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

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Showing 181 - 190 of 224 results

Status:
US Approved Allergenic Extract (1941)
First marketed in 1921

Class (Stereo):
CHEMICAL (ACHIRAL)


There is not much information about ammonium phenolate. It is known, that this a salt of phenol and it is toxic if swallowed and is toxic in contact with skin.
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)


Lapyrium, or lapirium, as the chloride salt lapirium chloride (INN) or lapyrium chloride (USAN), is a cationic surfactant that is used in cosmetic personal care products as a biocide and antistatic agent. A 50% solution of Lapyrium Chloride produced slight to moderate erythema. Lapyrium is also used in waste-water treatment and corrosion inhibition formulations.
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:
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:
Septiderm by Fougera
(1960)
Source URL:
First approved in 1960
Source:
Septiderm by Fougera
Source URL:

Class (Stereo):
CHEMICAL (ACHIRAL)


Chloroxylenol is used as a preservative in cooling fluids, cosmetics, topical medications, urinary antiseptics and metal working fluids. Products containing Chloroxylenol are used for cleaning and disinfecting wounds, abrasions and abscesses, for minor cuts and scratches, insect bites, burns, inflammation of the skin. It is also found in hair conditioners, toilet cleaners, deodorants, soaps and paste. New use cases continue to be identified. Chloroxylenol has been shown to be effective at reducing the number of pathogenic bacteria in clinical environments. Chloroxylenol has been reviewed and is permitted for use within the European Union (EU) in cosmetic products and is also permitted for use in a number of topical pharmaceutical products as licensed by the UK Medicines and Health Regulatory Agency. Chloroxylenol could cause mild skin irritation in some individuals, or cause an allergic reaction in others. Developed in Europe in the 1920s and used in the United States since the 1950s, Chloroxylenol is one of the most mature antimicrobial agents
Status:
US Previously Marketed
Source:
TRIBURON TRICLOBISONIUM CHLORIDE by ROCHE
(1961)
Source URL:
First approved in 1959
Source:
Triburon by Hoffmann-La Roche
Source URL:

Class (Stereo):
CHEMICAL (MIXED)


TRICLOBISONIUM (as a chloride salt) is an antibacterial agent used for the treatment and/or prevention of local infections.
Status:
US Previously Marketed
Source:
THALAMYD by SCHERING
(1961)
Source URL:
First approved in 1948
Source:
Thalamyd by Schering
Source URL:

Class (Stereo):
CHEMICAL (ACHIRAL)

Status:
US Previously Marketed
Source:
21 CFR 310.545(a)(27)(i) antimicrobial:first aid antiseptic thimerosal
Source URL:

Class (Stereo):
CHEMICAL (ACHIRAL)



Thimerosal is organomercury antiseptic and antifungal agent, used as a preservative in vaccines, immuloglobulins, nasal sprays, contact lens solutions. In USA, European Union countries thiomersal is no longer used in childhood vaccines due to public fears, although the FDA review of 1999 foud no evidence of harm from the use of thimerosal as a vaccine preservative, other than local hypersensitivity reactions. Thimerosal was used as a component of topical antiseptic solution and antiseptic ointment for treating cuts, nasal sprays, eye solutions, vaginal spermicides, diaper rash treatments, but re-evaluation of the drug in 1980-s demonstrated ineffectiveness and toxicity in topical pharmaceutical products, and topical thimerosal was withdrawn from the market. The mechanism of action of thimerosal has not been fully elucidated. It is believed that thimerosal inhibits sulfhydryl-containing active site of various enzymes and binds to sulfhydryl compounds, such as glutathione, cysteine, and SH groups of protein. In addition, thimerosal activates the InsP3 calcium channel on endoplasmic reticular membrane, thereby triggering the release of calcium from intracellular stores resulting in a calcium-induced calcium-influx of extracellular calcium. Consequently, thimerosal may induce or inhibit cellular functions dependent on calcium signaling.
Status:
US Previously Marketed
Source:
Emko Foam by Endo
(1959)
Source URL:
First approved in 1942
Source:
Phemerol Chloride by Parke-Davis
Source URL:

Class (Stereo):
CHEMICAL (ACHIRAL)


Benzethonium chloride, also known as hyamine, is a synthetic quaternary ammonium salt. It has surfactant, antiseptic, and anti-infective properties and it is used as a topical antimicrobial agent in first aid antiseptics. It is also found in cosmetics and toiletries such as mouthwashes, anti-itch ointments, and antibacterial moist towelettes. Benzethonium chloride exhibits a broad spectrum of microbiocidal activity against bacteria, fungi, mold and viruses. The US Food and Drug Administration (FDA) specifies that the safe and effective concentrations for benzethonium chloride are 0.1-0.2% in first aid products. Aqueous solutions of benzethonium chloride are not absorbed through the skin. It is not approved in the US or Europe for use as a food additive. Being a quaternary ammonium salt, it is more toxic than negatively charged surfactants. However, in a two-year study on rats, there was no evidence of carcinogenic activity. Benzethonium chloride was characterized as a novel anticancer compound possessing both in vitro and in vivo efficacy justifying further investigation.

Showing 181 - 190 of 224 results