FDA label 28560376-4bc9-4f6d-b306-483eb1465355

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: c14f8518-3642-4bb7-8d59-7aa664e2a381
SPL ID: 28560376-4bc9-4f6d-b306-483eb1465355
Version: 2
Effective date: 2021-03-19
Source export date: 2026-10-12
Source partition: 13
Source file: https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/b8dac220ac9fc8ffb4d86c6e00ece30169fc4575ca0cc92e5c9ce1a524fb0249/drug-label-0013-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 03:03:31

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		28560376-4bc9-4f6d-b306-483eb1465355	id
spl set id		c14f8518-3642-4bb7-8d59-7aa664e2a381	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 and cautions

Warnings/Precautions If irritation (such as redness, swelling, soreness) of the gums or mouth occurs, discontinue use & consult your dentist. Adult supervision is required for use by children under 12. Avoid contact with eyes, skin, or hair; flush with water if contact is made. Avoid swallowing; do not induce vomiting. Do not apply directly to gums or under tongue. Do not use if nursing or pregnant. Keep away from sunlight & heat as contents may pressurize. Use of this product is not intended to cure any disease. Not for systemic use.

Reported adverse events (FAERS/openFDA)#

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