FDA.reportPublic FDA data

Quality Choice Lidocaine Cream

Manufacturer
Chain Drug Marketing Association | Weeks & Leo Co., Inc.
Effective date
2024-12-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:41:30

Label at a glance#

ProductQC Lidocaine Maximum Strength
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure11 sections

Indications and uses

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

Dosage and administration

adults and children 2 years and over: apply to affected area not more than 3 to 4 times daily children under 2 years: ask a doctor

Storage and handling

store between 20 °C and 25 °C

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl 4%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves pain and itching due to:

minor burns

sunburn

minor cuts

scrapes

insect bites

minor skin irritations

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

Do not use in large quantities, particularly over raw surfaces or blistered areas

When using this product

OTC - WHEN USING SECTION

When using this product do not get into eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

condition gets worse

symptoms last for more than 7 days

symptoms clear up and occur again within a few days

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.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 2 years and over: apply to affected area not more than 3 to 4 times daily

children under 2 years: ask a doctor

Other information

STORAGE AND HANDLING SECTION

store between 20 °C and 25 °C

Inactive ingredients

INACTIVE INGREDIENT SECTION

acrylates/C10-30 alkyl acrylate crosspolymer, aloe barbadensis (aloe vera) leaf juice, aminomethyl propanol,
C30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, dicetyl phosphate, dimethicone, edetate disodium, ethylhexylglycerin, glyceryl monostearate, methylparaben, purified water, SD alcohol 40, steareth-21

OTC - WHEN USING SECTION

do not get into eyes.

OTC - ASK DOCTOR SECTION

Conditions get worse

Symptoms last for more than 7 days or clears up and occurs again within a few days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Prinicpal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Quality Choice

Maximum Strength Lidocaine Cream Lidocaine HCL 4 %- Topical Analgesic

Steroid free, Works on Contact

CartonCarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1010895lidocaine HCl 4 % Topical CreamPSN2
1010895lidocaine hydrochloride 40 MG/ML Topical CreamSCD2
1010895lidocaine hydrochloride 4 % Topical CreamSY2

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
63868-956-01QC LidocaineMaximum Strength1 in 1 CARTONCREAM12
63868-956-01QC LidocaineMaximum Strength49.6 g in 1 BOTTLE, PLASTICCREAM49.62

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-956QC LIDOCAINE MAXIMUM STRENGTH (LIDOCAINE HCL) CREAM [CHAIN DRUG MARKETING ASSOCIATION]2Current NDC, Legacy NDC, 2 package rows20241210_b5e1b1ab-8a95-2d2d-e053-2995a90aea53.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
63868-95663868-956-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
STEARETH-2153J3F32P58IACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
DIHEXADECYL PHOSPHATE2V6E5WN99NIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETETH-20 PHOSPHATE921FTA1500IACT
ALCOHOL3K9958V90MIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
EDETATE DISODIUM7FLD91C86KIACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
ALOE VERA LEAFZY81Z83H0XIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
WATER059QF0KO0RIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
DIMETHICONE92RU3N3Y1OIACT
METHYLPARABENA2I8C7HI9TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT

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
QC Lidocaine Maximum StrengthLIDOCAINE HCLChain Drug Marketing Associationb5e1b1ab-8a95-2d2d-e053-2995a90aea532024-12-08WarningsExact identifier
ndc (package): 63868-956-01
ndc (product): 63868-956
ndc11 (package): 63868095601
spl id: 28cd8338-ad24-2cd3-e063-6394a90a4588
spl set id: b5e1b1ab-8a95-2d2d-e053-2995a90aea53

Reported adverse events (FAERS/openFDA)#

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