FDA.reportPublic FDA data

Best Choice Hemorrhoidal Ointment

Manufacturer
Trifecta Pharmaceuticals USA LLC
Effective date
2024-12-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:45:11

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 Introduction of applicator into the rectum causes additional pain

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 and attach to tube Lubricate applicator well, then gently insert applicat...

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 profects the inflamed, irritated anorectal surface to help make bowel movements less painful
  • Introduction of applicator into the rectum causes additional pain

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

Stop Use and Ask Doctor if

OTC - STOP USE SECTION

  • Bleeding occurs
  • Condition worsens or does not improve within 7 days

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

When using this product

OTC - WHEN USING SECTION

When using this product do not exceed the recommended dosage unless directed by a doctor

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 and attach to tube
  • Lubricate applicator well, then gently insert applicator into rectum
  • Thoroughly clean applicator and replace protective cover after each use
  • Clean the affected area and pat or dab dry before applying ointment
  • 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, Benzoic Acid, Cetyl alcohol, Glycerol Methylparaben, Polyoxyethylene lauryl ether, Propylparaben, Stearyl alcohol

Questions

OTC - QUESTIONS SECTION

Call 1-800-883-0085

Distributed By

SPL UNCLASSIFIED SECTION

Proudly Distributed by

Assocated wholesale grocers inc

kansas city Kansas 66106

Call 1 844 2921112 for product information

www.bestchoicebrand.com

Preparation H is a registered trademark of Glaxosmithkline consumer healthcare holdings US

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Best Choice Hemorrhoidal Ointment 2oz 050923 CDERBest Choice Hemorrhoidal Ointment 2oz 050923 CDER

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1372298mineral oil 14 % / petrolatum 74.9 % / phenylephrine HCl 0.25 % Rectal OintmentPSN2
1372298mineral oil 0.14 MG/MG / petrolatum 0.749 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal OintmentSCD2
1372298mineral oil 14 % / petrolatum 74.9 % / phenylephrine hydrochloride 0.25 % Rectal OintmentSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69396-133-20HemorrhoidalOintment56.8 g in 1 TUBEOINTMENT56.82
69396-133-20HemorrhoidalOintment1 in 1 BOXOINTMENT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69396-133HEMORRHOIDALOINTMENT (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCI) OINTMENT [TRIFECTA PHARMACEUTICALS USA LLC]2Current NDC, 2 package rows20241220_fe18fa61-83f9-8bf9-e053-6294a90a7585.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
69396-13369396-133-20

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
BENZOIC ACID8SKN0B0MIMIACT
PROPYLPARABENZ8IX2SC1OHIACT
METHYLPARABENA2I8C7HI9TIACT
YELLOW WAX2ZA36H0S2VIACT
GLYCERINPDC6A3C0OXIACT
MINERAL OILT5L8T28FGPACTIB
PETROLATUM4T6H12BN9UACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
LAURETH-15002FR4N8OVIACT
STEARYL ALCOHOL2KR89I4H1YIACT
CETYL ALCOHOL936JST6JCNIACT

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 LLCfe18fa61-83f9-8bf9-e053-6294a90a75852024-12-18WarningsExact identifier
ndc (package): 69396-133-20
ndc (product): 69396-133
ndc11 (package): 69396013320
spl id: 298dbfb6-2047-47a1-e063-6294a90a5985
spl set id: fe18fa61-83f9-8bf9-e053-6294a90a7585

Reported adverse events (FAERS/openFDA)#

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