Hemorrhoidal Ointment

Manufacturer
Geritrex LLC
Effective date
2015-07-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:45:54

Label at a glance#

ProductHemorrhoidal
Active ingredientMINERAL OIL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections

Indications and uses

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

Dosage and administration

Adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing tissue. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this ointment Apply to affected area up to 4 times daily, especially at night, in the morning or after each bowel movement. For Intrarectal use Remove cover from applicator, attach applicator to tube, lubricate appl...

Label contents#

Full prescribing information#

Uses:

INDICATIONS & USAGE SECTION

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

Warnings:

WARNINGS SECTION

For external and/or intrarectal use only

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

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

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or a 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 a doctor if:

OTC - STOP USE SECTION

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

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing tissue.
  • Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this ointment
  • Apply to affected area up to 4 times daily, especially at night, in the morning or after each bowel movement.


For Intrarectal use

  • Remove cover from applicator, attach applicator to tube, lubricate applicator well and gently insert into the rectum.
  • Thoroughly cleanse applicator after each use
  • Also apply ointment to external area
  • Regular use provides continual therapy for relief of symptoms
  • Children under 12 years of age, consult a doctor

Other Information:

OTHER SAFETY INFORMATION

Store at room temperature but not over 80­° F
Lot No. & Exp Date: See tube

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Beeswax, benzoic acid, BHA, corn oil, glycern, lanolin alcohol, methyparaben, paraffin, propylparaben, shark liver oil, thyme, tocopherol, water.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1313818mineral oil 14 % / petrolatum 71.9 % / phenylephrine HCl 0.25 % Rectal OintmentPSN1
1313818mineral oil 0.14 MG/MG / petrolatum 0.719 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal OintmentSCD1
1313818mineral oil 14 % / petrolatum 71.9 % / 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54162-044-022020-01-31C16284748780-19d75b9d0-fbfe-f424-e053-dadaa90a57ceHemorrhoidal Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54162-044-02Hemorrhoidal57 g in 1 TUBE, WITH APPLICATOROINTMENT571

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54162-044HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE) OINTMENT [GERITREX LLC]1Legacy NDC, 1 package rows20160507_6445e94b-8b48-489a-98c8-cae6b0ac33c7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54162-044-02GM - Gram54162-04470f80eaa-2d13-46e1-bccb-9bd956edfd7812016-05-16

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
54162-04454162-044-02

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
59f83f77-c625-4bbc-bca0-2595fd3e27306445e94b-8b48-489a-98c8-cae6b0ac33c72015-07-31WarningsExact identifier
spl id: 59f83f77-c625-4bbc-bca0-2595fd3e2730
spl set id: 6445e94b-8b48-489a-98c8-cae6b0ac33c7

Reported adverse events (FAERS/openFDA)#

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