RectaEase Hemorrhoid Relief Cream

Manufacturer
Trifecta Pharmaceuticals USA LLC
Effective date
2026-07-20
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
daily-update
Hydrated at
2026-07-23 05:10:03

Label at a glance#

ProductRectaEase Hemorrhoid Relief Cream
Active ingredientLIDOCAINE
Label structure16 sections

Indications and uses

Helps relieve the pain, ithcing and burning associated with hemorrhoids and other anorectal disorders.

Dosage and administration

Directions: When practical, clean the affected area with mild soaping warm water and rinse thoroughly. Gently dry by patting or blotting with a toilet tissue or soft cloth before applying. Adult and children 12 years of age and older, apply to affected area not more than 6 times a day. Children under 12 years of age: do not use, ask a doctor

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 5% w/w

Purpose

OTC - PURPOSE SECTION

Local Anesthetic

Uses

INDICATIONS & USAGE SECTION

Helps relieve the pain, ithcing and burning associated with hemorrhoids and other anorectal disorders.

Warning Section

WARNINGS SECTION

For External Use Only

Stop use and ask a doctor

OTC - STOP USE SECTION

Rectal bleeding occurs

Condition worsens

Symptoms persist for more than 7 days or clear up and return within a few days

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

When using this product

OTC - WHEN USING SECTION

Avoid contact with the eyes

do not use more than directed unless told to do so by a doctor

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

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

Directions:

When practical, clean the affected area with mild soaping warm water and rinse thoroughly.

Gently dry by patting or blotting with a toilet tissue or soft cloth before applying.

Adult and children 12 years of age and older, apply to affected area not more than 6 times a day.

Children under 12 years of age: do not use, ask a doctor

Other Information

SPL UNCLASSIFIED SECTION

Store at 20º-25ºC (68º-77ºF)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Benzyl alcohol, Carbomer 940, Cholesterol, Hydrogenated Lecithin, Isopropyl myristate, Propylene glycol,Trolamine, Vitamin E, polysorbate 80, propylene glycol, purified water

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

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4074 RECTAEASE HEMORRHID RELIEF CREAM WITH 5 PERCENT LIDOCAINE 1OZ NO FINGER COTS CDER 24074 RECTAEASE HEMORRHID RELIEF CREAM WITH 5 PERCENT LIDOCAINE 1OZ NO FINGER COTS CDER 24074 RECTAEASE HEMORRHID RELIEF CREAM WITH 5 PERCENT LIDOCAINE 1OZ NO FINGER4074 RECTAEASE HEMORRHID RELIEF CREAM WITH 5 PERCENT LIDOCAINE 1OZ NO FINGER

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Recta east Hemorrhoidal Relief Cream 1oz 3pk_box CDER 120125Recta east Hemorrhoidal Relief Cream 1oz 3pk_box CDER 120125

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Recta ease Hemorrhoidal Relief Cream 1oz 2pk_box CDER 120125Recta ease Hemorrhoidal Relief Cream 1oz 2pk_box CDER 120125Recta ease Hemorrhoidal Relief Cream 1oz 3pk_box CDER 120125Recta ease Hemorrhoidal Relief Cream 1oz 3pk_box CDER 120125

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130860003665770GTIN-13: 0860003665770
EAN-13: 0860003665770
GTIN-12: 860003665770
UPC-A: 860003665770
GTIN storage (14 digits): 00860003665770
4074 RECTAEASE HEMORRHID RELIEF CREAM WITH 5 percent LIDOCAINE 1OZ NO FINGER CO....jpg
Data codeCode 128X0032F9KM5Recta ease Hemorrhoidal Relief Cream 1oz 2pk_box CDER 120125.jpg
Data codeCode 128X003F7469RRecta ease Hemorrhoidal Relief Cream 1oz 3pk_box CDER 120125.jpg

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69396-07069396-070-01, 69396-070-22, 69396-070-33

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62026-03-04full-release2026-06-01 01:48:55
52025-12-08monthly-update2026-06-03 17:53:11

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
RectaEase Hemorrhoid Relief CreamLIDOCAINETrifecta Pharmaceuticals USA LLCc054921a-9f1b-7c75-e053-2995a90a17382026-07-20WarningsExact identifier
ndc (package): 69396-070-01
ndc (package): 69396-070-22
ndc (package): 69396-070-33
ndc (product): 69396-070
ndc11 (package): 69396007022
ndc11 (package): 69396007033
ndc11 (package): 69396007001
spl id: 57165430-c79f-2013-e063-6294a90a03be
spl set id: c054921a-9f1b-7c75-e053-2995a90a1738

Reported adverse events (FAERS/openFDA)#

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