U.S. Department of Health & Human Services Divider Arrow National Institutes of Health Divider Arrow NCATS

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Showing 101 - 110 of 158 results

Status:
US Previously Marketed
Source:
21 CFR 310.545(a)(18)(ii) skin protectant:astringent oxyquinoline sulfate
Source URL:
First approved in 1964
Source:
UDDER BALM by H. W. Naylor Company Inc.
Source URL:

Class (Stereo):
CHEMICAL (ACHIRAL)

Conditions:

In cosmetics and personal care products, Benzoxiquine has been reported to be used in the formulation of hair tonics, dressings, and other hair grooming aids. Benzoxiquine is described as a biocide for use in cosmetic products. It is currently reported to be used in only one product. In a separate finding, the Food and Drug Administration determined that Benzoxiquine is not generally recognized as safe and effective in over-the-counter topical antifungal drug products. The only data available on the toxicity of Benzoxiquine indicates that it is mutagenic in the Ames test without metabolic activation. Because of the lack of data, the safety of Benzoxiquine could not be substantiated. The data needed to make a safety assessment include purity/impurities, ultraviolet absorption (if there is absorption, then photosensitization data will be needed), 28-day dermal toxicity, dermal teratogenicity, ocular irritation (if already available only), dermal irritation and sensitization, and two different genotoxicity studies (one using a mammalian system). If the latter data are positive, dermal carcinogenesis data using the methods of the National Toxicology Program will be needed. It cannot be concluded that Benzoxiquine is safe for use in cosmetic products until these safety data have been obtained and evaluated.
Denatonium, usually available as denatonium benzoate (trade names Bitrex) is the most bitter chemical compound known, with bitterness thresholds of 0.05 ppm for the benzoate and 0.01 ppm for the saccharide. Scientists at Macfarlan Smith, Ltd. of Edinburgh, Scotland discovered Bitrex during research on derivatives of the anesthetic lidocaine. The extremely bitter taste proved effective in reducing ingestion by humans and animals. Denatonium is commonly included in placebo medications used in clinical trials to match the bitter taste of certain medications. Denatonium activates bitter taste receptor, mainly, TAS2R4, TAS2R8, TAS2R10, TAS2R13 on many cell types and plays important roles in chemical release, ciliary beating and smooth muscle relaxation through intracellular Ca(2+)-dependent pathways.
Status:
US Previously Marketed
Source:
21 CFR 310.545(a)(18)(iv) skin protectant:fever blister/cold sore trolamine
Source URL:

Class (Stereo):
CHEMICAL (ACHIRAL)


Trolamine, an organic compound, is the salt formed between triethanolamine and salicylic acid. It is widely used as a topical analgesic. 10% trolamine salicylate medical products sold over-the-counter such as are creams for temporarily relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, lumbago, neuralgia, strains, bruises, and sprains. The FDA approved in 1958 otic solution drops containing triethanolamine polypeptide used in the ear to break down and loosen earwax was discontinued. Trolamine can enhance skin healing by recruiting macrophages and modifying the concentrations of various immunomodulators. Trolamine (Biafine; Genmedix Ltd, France) is commonly prescribed at the beginning of radiotherapy for preventing acute radiation-induced skin toxicity in China. Biafine has been studied in radiodermatitis and Phase 2 clinical trial has been initiated in 2016 by Sun Yat-sen University to establish the efficacy of trolamine (Biafine) for the management of radiation dermatitis in patients with nasopharyngeal carcinoma receiving IMRT.
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:
Possibly Marketed Outside US
Source:
Calming Days Vegan Sunscreen by Merci Co.
(2022)
Source URL:
First approved in 2022
Source:
SUN PROJECT SKIN-RELIEF SUNCREAM by THANK YOU FARMER CO., LTD.
Source URL:

Class (Stereo):
CHEMICAL (MIXED)

Iscotrizinol is a triazine-based organic compound that readily absorbs UVA and UVB radiation with a peak protection at 310 nm. Iscotrizinol has an excellent photostability, it preserves 90% of its effectiveness after 63 hours. Iscotrizinol is commonly found in sunscreen and other sun care products in Europe and Japan but is not approved by the FDA for marketing in the US.
Status:
Possibly Marketed Outside US
Source:
Kiehls Ultra Light Daily UV Defense CC SPF 50 Anti Pollution by L'Oreal USA Products Inc
Source URL:

Class (Stereo):
CHEMICAL (ACHIRAL)

Diethylamino hydroxybenzoyl hexyl benzoate (DHHB) is an organic UV filter with high absorption in the UV-A range that minimizes the overexposure of human skin to ultraviolet radiation that may lead to acute and chronic photodamage. In in vitro studies, DHHB was not shown to be mutagenic, clastogenic, or phototoxic. DHHB was approved in Europe in 2005, is also marketed in the U.S., South America, Mexico, Japan and Taiwan, and is used in concentrations up to 10% in sunscreen products, either alone or in combination with other UV absorbers. Only a minor amount of diethylamino hydroxybenzoyl hexyl benzoate will undergo percutaneous absorption and most will remain in the upper layers of the skin. Fluorescence spectroscopy showed that DHHB and avobenzone (another chemical sunscreen ingredient) interact by a static quenching mechanism and DHHB did not affect the avobenzone excited state lifetime.
Alprenolol is a beta adrenoreceptor blocking agent and 5HT1A antagonist, developed by AstraZeneca and now available as generic drug. It is used for treatment of hypertension, angina pectoris due to coronary atherosclerosis and acute myocardial infarction.

Showing 101 - 110 of 158 results