FDA label b2917c26-a3fc-48a9-b5f0-1d62fe15af74
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
- SPL set ID
- 6989bddc-910e-47e6-aa8f-619a330e81b8
- SPL ID
- b2917c26-a3fc-48a9-b5f0-1d62fe15af74
- Version
- 1
- Effective date
- 2010-02-04
- Source export date
- 2026-10-12
- Source partition
- 2
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/4760f38f2bcb10aa20ddbadb42b270d31e9f2a8024440d3af3dec8d11feb92ec/drug-label-0002-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 01:29:48
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| spl id | b2917c26-a3fc-48a9-b5f0-1d62fe15af74 | id | |
| spl set id | 6989bddc-910e-47e6-aa8f-619a330e81b8 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
5. WARNINGS Do not swallow. Do not allow material to come into contact with intact skin or mucosa. Wear eye protection when handling. Ensure proper tooth isolation, including rubber dam when applying. Keep out of reach of children. For professional dental use only.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
6. DOSAGE AND ADMINISTRATION Intracanal disinfection in permanent teeth: Isolate the tooth with a rubber dam. Clean, de-bride and instrument the canals. Rinse and dry the canal spaces. Moisten a small cotton pellet with formocresol. Blot or wring any excess liquid from the pellet. Place the cotton pellet in the pulp chamber and seal the access hole with a temporary filling material. Recall the patient after a minimum of 48 hours and remove the pellet. Complete the endodontic treatment and restore. Formocresol pulpotomy in primary teeth: Isolate the tooth with a rubber dam. Remove visible caries. Remove the coronal pulp with an excavator or bur leaving the radicular pulp. Achieve hemostasis. Moisten small cotton pellets with fomocresol. Blot or wring any excess liquid from the pellet. Place the pellets directly on the radicular pulp stumps for 5 minutes. Place a base or a core in the tooth and restore.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.