FDA label 35baf8c5-f5fa-4c47-e054-00144ff8d46c

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
e75703b1-02c1-4b5a-98bd-13c09a17c1a9
SPL ID
35baf8c5-f5fa-4c47-e054-00144ff8d46c
Version
5
Effective date
2016-06-20
Source export date
2026-10-12
Source partition
7
Source file
https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/ff22b88bd32e56cbc369af80345075227138a42b1b3ba9a84f038fd5493a7a47/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:04:50

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. Do not use in eyes. If contact occurs flush with water. Discontinue use if irritation and redness develop. If condition persists for more than 72 hours consult a doctor. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately. Do not use on fabrics. As this preparation contains Benzyl Alcohol, it's use should be avoided on children under two years of age. Not to be used on neonates. Do not use this product on infants under 6 months of age.

Reported adverse events (FAERS/openFDA)#

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