FDA label ecfaaf8d-d4a8-4e7d-bb2a-ac644bbf7a17

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: 8e09eaa5-7697-4397-ac9f-7bdd5c50ae1e
SPL ID: ecfaaf8d-d4a8-4e7d-bb2a-ac644bbf7a17
Version: 2
Effective date: 2015-07-07
Source export date: 2026-08-01
Source partition: 9
Source file: https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-08-01/054d07cb7b0dcd436e53c5bdecbb921b48860de8ff372c4a586941aa9821a276/drug-label-0009-of-0014.json.zip
Source manifest SHA-256: bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run: 20260801T225920Z
Imported at: 2026-08-01 23:20:40

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		ecfaaf8d-d4a8-4e7d-bb2a-ac644bbf7a17	id
spl set id		8e09eaa5-7697-4397-ac9f-7bdd5c50ae1e	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 Keep out of reach of infants and children. Pediatric patients under age 12 should be supervised in the use of this product. Patients under age 6 require special supervision to prevent repeated swallowing of rinse since they frequently swallow significant amounts while rinsing. Prolonged daily ingestion may result in dental fluorosis in patients under age 6, especially if water fluoridation exceeds 0.6 ppm. Read directions carefully 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 or alcohol present in formulation. Allergic reactions and other idiosyncrasies are rarely reported.