FDA label bc5775a5-41f9-4b68-a99a-7c30744d04f3

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
5b4b34bb-cba5-409d-beb5-380865f33f63
SPL ID
bc5775a5-41f9-4b68-a99a-7c30744d04f3
Version
2
Effective date
2018-12-14
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 02:07:03

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 Frequent urination can also be caused by: urinary tract infections (UTI) diabetes early pregnancy other more serious conditions If you think you might have one of these conditions, it is important to see your doctor before use. Sleepiness, dizziness, confusion, and blurry vision may occur. Do not drive or operate machinery until you know how the patch affects you. Do not use if you have any of these symptoms, which could be the sign of a UTI or other serious condition. See your doctor as soon as possible if you have: pain or burning when urinating. These symptoms may also be accompanied by a fever or chills. blood in your urine unexplained lower back or side pain urine that is cloudy, or foul-smelling are male. Your symptoms may be due to a more serious condition. are under the age of 18. It is not known if it works or is safe in children. only experience accidental urine loss when you cough, sneeze or laugh, you may have stress incontinence. This product will not work for that condition. have been told by a doctor you have urinary retention (are not able to empty your bladder) have been told by a doctor you have gastric retention (your stomach empties slowly after a meal) have glaucoma are allergic to oxybutyni Ask a doctor before use if you have symptoms of diabetes, such as: excessive thirst extreme hunger unexplained weight loss liver or kidney disease Ask a doctor or pharmacist before use if you are taking a prescription medication for overactive bladder taking any drugs that may cause sleepiness, dizziness, dry mouth, constipation or blurred vision taking certain antibiotics (for example, erythromycin, clarithromycin) or prescription antifungals (for example ketoconazole, itraconazole) When using this product you may have itching, rash or redness where the patch was placed drinking alcohol may increase sleepiness Stop use and ask a doctor if you are not able to empty your bladder (urinary retention) condition worsens, or if new symptoms appear condition does not improve after 2 weeks of use you have an allergic reaction to this product if you have severe redness, itchiness or blistering at the site of application If pregnant or breastfeeding, ask a health professional before 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.