FDA label 53bd9eed-c82e-4efc-a073-8f9e8fc166be

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
46a34092-7369-4586-9d5a-5f182d551a5f
SPL ID
53bd9eed-c82e-4efc-a073-8f9e8fc166be
Version
2
Effective date
2016-08-23
Source export date
2026-09-28
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:32:49

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 In rare cases, sensitivity or adverse reactions may be experienced. In such cases immediately remove the disks while preventing swallowing and refer the patient to a physician. Patients less than 12 years old and patients with special needs should remain under professional supervision until the Phocal disks have biodegraded or have been removed. The disks are not intended for systemic ingestion and should be kept out of children's reach. If more than 20 disks are accidently swallowed, seek immediate medical assistance. Phocal should not be applied in sites with: gingival inflammation, immediately prior to or after oral soft tissue surgery and in cases of known allergies to any of the Phocal ingredients. Phocal is to be sold as unbroken boxes with all disks sealed within the blister packs and is to be used for application in the dental office by professionals only. When Phocal treatment is utilized, routine systemic and topical administrations of fluoride should be suspended during the day of application. Recommended storage temperatures are 40°F-78°F (5°C-25°C).

Reported adverse events (FAERS/openFDA)#

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