Hemorrhoid and Fissure

Manufacturer
Beyond Health P.A. | Derma Care Research Labs
Effective date
2025-03-14
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 20:40:31

Label at a glance#

ProductHemorrhoid and Fissure Dr. Butler
Active ingredientPHENYLEPHRINE HYDROCHLORIDE, LIDOCAINE
Label structure6 sections

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Analgesic (pain relief), Vasoconstrictor

INDICATIONS & USAGE SECTION

Helps relieve the anorectal symptoms associated with hemorrhoids (pain, soreness, burning, itching). Temporarily reduces the swelling associated with irritated hemorrhoidal tissue and other anorectal disorders.

WARNINGS SECTION

For external and/or intrarectal use only.

When using this product do not exceed recommended daily dosage unless directed by a doctor.

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 days, bleeding occurs. Introduction of applicator into the rectum causes additional pain.

If pregnant or breastfeeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, seek medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Children under 12 years of age consult your pediatrician.

Adults: apply to affected area up to 3 times daily.

Clean affected area with mild soap and warm water, rinse thoroughly, and then gently dry (patting or blotting) with tissue or soft cloth before use.

To use dispensing cap, attach it to tube, lubricate well then gently insert part way into anus and squeeze tube to deliver medication. Thoroughly cleanse dispensing cap after use with mild soap and warm water and rinse thoroughly.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

labellabel

FDA-Initiated Inactive NDC Indexing#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70942-023HEMORRHOID AND FISSURE DR. BUTLER (LIDOCAINE 4.00, PHENYLEPHRINE HYDROCHLORIDE 0.25) OINTMENT [BEYOND HEALTH P.A.]4Legacy NDC20250316_828039c3-af65-de83-e053-2991aa0a2a93.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 36 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70942-02370942-023-01, 70942-023-11

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
3a87438e-5487-a670-e063-6294a90a3cbe828039c3-af65-de83-e053-2991aa0a2a932025-07-22WarningsExact identifier
spl set id: 828039c3-af65-de83-e053-2991aa0a2a93

Reported adverse events (FAERS/openFDA)#

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