Hemorrhoid Master

Manufacturer
Clinical Resolution Laboratory, Inc.
Effective date
2025-06-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:02:27

Label at a glance#

ProductHemorrhoid Master
Active ingredientLIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Lidocaine 4.00%

Phenylephrine HCl 0.25%

DOSAGE & ADMINISTRATION SECTION

Directions

■ Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. Children under 12 years of age: consult a doctor.

■ For External Use: Apply externally to the affected area up to 4 times daily.

■ For Intrarectal use: Attach applicator to tube. Lubricate applicator well, then gently insert applicator into the rectum. Apply to the affected area up to 4 times daily.

WARNINGS SECTION

Warnings:For external and/ or intrarectal use only.

■ If condition worsens or does not improve within 7 days, consult a doctor.

■ Do not exceed the recommended daily dosage unless directed by a doctor.

■ In case of bleeding, consult a doctor promptly.

■ Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor.

■ Do not use this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.

■ Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression.

■ Do not use this product with an applicator if the introduction of the applicator into the rectum causes additional pain. Consult a doctor promptly.

INDICATIONS & USAGE SECTION

Uses

■ For the temporary relief of local and anorectal itching and discomfort associated with anorectal disorders and anorectal inflammation.

■ For the temporary relief of pain, burning and soreness.

■ Temporarily shrinks hemorrhoidal tissue.

■ Temporarily reduces the swelling associated with irritation in hemorrhoids and other anorectal disorders.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

■ Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. Children under 12 years of age: consult a doctor.

■ For External Use: Apply externally to the affected area up to 4 times daily.

■ For Intrarectal use: Attach applicator to tube. Lubricate applicator well, then gently insert applicator into the rectum. Apply to the affected area up to 4 times daily.

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Ascorbic Acid, Ascorbyl Palmitate, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Seed Oil, Cetearyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Cholecalciferol, Cholesterol, Diisopropyl Sebacate, Dimethyl Isosorbide, Dodecane, Ethoxydiglycol, Ethylhexylglycerin, Glycerin, Hexylene Glycol, Hydrocortisone, Isododecane, Isopropyl Myristate, Lecithin, Mentha Piperita (Peppermint) Oil, Microcrystalline Wax, Mineral Oil, Octyldodecanol, Panax Ginseng Root Extract, PEG-8 Dimethicone, Petrolatum, Phenoxyethanol, Phospholipids, Polyethylene, Propylene Glycol, Punica Granatum Extract, Pyridoxine HCl, Retinyl Palmitate, Silica, Sodium Propoxyhydroxypropyl Thiosulfate Silica, Stearic Acid, Tocopheryl Acetate, Triethoxycaprylylsilane, Water, Zea Mays (Corn) Oil, Zinc Oxide

OTC - PURPOSE SECTION

Purpose

Local Anesthetic

Vasoconstrictor

OTHER SAFETY INFORMATION

Other Information

■ Keep away from direct sunlight or heat.

■ Store at room temperature 15°-30°C (59°-86°F).

■ Keep out of reach of children.

■ In case of accidental overdose or ingestion, call a doctor or poison control center immediately.

■ Do not use this product if seal is broken or missing.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HM Master 4%HM Master 4%

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Packaging LabelPackaging Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2673304lidocaine 4 % / phenylephrine HCl 0.25 % Rectal OintmentPSN1
2673304lidocaine 0.04 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal OintmentSCD1
2673304lidocaine 4 % / phenylephrine HCl 0.25 % Rectal OintmentSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63742-045-01Hemorrhoid Master45 g in 1 TUBE, WITH APPLICATOROINTMENT451

Products#

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

DailyMed product names page 1 of 2 · 47 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63742-04563742-045-01

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 44 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
Hemorrhoid MasterLIDOCAINE, PHENYLEPHRINE HCLClinical Resolution Laboratory, Inc.36caf20d-116a-f86a-e063-6294a90a7b622025-06-04WarningsExact identifier
ndc (package): 63742-045-01
ndc (product): 63742-045
ndc11 (package): 63742004501
spl id: 36caf20d-116b-f86a-e063-6294a90a7b62
spl set id: 36caf20d-116a-f86a-e063-6294a90a7b62

Reported adverse events (FAERS/openFDA)#

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