FDA.reportPublic FDA data

Hemorrhoidal Ointment

Manufacturer
Pharmacy Value Alliance, LLC | Trifecta Pharmaceuticals USA LLC
Effective date
2024-12-20
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:47:23

Label at a glance#

ProductHemorrhoidalOintment
Active ingredientMINERAL OIL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE
Label structure17 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

Children under 12 years of age: ask a doctor before use Adults: when practical, clean the affected area by patting or blotting with an appropriate cleansing wipe gently dry by patting or blotting with a tissue or soft cloth before applying when first opening tube, remove foil seal for intrarectal use: remove protective cover from applicator into the rectum lubricate applicator well, then gently insert applicator i...

Storage and handling

Store at room temperature 20°-25°C (68°-77°F)

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Phenylephrine HCI 0.25%

Purpose

OTC - PURPOSE SECTION

Vasoconstrictor

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Mineral Oil 14%

Purpose

OTC - PURPOSE SECTION

Protectant

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Petrolatum 74.9%

Purpose

OTC - PURPOSE SECTION

Protectant

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 anorectal use only

Ask doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland

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

When using this product 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 doctor 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.

Directions

DOSAGE & ADMINISTRATION SECTION

Children under 12 years of age: ask a doctor before use

Adults: when practical, clean the affected area by patting or blotting with an appropriate cleansing wipe

  • gently dry by patting or blotting with a tissue or soft cloth before applying
  • when first opening tube, remove foil seal
  • for intrarectal use: remove protective cover from applicator into the rectum
  • lubricate applicator well, then gently insert applicator into the rectum
  • thoroughly clean applicator and replace protective cover after each use
  • apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
  • also apply ointment to external area

Other Information

STORAGE AND HANDLING SECTION

Store at room temperature 20°-25°C (68°-77°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Beeswax, benzolc acid, Cetyl alcohol, Glycerol, Methylparaben, Polyoxyethylene lauryl ether, Propylparaben, stearyl alcohol

Distributed by:

SPL UNCLASSIFIED SECTION

Pharmacy Value Alliance, LLC.

407 East Lancaster Avenue

Wayne, PA. 19087

www.emersongroup.com

Product of PRC

Hemorrhoidal Ointment

SPL UNCLASSIFIED SECTION

  • Prevents Further Irritation
  • Prompt Soothing Relief from Painful Burning, Itching and Discomfort
  • Shrinks Swollen Hemorrhoidal Tissue
  • Protects Irritated Tissue
  • Relieves Internal and External Discomfort

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hemorrhoid OintmentHemorrhoid Ointment

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1372298mineral oil 14 % / petrolatum 74.9 % / phenylephrine HCl 0.25 % Rectal OintmentPSN5
1372298mineral oil 0.14 MG/MG / petrolatum 0.749 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal OintmentSCD5
1372298mineral oil 14 % / petrolatum 74.9 % / phenylephrine hydrochloride 0.25 % Rectal OintmentSY5

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
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
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
68016-528-002023-03-02C16284748780-1ba0f9c33-22eb-a910-e053-dadaa90a0b85Hemorrhoidal Ointment
68016-528-002023-01-30C16284748780-1ba0f9c33-22eb-a910-e053-dadaa90a0b85Hemorrhoidal Ointment
68016-528-002021-10-26C16284748780-1ba0f9c33-22eb-a910-e053-dadaa90a0b85Hemorrhoidal Ointment
68016-528-002021-01-29C16284748780-1ba0f9c33-22eb-a910-e053-dadaa90a0b85Hemorrhoidal Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-528-00HemorrhoidalOintment57 g in 1 TUBEOINTMENT575
68016-528-00HemorrhoidalOintment1 in 1 BOXOINTMENT15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-528HEMORRHOIDALOINTMENT (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCI) OINTMENT [PHARMACY VALUE ALLIANCE, LLC]5Current NDC, Legacy NDC, 2 package rows20241222_3803a61b-308a-14a9-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68016-52868016-528-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
MINERAL OILT5L8T28FGPACTIB
PETROLATUM4T6H12BN9UACTIB
GLYCERINPDC6A3C0OXIACT
LANOLIN7EV65EAW6HIACT
PROPYLPARABENZ8IX2SC1OHIACT
THYME OIL2UK410MY6BIACT
WHITE WAX7G1J5DA97FIACT
PARAFFINI9O0E3H2ZEIACT
METHYLPARABENA2I8C7HI9TIACT
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB

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
HemorrhoidalOintmentMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCIPharmacy Value Alliance, LLC3803a61b-308a-14a9-e054-00144ff88e882024-12-20WarningsExact identifier
ndc (package): 68016-528-00
ndc (product): 68016-528
ndc11 (package): 68016052800
spl id: 29b76842-546d-6826-e063-6294a90a20a5
spl set id: 3803a61b-308a-14a9-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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