Hemorrhoidal

Manufacturer
NeilMed Pharmaceuticals Inc.
Effective date
2025-01-24
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:54:01

Label at a glance#

ProductHemorrhoidal
Active ingredientPHENYLEPHRINE HYDROCHLORIDE, PETROLATUM, MINERAL OIL
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 ...

Storage and handling

Store at 15°C - 30°C (59°F - 86°F).

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Mineral oil 14%

Petrolatum 74.9%
Phenylephrine Hydrochloride 0.25%

OTC - PURPOSE SECTION

Active Ingredients Purpose
Mineral oil 14% ..................................................................... Protectant
Petrolatum 74.9%................................................................. Protectant
Phenylephrine Hydrochloride 0.25% ...............................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

Warnings: For external and/or intrarectal use only

Ask a doctor before use if you have:

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have:

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

Ask a doctor or pharmacist before use

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are 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

Stop use and ask doctor if: 􀁑􀀃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

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. 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 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.

􀁑􀀃Children under 12 years of age: ask a doctor.

Other information:

STORAGE AND HANDLING SECTION

Store at 15°C - 30°C (59°F - 86°F).

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

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

SAFE HANDLING WARNING SECTION

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

OTHER SAFETY INFORMATION

Important: 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 OintmentPSN3
1372298mineral oil 0.14 MG/MG / petrolatum 0.749 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal OintmentSCD3
1372298mineral oil 14 % / petrolatum 74.9 % / phenylephrine hydrochloride 0.25 % Rectal OintmentSY3

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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13709-319-012025-02-01C16284748780-12cef2736-6419-d83d-e063-dadaa90ab31f038a2cf5-1b72-227b-e063-6394a90a84ad

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13709-319-01Hemorrhoidal57 g in 1 TUBEOINTMENT573
13709-319-01Hemorrhoidal1 in 1 CARTONOINTMENT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13709-319HEMORRHOIDAL (PAIN RELIEF) OINTMENT [NEILMED PHARMACEUTICALS INC.]3Current NDC, 2 package rows20250131_038a2cf5-1b72-227b-e063-6394a90a84ad.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13709-31913709-319-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 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
HemorrhoidalPAIN RELIEFNeilMed Pharmaceuticals Inc.038a2cf5-1b72-227b-e063-6394a90a84ad2025-01-24WarningsExact identifier
ndc (package): 13709-319-01
ndc (product): 13709-319
ndc11 (package): 13709031901
spl id: 2c7264d0-e726-00c1-e063-6394a90af070
spl set id: 038a2cf5-1b72-227b-e063-6394a90a84ad

Reported adverse events (FAERS/openFDA)#

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