FDA.reportPublic FDA data

Lidocaine Pain Relieving Creme

Manufacturer
Velocity Pharma LLC
Effective date
2020-09-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:30:42

Label at a glance#

ProductLidocaine Pain Relieving Creme
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure8 sections

Indications and uses

temporarily relieves minor pain 

Dosage and administration

adults and children over 12 years : apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period. After applying wash hands with soap and water. children 12 years and younger : ask a doctor

Label contents#

Full prescribing information#

Lidocaine Pain Relieving Creme

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCI 4%

Purpose

OTC - PURPOSE SECTION

Topical anesthetic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves minor pain 

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • on large areas of the body or on cut, irritated or swollen skin
  • on puncture wounds
  • for more than one week without consulting a doctor

When using this product

OTC - WHEN USING SECTION

  • use only as directed. Read and follow all directions and warnings on this carton.
  • do not allow contact with the eyes
  • do not bandage or apply local heat (such as heating pads) to the area of use

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children and pets.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children over 12 years:

  • apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period. After applying wash hands with soap and water.

children 12 years and younger: ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

butylated hydroxy toluene, cetomacrogol 1000, cetostearyl alcohol, cetyl alcohol, disodium EDTA, disodium hydrogen phosphate anhydrous, light liquid paraffin, propylene glycol,­purified water, sorbic acid, transcutol P, white petroleum jelly.

Keep Carton As It Contains Important Information

Close cap tightly between uses.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1010895lidocaine HCl 4 % Topical CreamPSN1
1010895lidocaine hydrochloride 40 MG/ML Topical CreamSCD1
1010895lidocaine hydrochloride 4 % Topical CreamSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76168-206-332022-01-28C16284748780-1d6a99b39-6271-a426-e053-dadaa90af4c2Lidocaine Pain Relieving Creme- CareOne

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76168-206-33Lidocaine Pain Relieving Creme1 in 1 CARTONCREAM11
76168-206-33Lidocaine Pain Relieving Creme133 g in 1 TUBECREAM1331

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76168-206LIDOCAINE PAIN RELIEVING CREME (LIDOCAINE HYDROCHLORIDE) CREAM [VELOCITY PHARMA LLC]1Legacy NDC, 2 package rows20201001_b090075a-9556-7a81-e053-2a95a90af2e0.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76168-20676168-206-33

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETOSTEARYL ALCOHOL2DMT128M1SIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
PARAFFINI9O0E3H2ZEIACT
CETETH-20I835H2IHHXIACT
CETYL ALCOHOL936JST6JCNIACT
EDETATE DISODIUM7FLD91C86KIACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SORBIC ACIDX045WJ989BIACT
PETROLATUM4T6H12BN9UIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
DIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BIACT

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
b0901b6b-3c79-7aa7-e053-2a95a90a626bb090075a-9556-7a81-e053-2a95a90af2e02020-09-30WarningsExact identifier
spl id: b0901b6b-3c79-7aa7-e053-2a95a90a626b
spl set id: b090075a-9556-7a81-e053-2a95a90af2e0

Reported adverse events (FAERS/openFDA)#

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