FDA.reportPublic FDA data

FDA label c2dcf032-66e2-6854-e053-2a95a90ab640

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
beed8392-2281-b8be-e053-2995a90aef9f
SPL ID
c2dcf032-66e2-6854-e053-2a95a90ab640
Version
2
Effective date
2021-05-21
Source export date
2026-08-01
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/2026-08-01/4d7120b2932458966cd5c2f0e3ab49319f616f09498d059c9ff283a8dac64565/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:13:17

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. Stop use and ask a dentist or doctor if sore mouth symptoms do not improve in 7 days irritation, pain or redness worsens swelling, rash or fever develops Do not exceed recommended dosage. WARNINGS Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. PREGNANCY OR BREASTFEEDING If pregnant, or breast-feeding or taking prescription drugs, ask a health care professional - before use