Hemorrhoidal Cream Lidocaine 5%

Manufacturer
Trifecta Pharmaceuticals Usa Llc
Effective date
2026-04-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:53:33

Label at a glance#

ProductHemorrhoidal Cream with Lidocaine
Active ingredientLIDOCAINE, WHITE PETROLATUM, GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE
Label structure22 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 cleaning wipe. Gently dry by patting or blotting with a tissue or soft cloth before applying cream. 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 Children under 12 years of age: ask a ...

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

Lidocaine 5%

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 a health professional before use

Ask a Doctor before use

OTC - ASK DOCTOR/PHARMACIST SECTION

If you 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.

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

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.

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

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

Other Information

SPL UNCLASSIFIED SECTION

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

This product is not manufactured or distributed by Haleon US Holdings LLC, distributor of Preparation H® Rapid Relief Cream

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe barbadensis leaf juice, Cetyl alcohol, Citric acid Monohydrate, Dexpanthenol, EDTA Disodium, Light mineral oil, Methylparaban,

Mono and di glycerides, Octadecyl alcohol, polysorbate 80,

Propyl 4-hydroxybenzoate,, propylene glycol, purified water, Vitamin E.

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: 4043-FBA

LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4043-FBA GLOBE HEMORRHOIDAL CREAM WITH LIDOCAINE 1OZ 031826 CDER4043-FBA GLOBE HEMORRHOIDAL CREAM WITH LIDOCAINE 1OZ 031826 CDER

LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

404303-FBA GLOBE HEMORRHOIDAL CREAM WITH LIDOCAINE 1OZ 3PK_BOX 022326 CDER404303-FBA GLOBE HEMORRHOIDAL CREAM WITH LIDOCAINE 1OZ 3PK_BOX 022326 CDER

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2642220glycerin 14.4 % / lidocaine 5 % / phenylephrine HCl 0.25 % / white petrolatum 15 % Rectal CreamPSN1
2642220glycerin 144 MG/ML / lidocaine 50 MG/ML / petrolatum 150 MG/ML / phenylephrine hydrochloride 2.5 MG/ML Rectal CreamSCD1
2642220glycerin 14.4 % / lidocaine 5 % / phenylephrine HCl 0.25 % / white petrolatum 15 % Rectal CreamSY1

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130850058161457GTIN-13: 0850058161457
EAN-13: 0850058161457
GTIN-12: 850058161457
UPC-A: 850058161457
GTIN storage (14 digits): 00850058161457
4043-FBA GLOBE HEMORRHOIDAL CREAM WITH LIDOCAINE 1OZ 031826 CDER.jpg
BarcodeEAN-130850058161464GTIN-13: 0850058161464
EAN-13: 0850058161464
GTIN-12: 850058161464
UPC-A: 850058161464
GTIN storage (14 digits): 00850058161464
404303-FBA GLOBE HEMORRHOIDAL CREAM WITH LIDOCAINE 1OZ 3PK_BOX 022326 CDER.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69396-181-01Hemorrhoidal Cream with Lidocaine28 g in 1 TUBECREAM281
69396-181-01Hemorrhoidal Cream with Lidocaine1 in 1 BOXCREAM11
69396-181-03Hemorrhoidal Cream with Lidocaine28 g in 1 TUBECREAM281
69396-181-03Hemorrhoidal Cream with Lidocaine3 in 1 BOXCREAM31

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69396-18169396-181-01, 69396-181-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 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 Cream with LidocaineGLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUMTrifecta Pharmaceuticals Usa Llc4f1ef866-c4af-989b-e063-6294a90a148e2026-04-10WarningsExact identifier
ndc (package): 69396-181-03
ndc (package): 69396-181-01
ndc (product): 69396-181
ndc11 (package): 69396018103
ndc11 (package): 69396018101
spl id: 4f1ef997-92ad-842f-e063-6294a90aab3f
spl set id: 4f1ef866-c4af-989b-e063-6294a90a148e

Reported adverse events (FAERS/openFDA)#

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