outside US
Source:
Dairyland Brand Teat Dip by Stearns Packaging Corporation
(1978)
Source URL:
First approved in 1978
Source:
Dairyland Brand Teat Dip by Stearns Packaging Corporation
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Rhodamine B is a fluorescent dye whose quantum yield is strongly dependent on temperature in the range of 0°C to 100°C, making it ideal for liquid based systems. It is a cell-permeant fluorogenic dye most often used as a conjugate to antibodies and proteins for fluorescence detection in microscopy. Rhodamine B is widely used in industrial purposes, such as printing and dyeing in textile, paper, paints, leathers etc. Rhodamine B was tested for use as a biomarker in oral rabies vaccines for raccoons, to identify animals that have eaten a vaccine bait. It has also been used as an anterograde and retrograde tracer in neurons and in nanoparticles to detect apoptosis.
Status:
Possibly Marketed Outside US
First approved in 1977
Source:
NADA128620
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Fenbendazole (FBZ) is a broad-spectrum benzimidazole antiparasitic drug currently approved for use in numerous animal species, including rodents. Although nematodes, and in particular pinworms, are the main endoparasites of concern in laboratory rodents, FBZ also is indicated for use in other animal species against a wide spectrum of nematodes, tapeworms, flukes, and protozoa (Giardia duodenalis, Encephalitozoon intestinalis). The molecular mode of fenbendazole action consists in binding of beta-tubulin monomer prior to dimerisation with alfa-tubulin which blocks subsequent microtubule formation. These microtubules are important organelles involved in the motility, the division and the secretion processes of cells in all living organisms. In the worms the blocking of microtubules perturbs the uptake of glucose, which eventually empties the glycogen reserves. This blocks the whole energy management mechanism of the worms that are paralyzed and die or are expelled. FBZ have a greater binding to nematode as compared to mammalian tubulin at 37°C. The oral LD50 of p-OH fenbendazole was >10 000 mg/kg b.w. in mice and rats.
Status:
Possibly Marketed Outside US
First approved in 1977
Source:
NDA021777
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Diethyl phthalate is a colourless liquid with a slight aromatic odour and low volatility. Diethyl phthalate is used as a plasticizer for
cellulose ester plastic films and sheets (photographic, blister packaging, and tape applications) and moulded and extruded articles (consumer articles such as toothbrushes, automotive components, tool handles, and toys). Diethyl phthalate was reported as an ingredient in 67 cosmetic formulations. Diethyl phthalate is used as a component in insecticide sprays and mosquito repellents. Diethyl phthalate is likely to undergo biodegradation in the environment. General population exposure in the USA, as estimated from urinary concentrations of the monoester, was estimated to be 12 µg/kg body weight per day (median value). Dermally applied diethyl phthalate penetrates the skin and can be widely distributed in the body, but it does not accumulate in tissue. Diethyl phthalate has irritant effects on the eyes, skin, and mucous membranes and can lead to central nervous system (CNS) effects in exposed workers. The exposure to diethyl phthalates (DEP), a parent compound of the monoethyl phthalate (MEP) metabolite, may be associated with increased risk of BC (Odds Ratio of 2.20, p value for trend, p<0.003).
Status:
Possibly Marketed Outside US
Source:
M032
(2017)
Source URL:
First approved in 1977
Source:
21 CFR 333C
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Lauramide DEA is a compound made from a saturated fatty acid called lauric acid and diethanolamine or DEA, an ingredient in some cosmetic products that functions as a wetting agent. Combinations of fatty acids and DEA like lauramide DEA are referred to as diethanolamides. The diethanolamide lauramide DEA is an ingredient in some personal care products including shampoo, hair coloring products, hand soap, bubble baths, bath gels and lotions. In cosmetic and personal care products, lauramide DEA enhances a product’s ability to form and maintain foam. It also increases the viscosity or thickness of products. This gives them a more substantial feel. Without a viscosity-enhancing agent, shampoos and other personal care products would be considered too “runny” by some. Viscosity increasing agents like lauramide DEA are often combined with surfactants to maximize the texture and performance of cosmetic and personal care products that foam like shampoo and bubble bath. Lauramide DEA also serves as an emulsion stabilizer that helps to keep water-soluble and oil-soluble ingredients together in a product. Diethanolamides like lauramide DEA are found in cosmetic and personal care products in concentrations of between 1 and 10%. At these concentrations, the Cosmetic Ingredient Review Expert Panel, a group of independent experts that looks at the safety of cosmetic ingredients, deems lauramide DEA to be safe. This assumes that lauramide DEA isn’t contamined with other ingredients called nitrosating agents. Nitrosating agents interact with lauramide DEA to form nitrosamines, chemicals linked with an increased risk of cancer. This can happen during the manufacture of a product or during storage. Such ingredients must be excluded from products that contain diethanolamides like lauramide DEA, although there are still concerns about contamination. Topically, lauramide DEA can cause mild skin irritation. There are also reports of contact dermatitis and allergic reactions in some people.
Status:
Possibly Marketed Outside US
Source:
21 CFR 347
(2012)
Source URL:
First approved in 1977
Source:
NDA017563
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Maltol is a naturally occurring organic compound isolated from pine needles, larch bark, the destructive distillates of various organic materials and the alkaline hydrolysis products of streptomycin. Because of caramel-butterscotch odor, and suggestive of fruity-strawberry aroma in dilute solutions, maltol is used as a food additive mainly in confectionary and bakery products. Maltol is considered safe by FDA according to existing data and granted GRAS status. Maltol chelates metal ions such as Fe3+, Al3+, and is reported to increase uptake of aluminum and iron in the body. Maltol was reported to have a neuroprotective effect on retinal ganglion cells under oxidative stress, and hepatoprotective effect on alcohol-induced liver oxidative injury.
Status:
Possibly Marketed Outside US
Source:
21 CFR 341
(2005)
Source URL:
First approved in 1976
Source:
ANDA084769
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)