FDA.reportPublic FDA data

FDA label 677b83a5-38c8-4f05-8e9f-77cdfeb893be

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
65a1d6dc-3714-48c8-a814-d7f12df2560f
SPL ID
677b83a5-38c8-4f05-8e9f-77cdfeb893be
Version
2
Effective date
2020-08-25
Source export date
2026-09-28
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:02:03

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 2 matching rows.

warnings

Warnings For external use only. Flammable. Keep away from jeat or flame. Do not use In children less than 2 months of age On open skin wounds When using this product keep out of eyes, ears and mouth. I case of contact with eyes, rinse eyes thoroughly with water. Stop use and ask a doctor if irritation or rash occurs. These may be signs of serious condition. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

warnings

Warnings For external use only. Flammable. Keep away from heat or flame. Do not use In children less than 2 months of age On open skin wounds When using this product keep out of eyes, ears and mouth. I case of contact with eyes, rinse eyes thoroughly with water. Stop use and ask a doctor if irritation or rash occurs. These may be signs of serious condition. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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