FDA.reportPublic FDA data

Lidocaine 4% Topical Anesthetic Cream

Manufacturer
Oncor Pharmaceuticals
Effective date
2026-01-05
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:31:09

Label at a glance#

ProductLidocaine 4% Topical Anesthetic Cream
Active ingredientLIDOCAINE
Label structure12 sections

Indications and uses

Temporarily relieves pain and itching due to: Minor cuts Minor scrapes Sunburn Minor burns Minor skin irritations Insect bites

Dosage and administration

Adults and children 2 years and older: apply externally to the affected area up to 3-4 times daily. Children under 2 years of age: consult a physician.

Storage and handling

Store at USP controlled room temperature 20°-25°C (68°-77°F). Manufactured In USA For : ONCOR PHARMACEUTICALS 8815 Center Park Dr Suite 430 Columbia Maryland 21045

Label contents#

Full prescribing information#

Drug Facts Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4% w/w

Purpose

OTC - PURPOSE SECTION

Topical Anesthetic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves pain and itching due to:

  • Minor cuts
  • Minor scrapes
  • Sunburn
  • Minor burns
  • Minor skin irritations
  • Insect bites

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, particularly over raw surfaces 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.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

You may report side effects by calling Oncor Pharmaceuticals (9 a.m. to 5 p.m. EST), at 1-443-876-7900 or FDA at 1-800-FDA-1088.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 2 years and older: apply externally to the affected area up to 3-4 times daily.
  • Children under 2 years of age: consult a physician.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Cetyl alcohol, Citric acid, Glycerin, Glyceryl stearate SE, Mineral oil, PEG-100 stearate, Phenoxyethanol, Purified water, Stearyl alcohol, White
petrolatum, Xanthan gum.

SPL UNCLASSIFIED SECTION

See crimp of tube or carton for lot and exp. date.

RETAIN CARTON FOR COMPLETE DRUG FACTS.

Other information

STORAGE AND HANDLING SECTION

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

Manufactured In USA For :

ONCOR PHARMACEUTICALS
8815 Center Park Dr Suite 430
Columbia
Maryland 21045

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ONCOR PHARMACEUTICALS

NDC 83720- 523-01

Lidocaine 4% Cream

Topical Anesthetic Cream

For External Use Only
Not For Ophthalmic Use

This product contains child-resistant
packaging. To open, push down on the cap of the tube while turning and lift off.

NET WT. 1.05 OZ. (30 gm)

CartonCarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1421893lidocaine 4 % Topical CreamPSN3
1421893lidocaine 40 MG/ML Topical CreamSCD3
1421893lidocaine 4 % Topical 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83720-523-01Lidocaine 4% Topical Anesthetic Cream1 in 1 CARTONCREAM13
83720-523-01Lidocaine 4% Topical Anesthetic Cream30 g in 1 TUBECREAM303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83720-523-01GM - Gram83720-523c0480993-5166-4ff2-b772-72dfae00a19712024-06-10

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83720-52383720-523-01

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
CETYL ALCOHOL936JST6JCNIACT
CITRIC ACID ACETATEDSO12WL7AUIACT
MINERAL OILT5L8T28FGPIACT
WATER059QF0KO0RIACT
WHITE PETROLATUMB6E5W8RQJ4IACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
PEG-100 STEARATEYD01N1999RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
STEARYL ALCOHOL2KR89I4H1YIACT
XANTHAN GUMTTV12P4NEEIACT
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
Lidocaine 4% Topical Anesthetic CreamLIDOCAINE 4%Oncor Pharmaceuticals1baaa669-05af-4024-a0ba-ee3451756f6a2026-01-05WarningsExact identifier
ndc (package): 83720-523-01
ndc (product): 83720-523
ndc11 (package): 83720052301
spl id: 47a797c4-ddc1-376a-e063-6294a90a469e
spl set id: 1baaa669-05af-4024-a0ba-ee3451756f6a

Reported adverse events (FAERS/openFDA)#

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