FDA label 7bd0bacc-8264-39e4-e053-2991aa0a2903

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
894e2ab7-c5a7-40be-8b49-227364e69909
SPL ID
7bd0bacc-8264-39e4-e053-2991aa0a2903
Version
2
Effective date
2018-11-29
Source export date
2026-11-06
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-11-06/39f3c0903357a80632a5484c9d6a804272f4b297080aa9c5a01a84db133f7a03/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 07:57:50

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 use this product for more than 7 days unless directed by a dentist or doctor. When using this product: do not swallow avoid contact with eyes Stop use and ask a doctor if: swelling, rash or fever develops irritation, pain, or redness persists or worsens sore mouth symptoms do not improve in 7 days Keep out of the reach of children. If more than used for rinsing is swallowed, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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