FDA.reportPublic FDA data

Lidocaine 3% Topical Anesthetic Cream

Manufacturer
Brookfield Pharmaceuticals, LLC
Effective date
2021-11-16
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:27:08

Label at a glance#

ProductLidocaine 3% Topical Anesthetic Cream
Active ingredientLIDOCAINE
Label structure11 sections

Indications and uses

Temporarily relieves pain and itching due to minor cuts sunburn minor scrapes minor burns insect bites minor skin irritations

Dosage and administration

Adults and children 2 years and older apply externally to the affected area up to 3 to 4 times a day Children under 2 years as a doctor

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 3% w/w

Purpose

OTC - PURPOSE SECTION

Topical anesthetic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves pain and itching due to

  • minor cuts
  • sunburn
  • minor scrapes
  • minor burns
  • insect bites
  • minor skin irritations

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

  • Do not use in or near the eyes
  • Do not use in large quantities, particularily over raw surfaces or blistered areas

Stop use and ask a doctor if

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • allergic reaction occurs
  • condition worsens or does not improve in 7 days
  • symtpoms clear up and return within a few days
  • redness, irritation, swelling, pain or other symptoms begin or increase

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If sweallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years and olderapply externally to the affected area up to 3 to 4 times a day
Children under 2 yearsas a doctor

Other information

OTHER SAFETY INFORMATION

  • May be applied under occlusive dressing.
  • Store at 20-25ºC (68-77ºF); excursions permitted to 15-30ºC (59-86ºF). See USP Controlled Room Temperature.

Inactive ingredients

INACTIVE INGREDIENT SECTION

benzyl alcohol, carbomer, lecithin, propylene glycol, purified water, triethanolamine*, vitamine E acetate.

*May contain this ingredient.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1 oz Carton1 oz Carton3 oz Carton3 oz Carton

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71351-015-01GM - Gram71351-015bb0bc81e-dda5-4f1d-a8ac-8bf36af6e4e212018-08-13
71351-015-03GM - Gram71351-015fe5cd46a-e240-4083-9971-f6aae5817f5b12018-08-13

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71351-01571351-015-01, 71351-015-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER 934Z135WT9208IACT
LECITHIN, SOYBEAN1DI56QDM62IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
LIDOCAINE98PI200987ACTIB
TROLAMINE9O3K93S3TKIACT
BENZYL ALCOHOLLKG8494WBHIACT
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
d4c40db7-c3e7-29e1-e053-2995a90ae23e7008bd3c-a014-632d-e053-2a91aa0a6d622022-01-04WarningsExact identifier
spl set id: 7008bd3c-a014-632d-e053-2a91aa0a6d62

Reported adverse events (FAERS/openFDA)#

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