FDA label ca0130ce-6240-60ff-e053-2995a90aa683

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: 061acc74-eb3e-6887-e054-00144ff8d46c
SPL ID: ca0130ce-6240-60ff-e053-2995a90aa683
Version: 11
Effective date: 2021-08-20
Source export date: 2026-09-28
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/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:09:31

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 2 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
spl id		ca0130ce-6240-60ff-e053-2995a90aa683	id
spl set id		061acc74-eb3e-6887-e054-00144ff8d46c	set_id

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 rectal use only Do not use If individual is sensitive to Benzocaine. If you are presently taking mineral oil, unless directed by a doctor. When abdomen pain, nausea or vomiting are present. For a period longer than 1 week unless directed by a doctor. Stop use and ask a doctor if Symptoms last more than 2 weeks. You have rectal bleeding or fail to have a bowel movement after use. This may indicate a serious condition. Pregnant or lactating women , ask a health professional before use. Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Reported adverse events (FAERS/openFDA)#

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