FDA.reportPublic FDA data

Hemorrhoidal Pain Relief Ointment

Manufacturer
Neilmed Pharmaceuticals Inc.
Effective date
2025-06-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:06:37

Label at a glance#

ProductHemorrhoidal Pain Relief
Active ingredientPETROLATUM, MINERAL OIL, PHENYLEPHRINE HYDROCHLORIDE
Label structure16 sections

Indications and uses

Helps relieve the local itching and discomfort associated with hemorrhoids Temporarily shrinks hemorrhoidal tissue and relieves burning Temporarily provides a coating for relief of anorectal discomforts Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

Dosage and administration

Adults: When practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before applying ointment. When first opening the tube, puncture foil seal with top end of cap. Apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement. Intrarectal use: Remove cover from ...

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients:

Mineral Oil 14%

Petrolatum 74.9%

Phenylephrine HCl 0.25%

Drug Facts:

OTC - PURPOSE SECTION

Purpose

Protectant

Protectant

Vasoconstrictor

Uses:

INDICATIONS & USAGE SECTION

  • Helps relieve the local itching and discomfort associated with hemorrhoids
  • Temporarily shrinks hemorrhoidal tissue and relieves burning
  • Temporarily provides a coating for relief of anorectal discomforts
  • Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

Warnings:

WARNINGS SECTION

For external and/or intrarectal use only

Ask a doctor before use if you have:

OTC - ASK DOCTOR SECTION

  • Heart disease
  • High blood pressure
  • Thyroid disease
  • Diabetes
  • Difficulty in urination due to enlargement of prostate gland

Ask a doctor or pharmacist before use if you are:

OTC - ASK DOCTOR/PHARMACIST SECTION

Presently taking a prescription drug for high blood pressure or depression

When using this product:

OTC - WHEN USING SECTION

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

Stop use and ask doctor if:

OTC - STOP USE SECTION

  • Bleeding occurs
  • Condition worsens or does not improve within 7 days
  • Introduction of applicator into the rectum causes additional pain

If pregnant or breast-feeding:

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Adults: When practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before applying ointment.
  • When first opening the tube, puncture foil seal with top end of cap.
  • Apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement.
  • Intrarectal use: Remove cover from the applicator, attach applicator to tube, lubricate applicator well and gently insert applicator into the rectum, thoroughly cleanse applicator after each use and replace cover.
  • Also apply ointment to external area.
  • Regular use provides continual therapy for relief of symptoms.

Other Information:

OTHER SAFETY INFORMATION

Store at 15°C – 30°C (59°F – 86°F)

  • Children under 12 years of age: ask a doctor

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Benzoic acid, butylated hydroxytoluene, corn oil, glycerin, lanolin, lanolin alcohol, methylparaben, propylparaben, paraffin wax, purified water, thymus vulgaris oil, tocopherol, acetate, white wax

Questions or comments?

OTC - QUESTIONS SECTION

1 (877) 477-8633

TAMPER EVIDENT: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING

Important:

OTHER SAFETY INFORMATION

Please do not discard this printed box and any enclosed printed material. The inside final product may not have all the details you require for the ongoing use of the product.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hemorrhoidal OintmentHemorrhoidal Ointment

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1372298mineral oil 14 % / petrolatum 74.9 % / phenylephrine HCl 0.25 % Rectal OintmentPSN1
1372298mineral oil 0.14 MG/MG / petrolatum 0.749 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal OintmentSCD1
1372298mineral oil 14 % / petrolatum 74.9 % / phenylephrine hydrochloride 0.25 % Rectal OintmentSY1

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13709-334-01Hemorrhoidal Pain Relief57 g in 1 TUBEOINTMENT571
13709-334-01Hemorrhoidal Pain Relief1 in 1 CARTONOINTMENT11

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13709-33413709-334-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
PETROLATUM4T6H12BN9UACTIB
METHYLPARABENA2I8C7HI9TIACT
PARAFFINI9O0E3H2ZEIACT
WATER059QF0KO0RIACT
THYMUS VULGARIS (THYME) OIL2UK410MY6BIACT
LANOLIN7EV65EAW6HIACT
PROPYLPARABENZ8IX2SC1OHIACT
GLYCERINPDC6A3C0OXIACT
MINERAL OILT5L8T28FGPACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
BENZOIC ACID8SKN0B0MIMIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
LANOLIN ALCOHOL884C3FA9HEIACT
WHITE WAX7G1J5DA97FIACT
CORN OIL8470G57WFMIACT

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
Hemorrhoidal Pain ReliefHEMORRHOIDAL PAIN RELIEF OINTMENTNeilmed Pharmaceuticals Inc.374d89b6-9305-9adf-e063-6394a90adb322025-06-11WarningsExact identifier
ndc (package): 13709-334-01
ndc (product): 13709-334
ndc11 (package): 13709033401
spl id: 374d89b6-9306-9adf-e063-6394a90adb32
spl set id: 374d89b6-9305-9adf-e063-6394a90adb32

Reported adverse events (FAERS/openFDA)#

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