Fluocinonide Topical Solution Usp, 0.05%

SPL v5

SPL

SPL Set ID 72b19e31-49e8-4bd7-8205-997f0c6a43f1

Route

TOPICAL

Published

Effective Date 2022-10-31

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Fluocinonide (0.5 mg)

Inactive Ingredients

Alcohol Citric Acid Monohydrate Diisopropyl Adipate Propylene Glycol Water

Identifiers & Packaging

Marketing Status

ANDA Active Since 2018-11-01

Description

NDC 70771-1375-8 Fluocinonide topical solution USP, 0.05% Rx only 20 mL

Medication Information

Description

NDC 70771-1375-8 Fluocinonide topical solution USP, 0.05% Rx only 20 mL

Package Label.principal Display Panel

NDC 70771-1375-8

Fluocinonide topical solution USP, 0.05%

Rx only

20 mL

Structured Label Content

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

NDC 70771-1375-8

Fluocinonide topical solution USP, 0.05%

Rx only

20 mL

Advanced Ingredient Data

[{"name": "FLUOCINONIDE", "unii": "2W4A77YPAN", "classCode": "ACTIB", "strengthNumerator": "0.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIISOPROPYL ADIPATE", "unii": "P7E6YFV72X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "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 70771-1375-8 Fluocinonide topical solution USP, 0.05% Rx only 20 mL"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:43:58.963262 · Updated: 2026-03-14T22:18:18.443233