Dr Butlers Hemorrhoid and Fissure PF

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)

Brand name
Dr Butlers Hemorrhoid and Fissure PF
Generic name
LIDOCAINE 4.00, PHENYLEPHRINE HYDROCHLORIDE 0.25
Manufacturer
Beyond Health P.A.
Product type
HUMAN OTC DRUG
SPL set ID
f526199e-5c9e-7a3c-e053-2a95a90aa98e
SPL ID
44848a07-eb1f-3040-e063-6294a90a1762
Version
5
Effective date
2025-11-26
Source export date
2026-09-28
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:38:45
Harmonized routes table
Harmonized routes
TOPICAL

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings For external use only including the skin of the anal canal. When using this product do not exceed recommended dosage unless directed by a doctor when using finger cots or an applicator, apply externally or to the skin of the anal canal only. Do not put this product into the rectum Ask a doctor before use if you have allergies to any of the components of this product difficulty in urination due to enlargement of the prostate gland Diabetes Heart Disease High Blood Pressure Thyroid Disease presently taking a prescription for high blood pressure or depression Stop use and ask a doctor if condition worsens or does not improve within seven (7) days bleeding occurs an allergic reation develops the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase If pregnant or breast-feeding as a health care professional before use. Keep out of reach of children if swallowed, seek 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.