Tavaborole Topical Solution

SPL v2

SPL

SPL Set ID 15bc62dc-4f5e-4d43-a125-d1f00bee84a5

Route

TOPICAL

Published

Effective Date 2023-04-12

Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Tavaborole (43.5 mg)

Inactive Ingredients

Alcohol Edetate Calcium Disodium Propylene Glycol

Identifiers & Packaging

Marketing Status

ANDA Active Since 2023-04-24

Description

NDC 70771-1826-0 Tavaborole topical solution, 5% 10 mL Rx only

Medication Information

Description

NDC 70771-1826-0 Tavaborole topical solution, 5% 10 mL Rx only

Package Label.principal Display Panel

NDC 70771-1826-0

Tavaborole topical solution, 5%

10 mL

Rx only

Structured Label Content

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

NDC 70771-1826-0

Tavaborole topical solution, 5%

10 mL

Rx only

Advanced Ingredient Data

[{"name": "TAVABOROLE", "unii": "K124A4EUQ3", "classCode": "ACTIB", "strengthNumerator": "43.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETATE CALCIUM DISODIUM", "unii": "25IH6R4SGF", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"PACKAGE LABEL.PRINCIPAL DISPLAY PANEL": "NDC 70771-1826-0 Tavaborole topical solution, 5% 10 mL Rx only"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:44:04.221049 · Updated: 2026-03-14T22:18:33.371936