FDA.reportPublic FDA data

FDA label 629ee131-8f57-45ce-8778-50aa7d5d4cb7

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
31e6ba64-e07e-422d-b569-32969f49e16e
SPL ID
629ee131-8f57-45ce-8778-50aa7d5d4cb7
Version
1
Effective date
2014-12-16
Source export date
2026-11-06
Source partition
5
Source file
https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-11-06/f699a9578a0c5d6f5abd59491e85ce3c2c5e4567a51003fee350566c56ba5812/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
8dff71fbef1291eb7711013e9a3a06194930757924a8946ae3034107a98d9463
Import run
20261106T075659Z
Imported at
2026-11-06 08:27:57

Boxed warning cross-check#

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

Boxed warning sections page 1 of 1 · 1 matching rows.

boxed warning

Warnings Warnings For external use only Do not use on damages or broken skin Stop use and ask a doctor if rash occurs When using this product keep out of eyes. Rinse with water to remove. Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away

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

For external use only Do not use on damages or broken skin Stop use and ask a doctor if rash occurs When using this product keep out of eyes. Rinse with water to remove. Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away

Adverse reactions cross-check#

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

Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

-you may report a serious adverse reaction to Jouer Customer support, toll free: 1-800-315-5374, M-F, 8am-6pm PST (US and Canada Only)

Reported adverse events (FAERS/openFDA)#

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