Hemorrhoidal Cream

Manufacturer
Trifecta Pharmaceuticals Usa Llc
Effective date
2025-07-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:11:34

Label at a glance#

ProductHemorrhoidal Cream
Active ingredientPRAMOXINE HYDROCHLORIDE, PETROLATUM, GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure21 sections

Indications and uses

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 Temporary relief of pain, soreness and burning

Dosage and administration

Adults: When practical, clean the affected area by patting or blotting with an appropriate cleaning wipe. Gently dry by patting or blotting with a tissue or soft cloth before applying cream. When first opening 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 mo...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Glycerol 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

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

Temporary relief of pain, soreness and burning

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 cleaning wipe. Gently dry by patting or blotting with a tissue or soft cloth before applying cream.

When first opening 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 the anus.

Thoroughly clense 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

Thyroid Disease

Diabetes

thyroid disease

Difficulty urinating due to enlargement of 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)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Questions or Comments

OTC - QUESTIONS SECTION

Call 1-888-296-9067

Distributed By

SPL UNCLASSIFIED SECTION

Trifecta Pharmaceuticals USA™

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301, USA

1-888-296-9067

www.trifecta-pharma.com

SKU: 430903-FBA

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

Do not use if tube seal under cap is broken or missing.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

403903-FBA GLOBE HEMORRHOIDAL CREAM WITH ALOE 1.8OZ 3PK_BOX 062025-JW CDER403903-FBA GLOBE HEMORRHOIDAL CREAM WITH ALOE 1.8OZ 3PK_BOX 062025-JW CDER

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

430902-FBA GLOBE HEMORRHOIDAL CREAM WITH ALOE 1.8OZ 2PK_BOX 080625-JW CDER430902-FBA GLOBE HEMORRHOIDAL CREAM WITH ALOE 1.8OZ 2PK_BOX 080625-JW CDER

LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4309 GLOBE HEMORRHOIDAL CREAM WITH ALOE 1.8OZ 080625-JW-CDER4309 GLOBE HEMORRHOIDAL CREAM WITH ALOE 1.8OZ 080625-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 CreamPSN2
1293649glycerin 144 MG/ML / petrolatum 150 MG/ML / phenylephrine hydrochloride 2.5 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal CreamSCD2
1293649glycerin 14.4 % / phenylephrine hydrochloride 0.25 % / pramoxine hydrochloride 1 % / white petrolatum 15 % Rectal CreamSY2

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
69396-171-18Hemorrhoidal Cream1 in 1 BOXCREAM12
69396-171-18Hemorrhoidal Cream51 g in 1 TUBECREAM512
69396-171-22Hemorrhoidal Cream51 g in 1 TUBECREAM512
69396-171-22Hemorrhoidal Cream2 in 1 BOXCREAM22
69396-171-33Hemorrhoidal Cream3 in 1 BOXCREAM32
69396-171-33Hemorrhoidal Cream51 g in 1 TUBECREAM512

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
69396-17169396-171-33, 69396-171-22, 69396-171-18

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
Hemorrhoidal CreamGLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUMTrifecta Pharmaceuticals Usa Llc38cf4e43-280b-eb96-e063-6294a90a59492025-07-02WarningsExact identifier
ndc (package): 69396-171-18
ndc (package): 69396-171-33
ndc (package): 69396-171-22
ndc (product): 69396-171
ndc11 (package): 69396017133
ndc11 (package): 69396017118
ndc11 (package): 69396017122
spl id: 38f270f2-cff5-fa96-e063-6294a90ae256
spl set id: 38cf4e43-280b-eb96-e063-6294a90a5949

Reported adverse events (FAERS/openFDA)#

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