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

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Showing 1 - 10 of 25 results

Status:
US Approved OTC
Source:
21 CFR 333.310(a) acne benzoyl peroxide
Source URL:

Class (Stereo):
CHEMICAL (ACHIRAL)

Conditions:

Benzoyl peroxide (BPO) is an organic compound in the peroxide family. It consists of two benzoyl groups bridged by a peroxide link. It is one of the most important organic peroxides in terms of applications and the scale of its production. Benzoyl peroxide is used as an acne treatment, for bleaching hair and teeth. Adverse reactions are: dryness and urticarial reaction, contact dermatitis, application site burning, application site irritation and skin irritation.
Status:
US Approved OTC
Source:
21 CFR 333.210(g) antifungal clotrimazole
Source URL:
First approved in 1975

Class (Stereo):
CHEMICAL (ACHIRAL)



Clotrimazole is an anti-fungal medicine indicated for the treatment of vaginal yeast infections and tinea. It can be used either in combination with other drugs (betamethasone dipropionate) or alone, in form of topical or vaginal cream. The drug exerts its action by inhibiting lanosterol demethylase thereby affecting the growth of fungi.
Haloprogin is an active synthetic antifungal and antimonilial agent that was effective in the treatment of superficial fungal and monilial infections of the skin. Because of these two basic therapeutic effects, haloprogin was especially useful in the treatment of infections when the identity of the specific causative organism had not been established or is being determined. Studies in-vitro demonstrated antifungal, antimonilial and antibacterial activity. It was shown to demonstrate marked in-vitro activity against Staphylococcus and Streptococcus. Haloprogin is no longer available in the US.
Status:
US Approved OTC
Source:
21 CFR 333.210(e) antifungal tolnaftate
Source URL:
First approved in 1965
Source:
Tinactin by Schering
Source URL:

Class (Stereo):
CHEMICAL (ACHIRAL)



Tolnaftate is a thiocarbamate derivative used as an over-the-counter anti-fungal agent for treatment of athlete's foot and ringworm. Tolnaftate acts by inhibition of ergosterol biosynthesis pathway in fungal cells.
Status:
US Approved OTC
Source:
21 CFR 333.210(a) antifungal clioquinol
Source URL:
First approved in 1961

Class (Stereo):
CHEMICAL (ACHIRAL)


Clioquinol is a broad-spectrum antibacterial with antifungal properties, bacteriostatic. It is used as an antifungal and antiprotozoal topical drug OTC product for treatment of human infections. Previousely was used for wide number of intestinal disorders including lambliasis, shigellosis, balantidiral dysentery and some forms of diarrheas. The physiologic effect of clioquinol is by increased histamine release and cell-mediated immunity. It is a member of a family hydroxyquinolines which inhibit certain enzymes related to DNA replication. It is a copper, iron and zink chelating agent. It is an organic molecule with a quinolinic acid as its apparent core which itself is a neurotransmitter. In large doses it possesses neurotoxicity and may induce neurological disease such as subacute myelo-optic neuropathy by creating copper deficiency that leads to zink excess. SMON (Sub-Acute-Myelo-Optical-Neuropathy) - a polio-like disease began as an epidemic in 1959 in Japan was believed to be a Clioquinol caused. Clioquinol is a standardized chemical allergen. It has been resurrected as a potential treatment for Alzheimer's disease since it perturbs metallo-chemistry of amyloid and clioquinol treatment has been shown to be beneficial in a mouse model of Alzheimer's disease.
Status:
US Approved OTC
Source:
21 CFR 333.210(f) antifungal calcium undecylenate
Source URL:
First approved in 1961
Source:
CALDECORT OINTMENT CALCIUM UNDECYLENATE by PENNWALT
Source URL:

Class (Stereo):
CHEMICAL (ACHIRAL)


Conditions:

Calcium Undecylenate is the calcium salt of undecylenic acid, an 11 carbon mono-unsaturated fatty acid with broad-spectrum antifungal activity. Undecylenic acid inhibits the morphogenesis of Candida albicans to its invasive fungal form and inhibits the conversion of unicellular yeast to their hyphal form.
Status:
US Approved OTC
Source:
21 CFR 333.210(f) antifungal copper undecylenate
Source URL:
First approved in 1961
Source:
DECUPRYL COPPER UNDECYLENATE by TILDEN YATES
Source URL:

Class (Stereo):
CHEMICAL (ACHIRAL)


Conditions:

Copper undecylenate was used for the therapy of cutaneous dermatomycoses combined with a wetting agent and dissolved in a fat-solvent base. Undecylenic acid inhibits the morphogenesis of Candida albicans to its invasive fungal form and inhibits conversion of unicellular yeast to their hyphal form.
Status:
US Approved OTC
Source:
21 CFR 333.210(f) antifungal undecylenic acid
Source URL:
First approved in 1945
Source:
Desenex Sol. by Pennwalt
Source URL:

Class (Stereo):
CHEMICAL (ACHIRAL)



Undecylenic acid is unsaturated fatty acid, which naturally occurs in sweat, and is commercially produced by the vacuum distillation of castor bean oil. It is recognized as GRASE by FDA, and is marketed over the counter to treat skin infections and to relieve itching. Undecylenic acid acts by inhibition of morphogenesis from yeast to hyphae forms.
Status:
US Approved OTC
Source:
21 CFR 333.310(c) acne resorcinol monoacetate (when combined with sulfur)
Source URL:

Class (Stereo):
CHEMICAL (ACHIRAL)

Conditions:

Resorcinol Acetate is used as an ingredient to reduce the number of acne blemishes, acne pimples, blackheads, and whiteheads. In the United States, anti-acne agents are regulated as Over-the-Counter (OTC) drug ingredients. Resorcinol Acetate is also used to enhance the appearance and feel of hair, by increasing hair body, suppleness, or sheen, or by improving the texture of hair that has been damaged physically or by chemical treatment and to enhance the appearance of dry or damaged skin by reducing flaking and restoring suppleness.
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.