FDA.reportPublic FDA data

Hemorrhoidal Ointment

Manufacturer
Rugby | Trifecta Pharmaceuticals USA LLC
Effective date
2024-12-17
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:44:50

Label at a glance#

ProductHemorrhoidal
Active ingredientPHENYLEPHRINE HYDROCHLORIDE, MINERAL OIL, PETROLATUM
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 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 Apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement. For intrar...

Storage and handling

Store at room temperature 20º-25ºC (68º-77ºF)

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 intrarectal 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.

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 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
  • Apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement.
  • For intrarectal use: remove protective cover from applicator and attach to tube. Lubricate applicator well then gently insert applicator into the rectum. Thoroughly clean applicator and replace protective cover after each use.
  • Regular use provides continual therapy for relief of symptoms
  • also apply ointment to external area.

Other Information

STORAGE AND HANDLING SECTION

  • Store at room temperature 20º-25ºC (68º-77ºF)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Beeswax, Benzoic Acid, Cetyl alcohol, Glycerol Methylparaben, Polyoxyethylene lauryl ether, Propylparaben, Stearyl alcohol

Distributed by:

SPL UNCLASSIFIED SECTION

Distributed by RUGBY® LABORATORIES

17177 N. Laurel Park Drive, Suite 233

Livonia, MI. 48152

www.rugbylaboratories.com

Made in China

This Product is not manufactured or distributed by Pfizer Consumer Healthcare, distributor of Preparation H® Hemorrhoidal Ointment.

Questions or Comments?

OTC - QUESTIONS SECTION

1-800-645-2158

Packaging

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 OintmentPSN4
1372298mineral oil 0.14 MG/MG / petrolatum 0.749 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal OintmentSCD4
1372298mineral oil 14 % / petrolatum 74.9 % / phenylephrine hydrochloride 0.25 % Rectal OintmentSY4

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
0536-1288-06Hemorrhoidal57 g in 1 TUBEOINTMENT574
0536-1288-06Hemorrhoidal1 in 1 BOXOINTMENT14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1288HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCI) OINTMENT [RUGBY]4Current NDC, Legacy NDC, 2 package rows20241220_a5b5e0a9-eee9-2a1e-e053-2a95a90a464e.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0536-12880536-1288-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
STEARYL ALCOHOL2KR89I4H1YIACT
BENZOIC ACID8SKN0B0MIMIACT
CETYL ALCOHOL936JST6JCNIACT
LAURETH-23N72LMW566GIACT
METHYLPARABENA2I8C7HI9TIACT
YELLOW WAX2ZA36H0S2VIACT
GLYCERINPDC6A3C0OXIACT
PROPYLPARABENZ8IX2SC1OHIACT
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
MINERAL OILT5L8T28FGPACTIB
PETROLATUM4T6H12BN9UACTIB

Source Document#

Source XML · Source PDF

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
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCIRugbya5b5e0a9-eee9-2a1e-e053-2a95a90a464e2024-12-17WarningsExact identifier
ndc (package): 0536-1288-06
ndc (product): 0536-1288
ndc11 (package): 00536128806
spl id: 297d6588-c5d2-b441-e063-6394a90a8a64
spl set id: a5b5e0a9-eee9-2a1e-e053-2a95a90a464e

Reported adverse events (FAERS/openFDA)#

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