FDA.reportPublic FDA data

FDA label 9fee8639-e017-45f6-88ed-18987cdc0df5

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
4181bd53-8bd3-4507-beb4-562000d011d8
SPL ID
9fee8639-e017-45f6-88ed-18987cdc0df5
Version
2
Effective date
2018-12-13
Source export date
2026-08-08
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-08/1742e81476d3d6cada20c9e3894391dc6e407b1d0da716d0da13f6f74451bfd1/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
b39f3b00ad50d2e1b32aaf429248c6081e8799b35bce715b4fccb8cfa1ac4546
Import run
20260810T161303Z
Imported at
2026-08-10 16:59:19

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: This Packet contains sodium fluoride powder, contents poisonous if swallowed. keep away from children. Store in a dry place at controlled room temperature. For professional use only. DO NOT SWALLOW MISSUSE If child swallows dispensed amount of mouth rinse in a cup: 1. Do not panic -this amount should not hurt the child 2. In rare cases the child may feel slightly nauseous. The child may have a serving of milk or ice cream to relieve the nausea. EMERGENCY TREATMENT If a child swallows more than one dispensed amount in a cup or powder contents of the fluoride mouth rinse packet call the Poison Control Center at 800-222-1222