FDA label 47a16b3b-4a8c-6446-e054-00144ff8d46c

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: 47a16b3b-4a8b-6446-e054-00144ff8d46c
SPL ID: 47a16b3b-4a8c-6446-e054-00144ff8d46c
Version: 1
Effective date: 2017-02-03
Source export date: 2026-10-12
Source partition: 5
Source file: https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/13cbfcd236c665f0ee69e2d9141331148dcdff45d1679c92f029cfba27dd74a2/drug-label-0005-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:41:53

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 2 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
spl id		47a16b3b-4a8c-6446-e054-00144ff8d46c	id
spl set id		47a16b3b-4a8b-6446-e054-00144ff8d46c	set_id

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

Warning: The product is intended for topical use only, not for internal use. Not recommended for use by children under 6 years of age. Instruct patient not to eat, drink, or rinse mouth for at least 30 minutes. Do not use if tamper-evident seal is broken. Do not store in direct sunlight.

Reported adverse events (FAERS/openFDA)#

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