FDA.reportPublic FDA data

FDA label 12454267-cfbc-a489-7929-67744ac2db16

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
c8feea99-8b41-6657-da37-6aa321df09c5
SPL ID
12454267-cfbc-a489-7929-67744ac2db16
Version
1
Effective date
2020-04-13
Source export date
2026-10-12
Source partition
8
Source file
https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/fa098e7c5cff0b1ab653ce934059d1f4b90b860bafc0383a1f66223ce1037518/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:08:15

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. Keep away from open flame and sources of heat. Do not use Do not use on children less than 2 months old. Do not use on open skin wounds. Ask a doctor before use if Information required in 201.66(c)(5)(iv) Ask a doctor or pharmacist before use if Information required in 201.66(c)(5)(v) When using this product When using this product keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water Stop use and ask doctor if Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition. Other required warnings Information required in 201.66 (c)(5)(viii) Pregnancy/Breastfeeding Information required in 201.66(c)(5)(ix) Keep out of reach of children Keep out of reach of children, if swallowed, call a poison control center right away.

warnings

Other required warnings Information required in 201.66 (c)(5)(viii)

Reported adverse events (FAERS/openFDA)#

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