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 ImageLabel 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

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