XOLEGEL- ketoconazole gel
Aqua Pharmaceuticals, LLC.
1 INDICATIONS AND USAGE
XOLEGEL is indicated for the topical treatment of seborrheic dermatitis in immunocompetent adults and children 12 years of age and older.
Safety and efficacy of XOLEGEL for treatment of fungal infections have not been established.
2 DOSAGE AND ADMINISTRATION
XOLEGEL is for topical use only, and not for oral, ophthalmic, or intravaginal use.
XOLEGEL should be applied once daily to the affected area for 2 weeks.
3 DOSAGE FORMS AND STRENGTHS
XOLEGEL is a translucent to clear amber colored gel containing 2% ketoconazole.
4 CONTRAINDICATIONS
None.
5 WARNINGS AND PRECAUTIONS
5.1 Flammable Contents
XOLEGEL is flammable. Avoid being near fire, flame, or smoking during and immediately following application of XOLEGEL.
5.2 Systemic Effects
Hepatitis and, at high doses, lowered testosterone and ACTH induced corticosteroid serum levels have been seen with orally administered ketoconazole; these effects have not been seen with topically administered ketoconazole.
5.3 Local Effects
XOLEGEL can cause local irritation at the application site. If irritation occurs or if the disease worsens, use of the medication should be discontinued and the health care provider should be contacted.
DESCRIPTION
XOLEGEL contains the antifungal agent ketoconazole USP at 2% in a topical anhydrous gel vehicle for topical administration.
Chemically, ketoconazole is (�)-cis-1-Acetyl-4-[p-[[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazine, with the molecular formula C26 H28 Cl2 N4 O4 and a molecular weight of 531.43.
Each gram contains: 20 mg ketoconazole USP, dehydrated alcohol (34%), ascorbic acid, butylated hydroxytoluene, citric acid monohydrate, glycerin, hydroxypropyl cellulose, polyethylene glycol 400, PPG-15 stearyl ether, propylene glycol, FD&C yellow No. 6, and FD&C yellow No. 10.
XOLEGEL is a smooth, translucent to clear, amber gel.
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
The mechanism of action of ketoconazole in the treatment of seborrheic dermatitis is unknown.
HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
XOLEGEL� (ketoconazole) Gel, 2% is supplied in 45-gram (NDC 16110-080-45) white-coated aluminum tubes with white caps, and is dispensed with FDA-Approved Patient Labeling. (17)
16.2 Storage and Handling
Store at 25�C (77�F); excursions permitted to 15� - 30�C (59� - 86�F).
Contents are flammable.
Keep out of reach of children.
