FDA.reportPublic FDA data

HEB Hemorrhoidal Ointment

Manufacturer
H-E-B | Natureplex LLC
Effective date
2018-10-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:57:06

Label at a glance#

ProductHEB Hemorrhoidal
Active ingredientMineral Oil, Petrolatum, Phenylephrine Hydrochloride
Label structure9 sections

Indications and uses

For the temporary relief of anorectal itching and discomfort associated with hemorrhoids. Temporarily reduces swelling associated with irritation in hemorrhoids and other anorectal disorders Temporarily shrinks hemorrhoidal tissue Temporarily forms a protective coating over inflamed tissues to help prevent drying of tissues Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements...

Dosage and administration

Adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing pad. Gently dry by patting or blotting with a tissue or a soft cloth before application of this product apply externally to the affected area up to 4 times daily intrarectal use: remove cover from applicator, attach applicator to tube, lubricate applicator well and gently insert applicator into the rectum, thorou...

Storage and handling

Store at 15 to 30°C(59 to 86°F) Tamper Evident: DO NOT USE IF SEAL ON TUBE IS BROKEN OR MISSING.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Mineral Oil 14%Protectant
Petrolatum 74.9%Protectant
Phenylephrine hydrochloride 0.25%Vasoconstrictor

Uses

INDICATIONS & USAGE SECTION

  • For the temporary relief of anorectal itching and discomfort associated with hemorrhoids.
  • Temporarily reduces swelling associated with irritation in hemorrhoids and other anorectal disorders
  • Temporarily shrinks hemorrhoidal tissue
  • Temporarily forms a protective coating over inflamed tissues to help prevent drying of tissues
  • Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

Warnings

WARNINGS SECTION

For external and/or intrarectal use only

OTC - DO NOT USE SECTION

Do not use this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • presently taking a prescription drug for high blood pressure or depression.

When using this product

OTC - WHEN USING SECTION

  • do not exceed the recommended daily dosage unless directed by a doctor

Stop use and ask a physician if

OTC - STOP USE SECTION

  • bleeding occurs
  • condition worsens or does not improve within 7 days
  • introduction of applicator into rectum causes additional pain

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing pad. Gently dry by patting or blotting with a tissue or a soft cloth before application of this product
  • apply externally to the affected area up to 4 times daily
  • intrarectal use: remove cover from applicator, attach applicator to tube, lubricate applicator well and gently insert applicator into the rectum, thoroughly cleanse applicator after each use and replace cover
  • Children under 12 years of age: consult a physician

Other information

STORAGE AND HANDLING SECTION

  • Store at 15 to 30°C(59 to 86°F)
  • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS BROKEN OR MISSING.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Benzoic acid, cera alba (bees wax), glycerin, lanolin, lanolin alcohol, methylparaben, paraffin, propylparaben, purified water, thymus vulgaris (thyme) oil, tocopherol (vitamin E) acetate

Questions or comments?

OTC - QUESTIONS SECTION

866-323-0107

PRINCIPAL DISPLAY PANEL - 56.7 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to Preperation H® Ointment active ingredients*

H-E-B ®

NDC 37808-991-24

Hemorrhoidal Ointment
Mineral Oil / Petrolatum / Protectant
Phenylephrine Hydrochloride / Vasoconstrictor

Includes
Dispensing
Cap

Hemorrhoid Symptom Relief

  • Helps Relieve Pain & Itching
  • Lubricating Coating Protects Irritated Tissue

NET WT 2.0 OZ (56.7 g)

Principal Display Panel - 56.7 g Tube Carton
Principal Display Panel - 56.7 g Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1372298mineral oil 14 % / petrolatum 74.9 % / phenylephrine HCl 0.25 % Rectal OintmentPSN1
1372298mineral oil 0.14 MG/MG / petrolatum 0.749 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal OintmentSCD1
1372298mineral oil 14 % / petrolatum 74.9 % / phenylephrine hydrochloride 0.25 % Rectal OintmentSY1

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37808-991-242025-01-30C16284748780-12cef2736-6e25-d83d-e063-dadaa90ab31fHEB Hemorrhoidal Ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-991-24HEB Hemorrhoidal1 in 1 CARTONCREAM11
37808-991-24HEB Hemorrhoidal56.7 g in 1 TUBECREAM56.71

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-991HEB HEMORRHOIDAL (MINERAL OIL, PETROLATUM, AND PHENYLEPHRINE HYDROCHLORIDE) CREAM [H-E-B]1Legacy NDC, 2 package rows20181026_f311c9f0-d1b1-49dc-867f-cf5eb5d15b2a.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37808-99137808-991-24

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
Mineral OilT5L8T28FGPACTIB
Petrolatum4T6H12BN9UACTIB
Phenylephrine Hydrochloride04JA59TNSJACTIB
Benzoic Acid8SKN0B0MIMIACT
White Wax7G1J5DA97FIACT
GlycerinPDC6A3C0OXIACT
Lanolin7EV65EAW6HIACT
Lanolin Alcohols884C3FA9HEIACT
MethylparabenA2I8C7HI9TIACT
ParaffinI9O0E3H2ZEIACT
PropylparabenZ8IX2SC1OHIACT
Water059QF0KO0RIACT
Thyme Oil2UK410MY6BIACT
.Alpha.-Tocopherol Acetate9E8X80D2L0IACT

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
d47d90ed-35a0-47c2-b164-f6ec9f71ab32f311c9f0-d1b1-49dc-867f-cf5eb5d15b2a2018-10-25WarningsExact identifier
spl id: d47d90ed-35a0-47c2-b164-f6ec9f71ab32
spl set id: f311c9f0-d1b1-49dc-867f-cf5eb5d15b2a

Reported adverse events (FAERS/openFDA)#

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