hemorrhoidal

Manufacturer
Bionpharma Inc. | Galentic Pharma (India) Private Limited
Effective date
2025-03-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:58:50

Label at a glance#

Producthemorrhoidal
Active ingredientPETROLATUM, PHENYLEPHRINE HYDROCHLORIDE, MINERAL OIL
Label structure15 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

■ Adults: When practical, cleanse the affected area by patting or blotting with an appropriate cleansing pad. Gently dry by patting or blotting with toilet tissue or a soft cloth before applying ointment. ■ Apply to affected areas up to 4 times daily. ■ EXTERNAL USE: Apply to affected area ■ FOR INTRARECTAL USE: ■ Remove cover from the applicator ■ Attach applicator to tube ■ Lubricate applicator well, then gently...

Storage and handling

■ Store at 15°C – 30°C (59°F – 86°F) ■ Lot No. & Expiry Date: See box or crimp of tube

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Mineral Oil 14%

Petrolatum 74.9%

Phenylephrine HCI 0.25%

Purpose

OTC - PURPOSE SECTION

Protectant

Protectant

Vasoconstrictor

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 a doctor before use if you have

OTC - ASK DOCTOR SECTION

■ heart disease ■ high blood pressure ■ thyroid disease ■ diabetes
■ difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you

OTC - ASK DOCTOR/PHARMACIST SECTION

are 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 doctor if

OTC - STOP USE SECTION

■ condition worsens or does not improve within 7 days ■ bleeding occurs

■ introduction of applicator into the rectum causes additional pain

If pregnant or breast- feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional 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: When practical, cleanse the affected area by patting or blotting with an appropriate cleansing pad. Gently dry by patting or blotting with toilet tissue or a soft cloth before applying ointment.
■ Apply to affected areas up to 4 times daily.
■ EXTERNAL USE: Apply to affected area
■ FOR INTRARECTAL USE: ■ Remove cover from the applicator ■ Attach applicator to tube ■ Lubricate applicator well, then gently insert applicator into the rectum ■ Thoroughly clean applicator after each use and replace cover
■ Children under 12 years of age: consult a doctor

Other information

STORAGE AND HANDLING SECTION

■ Store at 15°C – 30°C (59°F – 86°F)
■ Lot No. & Expiry Date: See box or crimp of tube

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzoic acid, butylated hydroxyanisole, corn oil, glycerin, lanolin, lanolin alcohols, methylparaben, mineral oil, paraffin, propylparaben, purified water, thyme oil, vitamin E, white wax

SPL UNCLASSIFIED SECTION

READ AND KEEP CARTON FOR COMPLETE INFORMATION

*This product is not manufactured or distributed by the owners of Preparation H® Hemorrhoidal Ointment.

Manufactured for: Bionpharma Inc., Princeton, NJ 08540

GUJ/DRUGS/G/25/2134

MADE IN INDIA

L0000812

R0424

LOT & EXP.

tube carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

*compare to the active ingredient in Preparation H ® Hemorrhoid Treatment Ointment

NDC 69452-448-38

a+ health TM

hemorrhoidal ointment

• reduces irritation • with applicator

dye-free • phthalate-free • fragrance-free

• relieves both internal and external hemorrhoid symptoms
• temporarily shrinks swollen hemorrhoidal tissue
• prompt, soothing relief from painful burning, itching and discomfort

net wt. 2 oz

image001image001

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
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
69452-448-38hemorrhoidal56 g in 1 TUBEOINTMENT561
69452-448-38hemorrhoidal1 in 1 CARTONOINTMENT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69452-448HEMORRHOIDAL (MINERAL OIL, PETROLATUM, PHENYLEPHRINE HCL) OINTMENT [BIONPHARMA INC.]1Current NDC, 2 package rows20250410_1790da99-2a22-e2a2-e063-6394a90ac36f.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69452-44869452-448-38

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

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
hemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLBionpharma Inc.1790da99-2a22-e2a2-e063-6394a90ac36f2025-03-31WarningsExact identifier
ndc (package): 69452-448-38
ndc (product): 69452-448
ndc11 (package): 69452044838
spl id: 1790da99-2a23-e2a2-e063-6394a90ac36f
spl set id: 1790da99-2a22-e2a2-e063-6394a90ac36f

Reported adverse events (FAERS/openFDA)#

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