Clinical Information
Gen. Code and Des.
63088 ketoconazole TOPICAL FOAM 2 %
GCN and Des.
98848 ketoconazole TOPICAL FOAM 2 %
Strength
2%
Dose Form
FOAM (GRAM)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
84040808 AZOLES (SKIN AND MUCOUS MEMBRANE)
Active Ingredients
2903 ketoconazole 65277421
Inactive Ingredients
2464 alcohol 64175
2468 propylene glycol 57556
These highlights do not include all the information needed to use KETOCONAZOLE FOAM, 2% safely and effectively. See full prescribing information for KETOCONAZOLE FOAM, 2%.
KETOCONAZOLE foam,
for topical use
Initial U.S. Approval: 1981
INDICATIONS AND USAGE
Ketoconazole foam, 2% is indicated for topical treatment of seborrheic dermatitis in immunocompetent patients 12 years of age and older (1).
Limitations of Use
Safety and efficacy of ketoconazole foam for treatment of fungal infections have not been established.
DOSAGE AND ADMINISTRATION
•
Ketoconazole foam, 2% should be applied to the affected area(s) twice daily for four weeks (2).
•
Ketoconazole foam, 2% is not for ophthalmic, oral, or intravaginal use (2).
DOSAGE FORMS AND STRENGTHS
Foam: 2% ketoconazole in 50 g and 100 g containers (3).
CONTRAINDICATIONS
None.
WARNINGS AND PRECAUTIONS
•
Ketoconazole foam, 2% may result in contact sensitization, including photoallergenicity (5.1, 6.2).
•
The contents of ketoconazole foam, 2% are flammable. Avoid fire, flame, or smoking during and immediately following application. (5.2).
ADVERSE REACTIONS
The most common adverse reactions observed in clinical studies (incidence > 1%) were application site burning and application site reaction (6.1).
To report SUSPECTED ADVERSE REACTIONS, contact Xiromed, LLC at 844-XIROMED (844-947-6633) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 4/2020
