DESCRIPTION

Gordochom is an antifungal solution for topical use containing 25% Undecylenic Acid and 3% Chloroxylenol as its active ingredients in a penetrating oil base. Undecylenic Acid is chemically 10 hendecenoic acid having the empirical formula C 11 H 20 O 2 and the chemical bond structure CH 2 =CH (CH 2 )8 CO 2 H.

Undecylenic Acid is a colorless to pale yellow liquid. It is insoluble in water and soluble in alcohol, chloroform and ether.

Chloroxylenol is chemically 2-chloro-5-hydroxy-1,3-dimethylbenzene having the empirical formula C 8 H 9 ClO.

CLINICAL PHARMACOLOGY

Undecylenic Acid is a fungistatic agent employed in the treatment of tinea pedis, ringworm and dermatophytosis.

Chloroxylenol is a topical antiseptic, germicide and antifungal agent effective against a wide variety of causative fungi and yeast organisms. Among those affected by chloroxylenol are candida albicans, aspergillus niger, aspergillus flavus, trichophyton rubrum, trichophyton mentagrophytes, penicillum luteum and epidermophyton floccosum.

The penetrating oil base vehicle serves as a delivery system, enhancing the impregnation of Undecylenic Acid and Chloroxylenol as antimicrobial agents.

INDICATIONS

Cures athlete's foot (tinea pedis), and ringworm (tinea corporis).

CONTRAINDICATIONS

Gordochom is contraindicated in patients who are sensitive to Undecylenic Acid or Chloroxylenol.

WARNINGS

FOR EXTERNAL USE ONLY. Not for opthalmic or optic use. Avoid inhaling and contact with eyes or other mucous membranes. Not to be applied over blistered, raw or oozing areas of skin or over deep puncture wounds.

PRECAUTIONS

If a reaction suggesting sensitivity or chemical irritation should occur with the use of Gordochom, treatment should be discontinued. Use of Gordochom in pregnancy has not been established.

ADVERSE REACTIONS

No significant adverse reactions have been reported. However, attention should be paid to localized hypersensitivity.

DOSAGE AND ADMINISTRATION

Cleanse and dry affected areas. Apply a thin application twice a day (morning and night) to the affected area, or as recommended by your physician. Supervise children in the use of this product. For athlete's foot, pay special attention to the spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily. For athlete's foot and ringworm, use daily for 4 weeks. If condition persists longer, consult a physician. This product has not been proven effective on the scalp or nails.

HOW SUPPLIED

Gordochom is available in 1 oz. bottles with special brush applicator. (NDC 10481-8010-2)

Store at controlled room temperatures (59°-86°F).

For external use only.

Keep out of reach of children.



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