FDA.reportPublic FDA data

TheraCare 4% Lidocaine Cream

Manufacturer
Veridian Healthcare | Nantong Health & Beyond Hygienic Products Inc.
Effective date
2024-05-21
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:12:49

Label at a glance#

ProductTheraCare 4% Lidocaine Cream
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure7 sections

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 children 12 years or younger: ask a doctor

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl 4%

Purpose

OTC - PURPOSE SECTION

Topical anesthetic

Use

INDICATIONS & USAGE SECTION

temporarily relieves minor pain

Warnings

WARNINGS SECTION

For external use only. Avoid contact with eyes.

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 and mucus membranes
  • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center (800-222-1222) 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

children 12 years or younger: ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Alcohol, Aloe Vera Leaf, Aminomethylpropanol, Carbomer Interpolymer Type A, Cyclopentasiloxane 5, Dihexadecyl phosphate, Dimethicone, Dimethicone/Vinyl Dimethicone Crosspolymer, edetate disodium, Ethylhexylglycerin, Glyceryl monostearate, Hydroxyethyl Acrylate/ Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Phenoxyethanol, Steareth-21, Water

PRINCIPAL DISPLAY PANEL TheraCare 4% Lidocaine Cream

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1010895lidocaine HCl 4 % Topical CreamPSN3
1010895lidocaine hydrochloride 40 MG/ML Topical CreamSCD3
1010895lidocaine hydrochloride 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
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
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71101-930-01TheraCare 4% Lidocaine Cream49.6 g in 1 BOTTLE, PLASTICCREAM49.63
71101-930-01TheraCare 4% Lidocaine Cream1 in 1 CARTONCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71101-930THERACARE 4% LIDOCAINE CREAM (LIDOCAINE HYDROCHLORIDE) CREAM [VERIDIAN HEALTHCARE ]3Current NDC, Legacy NDC, 2 package rows20240522_c808aa05-9d49-cc9f-e053-2a95a90a50f3.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71101-93071101-930-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
ALCOHOL3K9958V90MIACT
ISOHEXADECANE918X1OUF1EIACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)86FQE96TZ4IACT
DIMETHICONE92RU3N3Y1OIACT
CYCLOMETHICONE 50THT5PCI0RIACT
DIHEXADECYL PHOSPHATE2V6E5WN99NIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
ALOE VERA LEAFZY81Z83H0XIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
PHENOXYETHANOLHIE492ZZ3TIACT
STEARETH-2153J3F32P58IACT
AMINOMETHYLPROPANOLLU49E6626QIACT
CARBOMER INTERPOLYMER TYPE A (55000 CPS)59TL3WG5COIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
EDETATE DISODIUM7FLD91C86KIACT

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
TheraCare 4% Lidocaine CreamLIDOCAINE HYDROCHLORIDEVeridian Healthcarec808aa05-9d49-cc9f-e053-2a95a90a50f32024-05-21WarningsExact identifier
ndc (package): 71101-930-01
ndc (product): 71101-930
ndc11 (package): 71101093001
spl id: 18fab885-9bd2-3f68-e063-6294a90a8a86
spl set id: c808aa05-9d49-cc9f-e053-2a95a90a50f3

Reported adverse events (FAERS/openFDA)#

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