FDA.reportPublic FDA data

Lidocaine 5% Anorectal Cream

Manufacturer
Patrin Pharma, Inc
Effective date
2024-11-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:37:48

Label at a glance#

ProductLidocaine Anorectal
Active ingredientLidocaine
Label structure10 sections

Indications and uses

Temporarily relieves pain and itching due to anorectal disorders

Dosage and administration

When practical, clean 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 room temperature 20–25°C (68–77°F); Excursions permitted 15–30°C (59–86°F) [see USP Controlled Room Temperature].

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 5% w/w

Purpose

OTC - PURPOSE SECTION

Local anesthetic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves pain and itching due to anorectal disorders

Warnings

WARNINGS SECTION

When using this product

  • Avoid contact with eyes
  • Do not exceed recommended dosage unless directed by a doctor

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • Rectal bleeding occurs
  • Condition worsens or does not improve within 7 days
  • Allergic reaction occurs
  • Redness, irritation, swelling, pain or other symptoms begin or increase
  • Symptoms clear up and return within a few days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • When practical, clean 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 room temperature 20–25°C (68–77°F); Excursions permitted 15–30°C (59–86°F) [see USP Controlled Room Temperature].

Inactive ingredients

INACTIVE INGREDIENT SECTION

Benzyl Alcohol, Carbomer, Hydrogenated Lecithin, Isopropyl Myristate, Polysorbate 80, Propylene Glycol, Purified Water, Trolamine, and Vitamin E Acetate

Questions?

OTC - QUESTIONS SECTION

Call 800-936-3088

PRINCIPAL DISPLAY PANEL - 30 gram Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 39328-025-30

Lidocaine
5%
Anorectal Cream

PATRIN
PHARMA

Net Wt. 30 grams

PRINCIPAL DISPLAY PANEL - 30 gram Tube Carton
PRINCIPAL DISPLAY PANEL - 30 gram Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1366789lidocaine 5 % Rectal CreamPSN2
1366789lidocaine 50 MG/ML Rectal CreamSCD2
1366789lidocaine 5 % Rectal CreamSY2

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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
39328-025-15Lidocaine Anorectal15 g in 1 TUBECREAM152
39328-025-15Lidocaine Anorectal1 in 1 CARTONCREAM12
39328-025-30Lidocaine Anorectal1 in 1 CARTONCREAM12
39328-025-30Lidocaine Anorectal30 g in 1 TUBECREAM302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
39328-025LIDOCAINE ANORECTAL (LIDOCAINE) CREAM [PATRIN PHARMA, INC]2Current NDC, Legacy NDC, 4 package rows20241120_456d41fe-8449-4980-9291-d7a3b65a900d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
39328-025-15GM - Gram39328-025598d8e85-60ac-4fa8-b79f-31ef3e3caaed12022-05-04
39328-025-30GM - Gram39328-02562ef8ef0-915f-4558-8efe-e60f5dd2113d12022-05-04

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
39328-02539328-025-15, 39328-025-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
Lidocaine98PI200987ACTIB
Benzyl AlcoholLKG8494WBHIACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
HYDROGENATED SOYBEAN LECITHINH1109Z9J4NIACT
Isopropyl Myristate0RE8K4LNJSIACT
Polysorbate 806OZP39ZG8HIACT
Propylene Glycol6DC9Q167V3IACT
WATER059QF0KO0RIACT
Trolamine9O3K93S3TKIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT

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
Lidocaine AnorectalLIDOCAINEPatrin Pharma, Inc456d41fe-8449-4980-9291-d7a3b65a900d2024-11-13WarningsExact identifier
ndc (package): 39328-025-15
ndc (package): 39328-025-30
ndc (product): 39328-025
ndc11 (package): 39328002515
ndc11 (package): 39328002530
spl id: 8baec15b-0d92-4e92-acd5-2c6cfa9083b9
spl set id: 456d41fe-8449-4980-9291-d7a3b65a900d

Reported adverse events (FAERS/openFDA)#

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