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

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Showing 71 - 80 of 224 results

Status:
US Approved Allergenic Extract (1994)

Class (Stereo):
CHEMICAL (ACHIRAL)


Conditions:

Bronopol is used as a preservative in various cosmetic, pharmaceutical, toiletry and household preparations at concentrations of up to 0.1% (wt/vol) particularly because of its high activity against Gram-negative bacteria, especially Pseudomonas aeruginosa and other pseudomonad. Bronopol hydrolyzes within 3 h at 60 °C and pH 8, producing formaldehyde, nitrosamines, and other molecules. Although the parent compound (bronopol) is rather short-lived in the environment, its degradation products are toxic and more persistent. The protection against the bactericidal activity of bronopol afforded by catalase or superoxide dismutase suggests that the activity stems from the aerobic interaction and the generation of active oxygen species from oxygen diffusing into the suspensions during bronopol treatment. The acute oral LD50 was 307 mg/kg for rat males and 342 mg/kg for females. Bronopol is moderately toxic by the oral route. Results from an acute dermal toxicity study while inadequate, suggest bronopol is highly toxic by the dermal route.
Status:
US Approved Allergenic Extract (1994)
First approved in 1954
Source:
Sterosan by Geigy
Source URL:

Class (Stereo):
CHEMICAL (ACHIRAL)



Chlorquinaldol is a halogenated hydroxyquinoline with properties similar to those of clioquinol. It is mainly applied topically in infected skin conditions and in vaginal infections. The product is applied for local treatment of cortico-sensitive dermatosis with moderately manifested superinfection, acute and subacute eczema, dermatitis, pyodermia, intertrigo, infected wounds, dermatomycosis, pemphigus in newborn. Chlorquinaldol is also used as antiseptic, fungistat, or deodorant. Chlorquinaldol is not commercially available in the U.S. but is used in other countries principally as an amebicide for nonspecific diarrheas and gynecologic infections. It is known most commonly under the proprietary name of Sterosan. Other trade names include Cynotherax, Gyno-Sterosan, Saprosan, Siogeno, Siosteran, Slosteran and Steroxin.
Status:
US Previously Marketed
Source:
21 CFR 310.545(a)(27)(viii) antimicrobial:personnel hand wash triclocarban
Source URL:

Class (Stereo):
CHEMICAL (ACHIRAL)


Triclocarban is a triclosan analogue with an antibmicrobial property. It has been used in a wide range of personal cleansing products including deodorant and bar soaps, deodorants, detergents, cleansing lotions, and wipes. In US triclocarban was approved for marketing of over-the-counter (OTC) consumer antiseptic wash products. But on September 2, 2016 U.S. Food and Drug Administration banned containing triclocarban and triclosan consumer antiseptic wash products from further marketing in USA because of a potential damage to human health, resulting from extended exposure to antiseptic active ingredients on a regular bases. However the new rule does not not affect consumer hand “sanitizers” or wipes, or antibacterial products used in health care settings. Triclocarban is a limited spectrum antibacterial agent effective in vitro against some strains of staphylococcus, streptococcus, and enterococcus bacteria. The minimum inhibitory concentration has been found to range from 0.5 to 8 mg/L for these various strains. Triclocarban can act by non-specific membrane-destabilizing mechanism; also was suggested, that similar to triclosan, Triclocarban exerts its effect by inhibiting the activity of enoyl-(acyl-carrier protein) (ACP) reductase, widely distributed in bacteria, fungi and plants. As a result, this agent interrupts cell membrane synthesis and leads to bacterial growth inhibition.
Status:
US Previously Marketed
Source:
21 CFR 310.545(a)(18)(vi)(A) skin protectant:poison ivy/oak/sumac cetalkonium chloride
Source URL:

Class (Stereo):
CHEMICAL (ACHIRAL)


Cetalkonium chloride is a cationic quaternary ammonium surfactant, which is used for the treatment of mouth ulcers and sores (Bonjela trade name). It is also serves as an excipient for the purpose of long-term stabilization of ciclosporin ocular formulation, used in patients with dry eye syndrom (Ikervis trade name). The antibacterial properties of cetalkonium can be explained by its detergent character. Once applied, cetalkonium blocks the survival of biofilm forming bacterias.
Status:
US Previously Marketed
First approved in 1964

Class (Stereo):
CHEMICAL (ACHIRAL)

Status:
US Previously Marketed
Source:
21 CFR 310.545(a)(22)(ii) antifungal:diaper rash benzoxiquine
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.
Status:
US Previously Marketed
Source:
Safeguard by Procter & Gamble
(1963)
Source URL:
First approved in 1963
Source:
Safeguard by Procter & Gamble
Source URL:

Class (Stereo):
CHEMICAL (ACHIRAL)


Conditions:

A synthetic, carbanilide compound with antiseptic activity. Cloflucarban is used as disinfectant and is found in antimicrobial soaps and deodorants. Cloflucarban remains Category II as a health care antiseptic for use as a patient preoperative skin preparation and surgical scrub and Category Ill for use as an antiseptic handwash.
Status:
US Previously Marketed
Source:
Safeguard by Procter & Gamble
(1963)
Source URL:
First approved in 1963
Source:
Safeguard by Procter & Gamble
Source URL:

Class (Stereo):
CHEMICAL (ACHIRAL)

Metabromsalan (or 3,5-dibromosalicylanilide) is a pesticide.
Status:
US Previously Marketed
Source:
Amphocortin by Warner/Chilcott
(1963)
Source URL:
First approved in 1963
Source:
Amphocortin by Warner/Chilcott
Source URL:

Class (Stereo):
CHEMICAL (EPIMERIC)

Status:
US Previously Marketed
Source:
Lanesta by Sterling
(1959)
Source URL:
First approved in 1959
Source:
Lanesta by Sterling
Source URL:

Class (Stereo):
CHEMICAL (ACHIRAL)


Chlorindanol is an antiseptic agent which is rapidly leathal to vegetative bacteria (Trichophyton sp., C. albicans, E. histolytica cysts and trophozoites, T. vaginalis) and seprmatozoa in vitro. It is one of two active ingredients in a spermicidal contraceptive aerosol cream (Lanettes); with the other being laureth-9.