FDA.reportPublic FDA data

Lidocaine Anesthetic Cream - Nationwide Pharmaceutical LLC

Manufacturer
Nationwide Pharmaceutical LLC
Effective date
2026-09-11
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
daily-update
Hydrated at
2026-09-15 03:02:22

Label at a glance#

ProductLidocaine Anesthetic Cream
Active ingredientLIDOCAINE
Label structure9 sections

Indications and uses

For temporary relief of pain associated with minor cuts, minor burns, minor scrapes, sunburn, minor skin irritations, and insect bites.

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 of age. Consult a doctor.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4% w/w

Purpose

OTC - PURPOSE SECTION

Local Anesthetic

Uses

INDICATIONS & USAGE SECTION

For temporary relief of pain associated with minor cuts, minor burns, minor scrapes, sunburn, minor skin irritations, and insect bites.

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

  • do not get into eyes.
  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not use in large quantities, particularly over raw or blistered areas.

Stop use and ask a doctor if

OTC - ASK DOCTOR SECTION

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

If pregnant or breastfeeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Drug Facts (continued)

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 of age. Consult a doctor.

Other Information

HEALTH CLAIM SECTION

Store at USP controlled room temperature 20-25 °C (68-77 °F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

Benzyl Alcohol, Carbomer, Cholesterol, Hydrogenated Lecithin, Isopropyl Myristate, Polysorbate 80, Propylene Glycol, Purified Water, Triethanolamine, Vitamin E Acetate.

Questions?

SPL UNCLASSIFIED SECTION

1-800-697-3329

PRINCIPAL DISPLAY PANEL - 28 g Tube Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Nationwide
Pharmaceutical

NDC 69375-005-30

4% Lidocaine
Topical Anesthetic Cream

NET WT 1 oz (28 g)

PRINCIPAL DISPLAY PANEL - 28 g Tube Box Nationwide Pharmaceutical NDC 69375-005-30 4% Lidocaine Topical Anesthetic Cream NET WT 1 oz (28 g)PRINCIPAL DISPLAY PANEL - 28 g Tube Box Nationwide Pharmaceutical NDC 69375-005-30 4% Lidocaine Topical Anesthetic Cream NET WT 1 oz (28 g)

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69375-005-302024-01-31C16284748780-11030e365-4ceb-111a-e063-dadaa90a10e2Lidocaine Cream
69375-005-302024-01-31C16284748780-11030e365-4ceb-111a-e063-dadaa90a10e2Drug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69375-005-30GM - Gram69375-00511618954-a617-405b-94c8-2c5c073600db12022-07-06

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69375-00569375-005-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE98PI200987ACTIB
BENZYL ALCOHOLLKG8494WBHIACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
CHOLESTEROL97C5T2UQ7JIACT
HYDROGENATED SOYBEAN LECITHINH1109Z9J4NIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
POLYSORBATE 806OZP39ZG8HIACT
TROLAMINE9O3K93S3TKIACT
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42025-06-05full-release2026-06-01 01:02:15

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
a33884fe-a746-445f-8cf9-492c11ada45adcc5a175-97a0-4e5f-a74d-1a7059d0bfff2025-06-05WarningsExact identifier
spl set id: dcc5a175-97a0-4e5f-a74d-1a7059d0bfff

Reported adverse events (FAERS/openFDA)#

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