FDA.reportPublic FDA data

Lidocaine

Manufacturer
Nivagen Pharmaceuticals, Inc.
Effective date
2020-01-16
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:02:55

Label at a glance#

ProductLidocaine
Active ingredientLidocaine
Label structure10 sections

Indications and uses

Helps relieve the pain, itching, and burningassociated with hemorrhoids and other anorectal disorders.

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. To use finger cots: Roll one finger cot over finger. Gently squeeze cream onto finger cot....

Storage and handling

Store at 25°C (77°C); excursions permitted to 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

Helps relieve the pain, itching, and burningassociated with hemorrhoids and other anorectal disorders.

Warnings

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

When using this product

  • 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 a doctor if

OTC - STOP USE SECTION

  • rectal bleeding occurs
  • condition worsens or does not improve within 7 days
  • allergic reaction occurs to ingredients in this product
  • symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop 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, 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.
  • To use finger cots: Roll one finger cot over finger. Gently squeeze cream onto finger cot. Smooth a layer of the cream over affected area.

Other Information

STORAGE AND HANDLING SECTION

Store at 25°C (77°C); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature].

Inactive Ingredients

INACTIVE INGREDIENT SECTION

benzyl alcohol,carbomer hompolymer type C, C10-18 triglycerides, cholesterol, lecithin, isopropyl myristate, polysorbate 80, propylene glycol, tocopherol, trolamine, water

Questions?

OTC - QUESTIONS SECTION

1-877-977-0687

PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 75834-113-30

Lidocaine 5%
Anorectal Cream

Relieves:

  • Pain
  • Itching
  • Burning

NIVAGEN
PHARMACEUTICALS

net wt. 30 g (1 oz)

PRINCIPAL DISPLAY PANEL - 30 g Tube Carton
PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1366789lidocaine 5 % Rectal CreamPSN3
1366789lidocaine 50 MG/ML Rectal CreamSCD3
1366789lidocaine 5 % Rectal CreamSY3

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75834-113-302021-07-23C16284748780-1c7ccaba7-2109-fd44-e053-dadaa90aa01bLidocaine 5%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75834-113-30Lidocaine30 g in 1 TUBECREAM303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75834-113LIDOCAINE CREAM [NIVAGEN PHARMACEUTICALS, INC.]3Legacy NDC, 1 package rows20200117_47eb3395-ca44-47bd-80ce-9a31ac392a04.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75834-113-30GM - Gram75834-1139579e7a1-8fda-45b1-bb3a-718feaab425712017-05-04

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75834-11375834-113-30

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
Lidocaine98PI200987ACTIB
BENZYL ALCOHOLLKG8494WBHIACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CHOLESTEROL97C5T2UQ7JIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
POLYSORBATE 806OZP39ZG8HIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
TOCOPHEROLR0ZB2556P8IACT
TROLAMINE9O3K93S3TKIACT
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
ae5ad50d-010b-482a-8781-bab318b0df9247eb3395-ca44-47bd-80ce-9a31ac392a042026-09-02WarningsExact identifier
spl set id: 47eb3395-ca44-47bd-80ce-9a31ac392a04

Reported adverse events (FAERS/openFDA)#

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