FDA.reportPublic FDA data

Hemorrhoidal Ointment

Manufacturer
Trifecta Pharmaceuticals USA LLC
Effective date
2025-06-09
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 01:02:39

Label at a glance#

ProductHemorrhoidalOintment
Active ingredientMINERAL OIL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE
Label structure18 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 profects the inflamed, irritated anorectal surface to help make bowel movements less painful

Dosage and administration

Adults and children 12 years of age and older for topical use: Clean the affected area and pat or dab dry before applying ointment Apply to the affected area up to 4 times daily, especially after bowel movement Attach included applicator to tube Lubricate applicator tip and gently insert into rectum Thoroughly clean applicator after each use and replace cover Children under 12 years of age: ask a doctor before use

Storage and handling

Store at room temperature 20°-25°C (68°-77°F) Close cap tightly after use Questions? Call 1-888-296-9067

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 profects 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

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

Adults and children 12 years of age and older for topical use:

  • Clean the affected area and pat or dab dry before applying ointment
  • Apply to the affected area up to 4 times daily, especially after bowel movement
  • Attach included applicator to tube
  • Lubricate applicator tip and gently insert into rectum
  • Thoroughly clean applicator after each use and replace cover

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

Other Information

STORAGE AND HANDLING SECTION

  • Store at room temperature 20°-25°C (68°-77°F)
  • Close cap tightly after use

Questions? Call 1-888-296-9067

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Distributed By:

SPL UNCLASSIFIED SECTION

Trifecta Pharamceuticals USA, LLC.®

101 NE Third Ave. Suite 1500

Ft. Lauderdale, FL. 33301 USA

www.trifecta-pharma.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4042 HEMORRHOIDAL OINTMENT 2OZ UPC 053025 CDER4042 HEMORRHOIDAL OINTMENT 2OZ UPC 053025 CDER

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

404203-FBA GLOBE HEMORRHOIDAL OINTENT 2OZ 3PK_BOX 060525 CDER404203-FBA GLOBE HEMORRHOIDAL OINTENT 2OZ 3PK_BOX 060525 CDER

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

404204-FBA GLOBE HEMORRHOIDAL OINTMENT 2OZ 4PK_BOX 060525 CDER404204-FBA GLOBE HEMORRHOIDAL OINTMENT 2OZ 4PK_BOX 060525 CDER

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1372298mineral oil 14 % / petrolatum 74.9 % / phenylephrine HCl 0.25 % Rectal OintmentPSN10
1372298mineral oil 0.14 MG/MG / petrolatum 0.749 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal OintmentSCD10
1372298mineral oil 14 % / petrolatum 74.9 % / phenylephrine hydrochloride 0.25 % Rectal OintmentSY10

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
69396-020-01HemorrhoidalOintment1 in 1 BOXOINTMENT110
69396-020-01HemorrhoidalOintment28.4 g in 1 TUBEOINTMENT28.410
69396-020-02HemorrhoidalOintment56 g in 1 TUBEOINTMENT5610
69396-020-02HemorrhoidalOintment1 in 1 BOXOINTMENT110
69396-020-33HemorrhoidalOintment56 g in 1 TUBEOINTMENT5610
69396-020-33HemorrhoidalOintment3 in 1 BOXOINTMENT310
69396-020-44HemorrhoidalOintment56 g in 1 TUBEOINTMENT5610
69396-020-44HemorrhoidalOintment4 in 1 BOXOINTMENT410

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69396-020-02GM - Gram69396-020698cc26a-2995-43a0-9068-d32735766a2d12018-11-06

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
69396-02069396-020-02, 69396-020-01, 69396-020-33, 69396-020-44

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
CETYL ALCOHOL936JST6JCNIACT
BEESWAX2ZA36H0S2VIACT
MINERAL OILT5L8T28FGPACTIB
PETROLATUM4T6H12BN9UACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
PROPYLPARABENZ8IX2SC1OHIACT
METHYLPARABENA2I8C7HI9TIACT
GLYCERINPDC6A3C0OXIACT
BENZOIC ACID8SKN0B0MIMIACT
LAURETH-23N72LMW566GIACT
STEARYL ALCOHOL2KR89I4H1YIACT

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 HCITrifecta Pharmaceuticals USA LLC4eb3c9ac-268a-5246-e054-00144ff88e882025-06-09WarningsExact identifier
ndc (package): 69396-020-01
ndc (package): 69396-020-02
ndc (package): 69396-020-44
ndc (package): 69396-020-33
ndc (product): 69396-020
ndc11 (package): 69396002002
ndc11 (package): 69396002044
ndc11 (package): 69396002001
ndc11 (package): 69396002033
spl id: 37247f04-c552-7e53-e063-6394a90a162e
spl set id: 4eb3c9ac-268a-5246-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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