FDA label d51ecb55-a8a1-4822-bee1-bd616a7484af

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
933a6e9b-06a6-4fca-bd28-40362cfbec90
SPL ID
d51ecb55-a8a1-4822-bee1-bd616a7484af
Version
9
Effective date
2019-12-09
Source export date
2026-09-28
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:13:47

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings Keep out of the reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away. Ask a dentist before use if you have bleeding or redness lasting more than 2 weeks pain, swelling, pus, loose teeth, or more spacing between teeth These may be signs of periodontitis, a serious form of gum disease. Directions Supervise children as necessary until capable of using without supervision. Adults and children 6 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or a physician. Children under 12 years: Instruct in good brushing and rinsing habits (to minimize swallowing). Children under 6 years: Do not use unless directed by a dentist or a physician. Antiplaque and antigingivitis use not proven in children. Inactive ingredients Water, hydrated silica, glycerin, sorbitol, PVM/MA copolymer, sodium lauryl sulfate, cellulose gum, flavor, sodium hydroxide, propylene glycol, carrageenan, sodium saccharin, titanium dioxide

Reported adverse events (FAERS/openFDA)#

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