FDA label 821e0038-5a99-4f53-a627-bec0bc200598

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: a4808e80-b8e0-4b18-b60c-9bdbb55dbef3
SPL ID: 821e0038-5a99-4f53-a627-bec0bc200598
Version: 1
Effective date: 2013-01-28
Source export date: 2026-10-12
Source partition: 10
Source file: https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/befa34274042a52f589b22fe2add0b1c6f0a385c96447c28303de164bb144af5/drug-label-0010-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 02:37:14

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		821e0038-5a99-4f53-a627-bec0bc200598	id
spl set id		a4808e80-b8e0-4b18-b60c-9bdbb55dbef3	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

WARNINGS DO NOT SWALLOW. Keep out of reach of infants and children. Pediatric populations under the age of 12 years should be supervised in the use of this product. Patients under the age of 6 years require special supervision to prevent repeated swallowing of the rinse since they may frequently swallow large amounts while rinsing. Prolonged daily ingestion may result in dental fluorosis in patients under the age of 6 years, especially if water fluoridation exceeds 0.6 ppm. Read directions before using.

Adverse reactions cross-check#

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

Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS In patients with mucositis, gingival tissues may be hypersensitive to flavor present in the formulation. Allergic reactions are rarely reported.

Reported adverse events (FAERS/openFDA)#

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