FDA label c481a645-4967-4efb-a94a-7e7a2079487f

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
ec19f244-662c-4643-8be0-6d96a0d07801
SPL ID
c481a645-4967-4efb-a94a-7e7a2079487f
Version
4
Effective date
2019-01-28
Source export date
2026-10-12
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/befa34274042a52f589b22fe2add0b1c6f0a385c96447c28303de164bb144af5/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:33:05

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 if you are allergic to chlorhexidine gluconate or any other ingredients in this product as a patient preoperative skin preparation (especially of the head and face) in contact with meninges in the genital area When using this product keep out of eyes, ears, and mouth. May cause serious and permanent eye injury if permitted to enter or allowed to remain if contact occurs, rinse with cold water right away do not use routinely if you have wounds which involve more than the superficial layers of the skin Stop use and ask a doctor if irritation, sensitization, or allergic reaction occurs and lasts more than 72 hours Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Warning This product contains a chemical (cocamide DEA) known to the State of California to cause cancer.

Reported adverse events (FAERS/openFDA)#

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