Lidocaine 5% Topical Anorectal Cream

Manufacturer
Mohnark Pharmaceuticals Inc.
Effective date
2025-05-13
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:01:00

Label at a glance#

ProductLidocaine 5% Topical Anorectal Cream
Active ingredientLIDOCAINE
Label structure12 sections

Dosage and administration

when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying. Adults and children 12 years and older: apply externally to the affected area up to 6 times a day. Children under 12 years of age: consult a doctor.

Storage and handling

Store at USP controlled room temperature 20-25 o C (68-77 o F).

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 5% w/w

Purpose

OTC - PURPOSE SECTION

Local Anesthetic

Uses

helps relieves pain, itching and burning associated with hemorrhoids and other anorectal disorders

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes
  • do not exceed recommended dosage unless directed by a doctor
  • do not put this product into the rectum by using fingers or any mechanical device or applicator

Stop use and ask doctor if

OTC - ASK DOCTOR SECTION

  • rectal bleeding occurs
  • condition worsens or does not improve within 7 days
  • allergic reaction occurs
  • symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase
  • symptoms clear up and return in a few days

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

INSTRUCTIONS FOR USE SECTION

  • when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying.
  • Adults and children 12 years and older: apply externally to the affected area up to 6 times a day.
  • Children under 12 years of age: consult a doctor.

Other information

STORAGE AND HANDLING SECTION

  • Store at USP controlled room temperature 20-25 oC (68-77 oF).

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzyl alcohol, carbomer 940, cholesterol, hydrogenated lecithin, polysorbate 80, propylene glycol, tocopheryl acetate, trolamine, water.

Dosage

DOSAGE & ADMINISTRATION SECTION

50 milligrams/gram per application

Usage

INDICATIONS & USAGE SECTION

  • Adults and children 2 years and older: apply externally to the affected area up to 3-4 times a day.
  • Children under 2 years of age: consult a doctor

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5% Lidocaine cream5% Lidocaine cream

DailyMed Pharmacologic Classes#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73715-002-01Lidocaine 5% Topical Anorectal Cream30 g in 1 TUBECREAM305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73715-002LIDOCAINE 5% TOPICAL ANORECTAL CREAM CREAM [MOHNARK PHARMACEUTICALS INC.]5Legacy NDC, 1 package rows20250515_a7205326-18dc-2ebb-e053-2995a90a8312.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73715-00273715-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYSORBATE 806OZP39ZG8HIACT
LIDOCAINE98PI200987ACTIB
WATER059QF0KO0RIACT

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
35108317-a593-21a3-e063-6294a90ac50ba7205326-18dc-2ebb-e053-2995a90a83122025-05-13WarningsExact identifier
spl id: 35108317-a593-21a3-e063-6294a90ac50b
spl set id: a7205326-18dc-2ebb-e053-2995a90a8312

Reported adverse events (FAERS/openFDA)#

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