FDA.reportPublic FDA data

FDA label e34ff53c-0dbc-4bb9-9f88-c2adc0a93108

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
a1ea44f1-3a6e-4815-bffa-e702d37d30d4
SPL ID
e34ff53c-0dbc-4bb9-9f88-c2adc0a93108
Version
2
Effective date
2013-08-06
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 06:21:55

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

Warnings For external use only Some users may develop a mild skin irritation. When using this product Keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if Rash or skin irritation develops and becomes severe. Ask a doctor before use On children under 12 years of age. If you are pregnant, breastfeeding or intend to become pregnant within 3 months of use. 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.