MAXOCAINE Topical Anesthetic Anorectal

Manufacturer
PRIME COMMERCE, LLC | Pure Source, LLC
Effective date
2025-05-27
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:01:35

Label at a glance#

ProductMAXOCAINE Topical Anesthetic Anorectal
Active ingredientLIDOCAINE
Label structure6 sections

Dosage and administration

When practical, cleanse the affected area with mild soap and warm water, then rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before application of this product. Adults and children 12-years and over: apply externally to the affected area up to five times per day. Children under 12-years: Consult a physician.

Label contents#

Full prescribing information#

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 5.0% w/w

Purpose

OTC - PURPOSE SECTION

Topical Anesthetic

Use(s):

INDICATIONS & USAGE SECTION

For the temporary relief of pain and discomfort associated with anorectal disorders.

Warnings:

WARNINGS SECTION

  • For external use only
  • Avoid contact with eyes.
  • Do not exceed recommended daily dosage unless directed by physician.

Stop use and consult physician

OTC - STOP USE SECTION

if rectal bleeding occurs, if allergic reaction develops, if condition worsens or does not improve within seven days.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, consult physician.

Directions:

DOSAGE & ADMINISTRATION SECTION

When practical, cleanse the affected area with mild soap and warm water, then rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before application of this product.

  • Adults and children 12-years and over:apply externally to the affected area up to five times per day.
  • Children under 12-years:Consult a physician.

Other Ingredients:

INACTIVE INGREDIENT SECTION

Acrylates C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionzied Water), Arnica Montana Extract, Boswellia Serrata Extract, Cannabis Sativa (Hemp) Seed Oil, Cetyl Alcohol, Dimethicone, Ethylhexylglycerin, Ilex Paraguariensis (Yerba Mate) Extract, Isopropyl Myristate, methylsulfonylmethane (MSM), Phenoxyethanol, Polysorbate-20, Stearic Acid, Triethanolamine.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label0Label0

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72188-076-59MAXOCAINE Topical Anesthetic Anorectal59 mL in 1 JARCREAM594

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72188-076MAXOCAINE TOPICAL ANESTHETIC ANORECTAL (LIDOCAINE) CREAM [PRIME COMMERCE, LLC]4Current NDC, Legacy NDC, 1 package rows20250529_26e8c867-8cb8-4a25-91b1-da45a1edd09a.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72188-07672188-076-59

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 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
MAXOCAINE Topical Anesthetic AnorectalLIDOCAINEPRIME COMMERCE, LLC26e8c867-8cb8-4a25-91b1-da45a1edd09a2025-05-27WarningsExact identifier
ndc (package): 72188-076-59
ndc (product): 72188-076
ndc11 (package): 72188007659
spl id: 361dcf5a-5697-6935-e063-6294a90aaee1
spl set id: 26e8c867-8cb8-4a25-91b1-da45a1edd09a

Reported adverse events (FAERS/openFDA)#

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