Maximum Strength Hemorrhoidal Cream with Aloe

Manufacturer
Chain Drug Marketing Association | Trifecta Pharmaceuticals USA | Zhejiang Jingwei Pharmaceutical Co., Ltd.
Effective date
2025-07-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:06:45

Label at a glance#

ProductMaximum Strength Hemorrhoidal Cream with Aloe
Active ingredientWHITE PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, GLYCERIN
Label structure19 sections

Indications and uses

For temporary relief of pain, soreness and burning. Helps relieve the local itching and discomfort associated with hemorrhoids Temporarily shrinks hemorrhoidal tissue. 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, 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 cream. When first opening the tube, remove the foil seal. Apply externally or in the lower portion of the anal canal only Apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each b...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Glycerin 14.4%

Purpose

OTC - PURPOSE SECTION

Protectant

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Phenylephrine HCI 0.25%

Purpose

OTC - PURPOSE SECTION

Vasoconstrictor

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Pramoxine HCI 1%

Purpose

OTC - PURPOSE SECTION

Local Anesthetic

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

White Petrolatum 15%

Purpose

OTC - PURPOSE SECTION

Protectant

Uses

INDICATIONS & USAGE SECTION

For temporary relief of pain, soreness and burning.

Helps relieve the local itching and discomfort associated with hemorrhoids

Temporarily shrinks hemorrhoidal tissue.

Temporarily provides a coating for relief of anorectal discomforts

Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

Stop use and ask a doctor

OTC - STOP USE SECTION

Bleeding occurs

Condition worsens or does not improve within 7 days

An allergic reaction develops

The symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase

If Pregnant or Breast Feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask 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:

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 cream.

When first opening the tube, remove the foil seal.

Apply externally or in the lower portion of the anal canal only

Apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement

For application in the lower anal canal; remove cover from applicator. Attach applicator to tube. Lubricate applicator well, then gently insert applicator pathway into anus.

Thoroughly cleanse applicator after each use and replace cover.

Children under 12 years of age: ask a doctor

Warnings

WARNINGS SECTION

For External Use Only

Ask doctor brfore 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 arepresently taking a prescription for high blood pressure or depression

When using this product

Do not exceed the recommended daily dosage unless directed by a doctor

Do not put into the rectum by using fingers or any mechanical device or applicator

Other Information

SPL UNCLASSIFIED SECTION

Store at room temperature 20º-25ºC (68º-77ºF)

This product is not manufactured or distributed by Pfizer Consumer Healthcare, owner of the registered trademark Preparation H®

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe barbadensis leaf juice, carboxmethylcellulose sodium, cetearyl alcohol, mono and diglycerides, methylparaben, light mineral oil, polysorbate 80, propylene glycol, propylparaben, purified water, stearic acid, xanthan gum

Questions or Comments

OTC - QUESTIONS SECTION

Call 1-800-935-2362

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

99125 QC HEMORRHOIDAL CREAM WITH ALOE 0.9OZ REV04 062525 JW CDER99125 QC HEMORRHOIDAL CREAM WITH ALOE 0.9OZ REV04 062525 JW CDER

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1293649glycerin 14.4 % / phenylephrine HCl 0.25 % / pramoxine HCl 1 % / white petrolatum 15 % Rectal CreamPSN1
1293649glycerin 144 MG/ML / petrolatum 150 MG/ML / phenylephrine hydrochloride 2.5 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal CreamSCD1
1293649glycerin 14.4 % / phenylephrine hydrochloride 0.25 % / pramoxine hydrochloride 1 % / white petrolatum 15 % Rectal CreamSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GLYCERIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
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
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83324-330-01Maximum Strength Hemorrhoidal Cream with Aloe1 in 1 BOXCREAM11
83324-330-01Maximum Strength Hemorrhoidal Cream with Aloe25.5 g in 1 TUBECREAM25.51

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83324-33083324-330-01

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
Maximum Strength Hemorrhoidal Cream with AloeGLYCERIN, PHENYLEPHINE HCI, PRAMOXINE HCI, PETROLATUMChain Drug Marketing Association396ea654-8be1-591a-e063-6294a90a11e22025-07-08WarningsExact identifier
ndc (package): 83324-330-01
ndc (product): 83324-330
ndc11 (package): 83324033001
spl id: 396ea66c-b1c7-c3fb-e063-6394a90aaeb1
spl set id: 396ea654-8be1-591a-e063-6294a90a11e2

Reported adverse events (FAERS/openFDA)#

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