FDA label 0d76f485-b7e3-50a6-e063-6294a90a56aa

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
d88d5250-2fc1-46da-a312-a2542e226c5d
SPL ID
0d76f485-b7e3-50a6-e063-6294a90a56aa
Version
2
Effective date
2023-12-26
Source export date
2026-10-12
Source partition
8
Source file
https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/fa098e7c5cff0b1ab653ce934059d1f4b90b860bafc0383a1f66223ce1037518/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:12:51

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. avoid contact with the eyes. keep out of reach of children. Do not use this product if pregnant or breastfeeding, ask a health professional before use. Tamper Evident "Do not use this product" if safety seal is broken or missing. you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of prostate gland unless directed by a doctor. When using this product do not exceed the recommended daily usage. certain persons can develop allergic reactions to ingredients in this product. do not put this product into the rectum by using fingers or any medical device or applicator. if swallowed, call your Poison Control Center at 1(800) 222-1222. if condition worsens or does not improve within 7 days, consult a doctor. Stop use and ask a doctor if the symptom being treated does not subside, or redness, irritation, swelling, pain, or other symptoms develop or increase.

Reported adverse events (FAERS/openFDA)#

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