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
Ketoconazole Shampoo, 2%, is a red-orange liquid supplied in a 4-fluid ounce nonbreakable plastic bottle (NDC 68788-8257-1).
Storage conditions: 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
04006031 Rev. 1 09/18
Relabeled By: Preferred Pharmaceuticals Inc.
PRINCIPAL DISPLAY PANEL
| KETOCONAZOLE ketoconazole shampoo, suspension | ||||||||||||||||||||||||
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| Labeler — Preferred Pharmaceuticals Inc. (791119022) |
| Registrant — Preferred Pharmaceuticals Inc. (791119022) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Preferred Pharmaceuticals Inc. | 791119022 | RELABEL (68788-8257) | |
Revised: 09/2022 Preferred Pharmaceuticals Inc.
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