Ketoconazole Shampoo, 2%

SPL v2

SPL

SPL Set ID c004ee91-558a-450b-9e4e-d11ab9d28054

Route

TOPICAL

Published

Effective Date 2025-03-12

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Ketoconazole (20 mg)

Inactive Ingredients

Coco Diethanolamide Disodium Laureth Sulfosuccinate Fd&c Red No. 40 Hydrochloric Acid Imidurea Peg-120 Methyl Glucose Dioleate Sodium Chloride Sodium Laureth-3 Sulfate Water

Identifiers & Packaging

Marketing Status

ANDA Active Since 2025-03-08

Description

NDC 70771-1874-7 Ketoconazole Shampoo, 2% For Topical Application Only 4 FL OZ (120 mL) Rx Only Front Image Back image

Medication Information

Description

NDC 70771-1874-7 Ketoconazole Shampoo, 2% For Topical Application Only 4 FL OZ (120 mL) Rx Only Front Image Back image

Package Label.principal Display Panel

NDC 70771-1874-7

Ketoconazole Shampoo, 2%

For Topical Application Only

4 FL OZ (120 mL)

Rx Only

Front Image

Back image

Structured Label Content

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

NDC 70771-1874-7

Ketoconazole Shampoo, 2%

For Topical Application Only

4 FL OZ (120 mL)

Rx Only

Front Image

Back image

Advanced Ingredient Data

[{"name": "KETOCONAZOLE", "unii": "R9400W927I", "classCode": "ACTIB", "strengthNumerator": "20", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "COCO DIETHANOLAMIDE", "unii": "92005F972D", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DISODIUM LAURETH SULFOSUCCINATE", "unii": "D6DH1DTN7E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROCHLORIC ACID", "unii": "QTT17582CB", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "IMIDUREA", "unii": "M629807ATL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEG-120 METHYL GLUCOSE DIOLEATE", "unii": "YM0K64F20V", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CHLORIDE", "unii": "451W47IQ8X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM LAURETH-3 SULFATE", "unii": "BPV390UAP0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"PACKAGE LABEL.PRINCIPAL DISPLAY PANEL": "NDC 70771-1874-7 Ketoconazole Shampoo, 2% For Topical Application Only 4 FL OZ (120 mL) Rx Only Front Image Back image"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:46:07.917804 · Updated: 2026-03-14T22:24:05.784289