FDA.reportPublic FDA data

Lidocaine

Manufacturer
Nivagen Pharmaceuticals, Inc. | Westwood Laboratories, LLC
Effective date
2025-11-03
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
monthly-update
Hydrated at
2026-06-03 17:38:47

Label at a glance#

ProductLidocaine
Active ingredientLIDOCAINE
Label structure10 sections

Indications and uses

Temporarily relieves the pain and itching due to 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.

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

Topical anesthetic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves the pain and itching due to anorectal disorders.

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes
  • do not use in large quantities, particularly over large surfaces or blistered areas
  • 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.

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 75834-141-30

Lidocaine 5%
Topical Anesthetic Cream-Anorectal

NIVAGEN
PHARMACEUTICALS

net wt. 30 g (1 oz)

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130375834141305GTIN-13: 0375834141305
EAN-13: 0375834141305
GTIN-12: 375834141305
UPC-A: 375834141305
GTIN storage (14 digits): 00375834141305		lidocaine-01.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75834-141-302021-09-22C16284748780-19d75b9d0-16a5-f424-e053-dadaa90a57ceNIV35-Lidocaine 5%
75834-141-302021-07-23C16284748780-19d75b9d0-16a5-f424-e053-dadaa90a57ceNIV35-Lidocaine 5%
75834-141-302020-04-20C16284748780-19d75b9d0-16a5-f424-e053-dadaa90a57ceNIV35-Lidocaine 5%
75834-141-302020-01-31C16284748780-19d75b9d0-16a5-f424-e053-dadaa90a57ceNIV35-Lidocaine 5%

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75834-141-30GM - Gram75834-14116ead4a9-de70-4cea-bb3d-5c34e4d2fd1112018-03-08

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
75834-14175834-141-30

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
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
LIDOCAINE98PI200987ACTIB

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
42b6b5fb-7eb0-4368-e063-6294a90aab70e4565a04-1304-4f87-8d40-8a4ff72125ae2025-11-03WarningsExact identifier
spl id: 42b6b5fb-7eb0-4368-e063-6294a90aab70
spl set id: e4565a04-1304-4f87-8d40-8a4ff72125ae

Reported adverse events (FAERS/openFDA)#

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