Rx Item-Extina 2% Foam 100Gm By Prestium Pharma

EXTINA- ketoconazole aerosol, foam
Stiefel Laboratories Inc

1 INDICATIONS AND USAGE

EXTINA� (ketoconazole) Foam, 2% is indicated for the topical treatment of seborrheic dermatitis in immunocompetent patients 12 years of age and older. Safety and efficacy of EXTINA� Foam for treatment of fungal infections have not been established.

2 DOSAGE AND ADMINISTRATION

EXTINA� Foam should be applied to the affected area(s) twice daily for four weeks.



Hold the container upright, and dispense EXTINA� Foam into the cap of the can or other cool surface in an amount sufficient to cover the affected area(s). Dispensing directly onto hands is not recommended, as the foam will begin to melt immediately upon contact with warm skin. Pick up small amounts of EXTINA� Foam with the fingertips, and gently massage into the affected area(s) until the foam disappears. For hair-bearing areas, part the hair, so that EXTINA� Foam may be applied directly to the skin (rather than on the hair).

Avoid contact with the eyes and other mucous membranes. EXTINA� Foam is not for ophthalmic, oral or intravaginal use.

3 DOSAGE FORMS AND STRENGTHS

EXTINA� Foam contains 2% ketoconazole in a thermolabile hydroethanolic foam, and is provided in 50 g and 100 g aluminum containers.

4 CONTRAINDICATIONS

None

5 WARNINGS AND PRECAUTIONS

5.1 Contact Sensitization
EXTINA� Foam may result in contact sensitization, including photoallergenicity. [See Adverse Reactions (6.2)]

5.2 Flammable Contents
The contents of EXTINA� Foam include alcohol and propane/butane, which are flammable. Avoid fire, flame and/or smoking during and immediately following application. Do not puncture and/or incinerate the containers. Do not expose containers to heat and/or store at temperatures above 120�F (49�C).

5.3 Systemic Effects
Hepatitis has been seen with orally administered ketoconazole (1:10,000 reported incidence). Lowered testosterone and ACTH�induced corticosteroid serum levels have been seen with high doses of orally administered ketoconazole. These effects have not been seen with topical ketoconazole.

RX ITEM-Extina 2% Foam 100Gm By Prestium
NDC 40076-0051-00 UPC/GTIN No.3-40076-05100-2 Mfg.Part No.605100

Extina 2% Foam 100Gm By Prestium Pharma
BRAND: EXTINA NDC: 40076-0051-00,40076005100 UPC: 3-40076-05100-2,340076051002 Prestium Pharma Inc

KETOCONAZOLE TOPICAL FOAM
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