Ketoconazole (Page 2 of 2)

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 not be performed to avoid aspiration.

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 should be sufficient.

HOW SUPPLIED

Product: 50090-3288

NDC: 50090-3288-0 118.28 mL in a BOTTLE, PLASTIC

Storage

Store at 20-25ºC (68-77ºF) [see USP Controlled Room Temperature]. Protect from light. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Manufactured and Distributed by: TOLMAR Inc. Fort Collins, CO 80526

Ketoconazole

Label Image

KETOCONAZOLE ketoconazole shampoo, suspension

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-3288(NDC:63646-010) Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength KETOCONAZOLE (KETOCONAZOLE) KETOCONAZOLE 20.5 mg in 1 mL

Inactive Ingredients Ingredient Name Strength SODIUM LAURETH-3 SULFATE DISODIUM LAURETH SULFOSUCCINATE HYDROCHLORIC ACID IMIDUREA SODIUM CHLORIDE SODIUM HYDROXIDE COCO DIETHANOLAMIDE PEG-120 METHYL GLUCOSE DIOLEATE WATER FD&C RED NO. 40

Product Characteristics Color RED (orange) Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:50090-3288-0 118.28 mL in 1 BOTTLE, PLASTIC None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076942 04/11/2005

Labeler — A-S Medication Solutions (830016429)

Establishment
Name	Address	ID/FEI	Operations
A-S Medication Solutions		830016429	RELABEL (50090-3288)

Revised: 03/2021 A-S Medication Solutions