FDA.reportPublic FDA data

FDA label fac0d318-fd4b-b2ce-e053-6394a90ad95c

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
faa824ec-5f3a-d6d1-e053-6294a90adbc5
SPL ID
fac0d318-fd4b-b2ce-e053-6394a90ad95c
Version
3
Effective date
2023-05-02
Source export date
2026-09-28
Source partition
11
Source file
https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:19:26

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

(1) Do not swallow, gargle fully after using. (2) If the use of this paste causes gingiva or oral cavity injury, please stop using and consult a doctor or a dentist. (3) If childern under 6 years of age use, please apply a pea-sized amount each thime. Do not swallow. Please use under the guidance of the guardian. (4) If children under 6 years of age accidentally ingest large amounts of the paste, please consult a doctor or a dentist immediately. (5) Keep out of reach of children under 6 years of age.

Reported adverse events (FAERS/openFDA)#

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