FDA.reportPublic FDA data

CVS Hemorrhoidal Ointment

Manufacturer
Trifecta Pharmaceuticals USA LLC
Effective date
2024-12-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:44:57

Label at a glance#

ProductHemorrhoidalOintment
Active ingredientMINERAL OIL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE
Label structure16 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: When practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or with a soft cloth before applying ointment Apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement Intrarectal Use: Remove cover from applicator, attach applicator to tube, lubricate applicator well, ...

Storage and handling

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

Ask doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty 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 (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

Adults:

  • When practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or with a soft cloth before applying ointment
  • Apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
  • Intrarectal Use: Remove cover from applicator, attach applicator to tube, lubricate applicator well, and gently insert applicator into rectum. thoroughly cleanse applicator after each use and replace cover.
  • Also apply ointment to external area
  • Regular use provides continual therapy for relief of symptoms
  • Children under 12 years of age: ask a doctor

Other Information

STORAGE AND HANDLING SECTION

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

Questions? Call 1-888-296-9067

Distributed By

SPL UNCLASSIFIED SECTION

CVS Pharmacy Inc.

One CVS Drive

Woonsocket, RI 02895

©2020 CVS Pharmacy

CVS.com

1-800-SHOP CVS

Made in China

V-36582

CVS Quality Money Back guarantee

This product is not manufactured or distributed by Wyeth LLC, owner of registered trademark Preparation H®

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS Hemorrhoidal Ointment 2ozCVS Hemorrhoidal Ointment 2oz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1372298mineral oil 14 % / petrolatum 74.9 % / phenylephrine HCl 0.25 % Rectal OintmentPSN3
1372298mineral oil 0.14 MG/MG / petrolatum 0.749 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal OintmentSCD3
1372298mineral oil 14 % / petrolatum 74.9 % / phenylephrine hydrochloride 0.25 % Rectal OintmentSY3

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
69396-082-02HemorrhoidalOintment57 g in 1 TUBEOINTMENT573
69396-082-02HemorrhoidalOintment1 in 1 BOXOINTMENT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69396-082HEMORRHOIDALOINTMENT (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCI) OINTMENT [TRIFECTA PHARMACEUTICALS USA LLC]3Current NDC, Legacy NDC, 2 package rows20241220_c50cc6ad-e8a0-47c1-e053-2a95a90a4de6.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
69396-08269396-082-02

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
STEARYL ALCOHOL2KR89I4H1YIACT
CETYL ALCOHOL936JST6JCNIACT
LAURETH-23N72LMW566GIACT
PROPYLPARABENZ8IX2SC1OHIACT
METHYLPARABENA2I8C7HI9TIACT
YELLOW WAX2ZA36H0S2VIACT
GLYCERINPDC6A3C0OXIACT
MINERAL OILT5L8T28FGPACTIB
PETROLATUM4T6H12BN9UACTIB
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 HCITrifecta Pharmaceuticals USA LLCc50cc6ad-e8a0-47c1-e053-2a95a90a4de62024-12-18WarningsExact identifier
ndc (package): 69396-082-02
ndc (product): 69396-082
ndc11 (package): 69396008202
spl id: 298dbfb6-2046-47a1-e063-6294a90a5985
spl set id: c50cc6ad-e8a0-47c1-e053-2a95a90a4de6

Reported adverse events (FAERS/openFDA)#

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