FDA label c54ddf63-3873-1525-e053-2a95a90a9853

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: 19c2d14d-2d89-6f16-e054-00144ff8d46c
SPL ID: c54ddf63-3873-1525-e053-2a95a90a9853
Version: 4
Effective date: 2022-01-06
Source export date: 2026-09-28
Source partition: 12
Source file: https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:23:06

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 2 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
spl id		c54ddf63-3873-1525-e053-2a95a90a9853	id
spl set id		19c2d14d-2d89-6f16-e054-00144ff8d46c	set_id

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 and cautions

Warnings For external use only. Do not use on damaged or broken skin. When using this product, keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash and irritation develops and lasts. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center immediately. Keep out of reach of children. Keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash and irritation develops and lasts. Stop use if rash and irritation develop and lasts.

Reported adverse events (FAERS/openFDA)#

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