FDA label 4439d487-0766-41b7-a2c7-5550b9e6209f

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
8e65b92b-710d-4bc4-9774-412e59b24a14
SPL ID
4439d487-0766-41b7-a2c7-5550b9e6209f
Version
1
Effective date
2010-08-24
Source export date
2026-10-12
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/4760f38f2bcb10aa20ddbadb42b270d31e9f2a8024440d3af3dec8d11feb92ec/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:29:41

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings If symptoms worsen, or redness or skin irritation occurs, discontinue product. Some individuals may be sensitive to tea tree or other oils. Begin with a small drop to determine if the product causes any increased redness or irritation and discontinue use if it irritates your skin. If you are pregnant or breast-feeding, ask a health professional before use. Keep out of the reach of children. If accidental ingestion, get medical help or contact a Poison Control Center. For external use only. Do not apply to the eyes or mucous membranes. Keep all medicines out of the reach of children. Product Note: Nail Fungus infections may begin as a white or yellow spot under the tip of your fingernail or toenail. As the nail fungus spreads deeper into your nail, it may cause your nail to discolor, thicken and develop crumbling edges. If condition worsens consult a physician.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.