Rx Item-Ketoconazole 2% 4 OZ Shampoo by Tolmar Pharma USA , Clinical Information:
Generic Code And Description: 15568 Ketoconazole Topical Shampoo 2 %
Strength: 2 %
Dose Form: Shampoo
Product Category: : Rx Pharmaceuticals
Fine Line Class: 850085008510 All Rx Products
DEA Class: None Omp Family:
Drug Class: 84040808 Azoles (Skin And Mucous Membrane)
Active Ingredients: 2903 Ketoconazole 65277421
Inactive Ingredients: 10141 Red Dye Drug Class: Drug Class: 84040808 Azoles (Skin And Mucous Membrane) , OMP Family: , Temparature Zone: 10 Room Temperature, Unit Dose Indicator: NO, Item Size: 4OZ, Brand Label Flag: GENERIC , Storage Temperature Zone: 10 Room Temperature, Item Size Code:4OZ, Item Strength Code:2% , Item Abbreviation: Ketoconazole , Generic Form: SHM
Ketoconazole Shampoo, 2% For topical application only. Rx only
DESCRIPTION
Ketoconazole shampoo, 2%, is a red-orange liquid for topical application, containing the broad spectrum synthetic antifungal agent ketoconazole in a concentration of 2% in an aqueous suspension ...
CLINICAL PHARMACOLOGY
Tinea (pityriasis) versicolor is a non-contagious infection of the skin caused by Pityrosporum orbiculare (Malassezia furfur). This commensal organism is part of the normal skin flora. In ...
INDICATIONS AND USAGE
Ketoconazole shampoo, 2%, is indicated for the treatment of tinea (pityriasis) versicolor caused by or presumed to be caused by Pityrosporum orbiculare (also known as Malassezia furfur or M ...
CONTRAINDICATIONS
Ketoconazole shampoo, 2%, is contraindicated in persons who have known hypersensitivity to the active ingredient or excipients of this formulation.
PRECAUTIONS
Severe hypersensitivity reactions, including anaphylaxis, have been reported during post-marketing use of ketoconazole shampoo, 2%. If a reaction suggesting sensitivity or chemical irritation ...
ADVERSE REACTIONS
Clinical Trials Experience - In 11 double-blind trials in 264 patients using ketoconazole shampoo, 2%, for the treatment of dandruff or seborrheic dermatitis, an increase in normal hair loss and ...
OVERDOSAGE
Ketoconazole shampoo, 2%, is intended for external use only. In the event of accidental ingestion, supportive and symptomatic measures should be employed. Induced emesis and gastric lavage should ...
DOSAGE AND ADMINISTRATION
Apply the shampoo to the damp skin of the affected area and a wide margin surrounding this area. Lather, leave in place for 5 minutes, and then rinse off with water. One application of the shampoo ...
HOW SUPPLIED
Ketoconazole Shampoo, 2%, is a red-orange liquid supplied in a 4-fluid ounce nonbreakable plastic bottle (NDC 63646-010-04). Storage conditions: Store at 20ºC to 25ºC (68ºF to 77ºF) [see USP ...
PRINCIPAL DISPLAY PANEL
Tolmar-front ...
INGREDIENTS AND APPEARANCE
Product Information
