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Search results for "ATC|DERMATOLOGICALS" in comments (approximate match)
Status:
US Approved OTC
Source:
21 CFR 344.12 otic:ear drying aid isopropyl alcohol
Source URL:
First marketed in 1921
Class (Stereo):
CHEMICAL (ACHIRAL)
Isopropanolamine (1-Amino-2-propanol) is a colorless to yellowish liquid with an amine-like odor. It is miscible in water. Intermediate used in the production of dyes, lubrification oils, corrosion inhibitor, detergents, cutting fluids.
Status:
US Approved OTC
Source:
21 CFR 344.1 otic:earwax removal aid carbamide peroxide 6.5% (in anhydrous glycerin)
Source URL:
First marketed in 1921
Class (Stereo):
CHEMICAL (ACHIRAL)
Hydrogen peroxide has been used in medicine for more than 100 years. It is known in surgery as a highly useful irrigation solution by virtue of both its hemostatic and its antimicrobial effects. Hydrogen peroxide is a mild antiseptic used on the skin to prevent infection of minor cuts, scrapes, and burns. It may also be used as a mouth rinse to help remove mucus or to relieve minor mouth irritation (e.g., due to canker/cold sores, gingivitis). This product works by releasing oxygen when it is applied to the affected area. The release of oxygen causes foaming, which helps to remove dead skin and clean the area. Hydrogen peroxide is a strong oxidizing agent used in aqueous solution as a ripening agent, bleach, and topical anti-infective. It is relatively unstable and solutions deteriorate over time unless stabilized by the addition of acetanilide or similar organic materials.
Status:
US Approved OTC
Source:
21 CFR 333.210(d) antifungal povidone-iodine
Source URL:
First marketed in 1921
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Tetraglycine hydroperiodide is an iodine-containing chemical, used for water purification. Tetraglycine hydroperiodide is marketed in tablets; each tablet effectively disinfects 1 liter of clear water or 0.5 liter of tainted water by releasing approximately 8 mg free iodine. It requires approximately 30 minutes to inactivate target microorganisms and make water bacteriologically suitable for drinking. To remove iodine taste, a vitamin C pill is added to the kit.
Status:
US Approved OTC
Source:
21 CFR 346.10(a) anorectal:local anesthetic benzocaine
Source URL:
First marketed in 1895
Class (Stereo):
CHEMICAL (ACHIRAL)
Benzocaine is a local anesthetic. It acts by blocking voltage-gated sodium ion channels in nerve endings. Benzocaine is available over-the counter for local anesthesia of oral and pharyngeal mucous membranes (sore throat, cold sores, mouth ulcers, toothache, sore gums, denture irritation), otic pain, and as a local anesthetic for surgical or diagnostic procedures. As a spray, benzocaine is used for temporary relief of pain and itching associated with minor burns, sunburn, minor cuts or scrapes, insect bites, or minor skin irritations. Topical application of benzocaine to gums or mouth may cause rare, but serious and potentially fatal adverse effect methemoglobinemia.
Status:
US Approved OTC
Source:
21 CFR 346.20(b) anorectal:keratolytic resorcinol
Source URL:
First marketed in 1894
Class (Stereo):
CHEMICAL (ACHIRAL)
Targets:
Conditions:
Resorcinol is a benzenediol. Resorcinol is commonly used in hair dyes and acne medication. Resorcinol works by breaking down rough, scaly, or hardened skin. Resorcinol also disinfects the skin to help fight infection. Resorcinol topical (for the skin) is used to treat pain and itching caused by minor cuts and scrapes, burns, insect bites, poison ivy, sunburn, or other skin irritations. Resorcinol topical is also used to treat acne, eczema, psoriasis, seborrhea, corns, calluses, warts, and other skin disorders. Resorcinol is included in the FDA final rule list of all permitted active ingredients for OTC topical acne products. Permitted combination active ingredient product - Resorcinol in 2 percent concentration in combination with sulfur in concentrations of between 3 and 8 percent. In oxidative hair dyes, resorcinol is regulated to 5% or below in practice, however, many manufacturers limit the level of free resorcinol in oxidative hair dyes to 1.25%. Resorcinol is limited to 0.5% in shampoos and hair lotions. Resorcinol is usually present in anti-acne preparations at a maximum concentration of 2%. The concentration of resorcinol can be much higher in peels, in some cases around 50%. Jessner’s solution (resorcinol in ethyl alcohol, 14% w/v; lactic acid, 14%; and salicylic acid, 14%) is commonly used in chemical peeling. A specialized medical use of resorcinol is in biological glues (gelatin–resorcinol–formaldehyde glue) for cardiovascular surgery, in particular aortic operations.
Status:
US Approved OTC
Source:
21 CFR 358.710(b)(4) dandruff:seborrheic dermatitis salicylic acid
Source URL:
First marketed in 1860
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
Methyl salicylate (or methyl 2-hydroxybenzoate), also known as wintergreen oil, is a natural product and is present in white wine, tea, porcini mushroom Boletus edulis, Bourbon vanilla, clary sage, red sage and fruits including cherry, apple, raspberry, papaya and plum. Methyl salicylate is topically used in combination with methanol and under brand name SALONPAS to temporarily relieves mild to moderate aches and pains of muscles and joints associated with: strains, sprains, simple backache, arthritis, bruises. The precise mechanism of action of methyl salicylate is not known, but there is suggested, that it cause dilation of the capillaries thereby increasing blood flow to the area.
Status:
US Approved Allergenic Extract
(1994)
Source:
BLA103738
(1994)
Source URL:
First approved in 1954
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
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 Approved Allergenic Extract
(1941)
Source:
BLA103888
(1941)
Source URL:
First marketed in 1921
Class (Stereo):
CHEMICAL (ACHIRAL)
Conditions:
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:
XEPI by FERRER INTERNACIONAL
(2017)
Source URL:
First approved in 2017
Source:
XEPI by FERRER INTERNACIONAL
Source URL:
Class (Stereo):
CHEMICAL (ACHIRAL)
Ozenoxacin is an experimental quinolone antibiotic being developed for the treatment of impetigo and other dermatological bacterial infections. Ozenoxacin is active against some bacteria that have developed resistance to currently used quinolone and fluoroquinolone antibiotics. In two phase 3 studies, Ozenoxacin cream, 1%, applied topically twice daily for 5 days vs. placebo, demonstrated superiority on both clinical and bacteriological endpoints, according to the release. Superior bacteriological cure of Ozenoxacin compared to placebo was demonstrated as early as day 4. In both adults and a pediatric population aged 2 months and older, Ozenoxacin treatment was reported to be safe and well tolerated.
Status:
US Previously Marketed
Source:
ALTABAX by ALMIRALL
(2007)
Source URL:
First approved in 2007
Source:
ALTABAX by ALMIRALL
Source URL:
Class (Stereo):
CHEMICAL (ABSOLUTE)
Targets:
Retapamulin is a topical antibiotic which was approved by FDA (Altabax brand name) for the treatment of impetigo due to Staphylococcus aureus (methicillin-susceptible isolates only) or Streptococcus pyogenes. Retapamulin exerts its antibacterial action by binding to 50S subunit of the bacterial ribosome.