FDA.reportPublic FDA data

CVS Lidocaine HCl Cream

Manufacturer
CVS Pharmacy
Effective date
2025-12-03
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:19:25

Label at a glance#

ProductCVS Lidocaine Maximum Strength
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure8 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 (68 °F and 77 °F)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl 4%

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 SECTION

For external use only

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

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • condition gets worse
  • symptoms last for more than 7 days
  • symptoms clear up and occur again within a few days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. 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 (68 °F and 77 °F)

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display PanelPrincipal Display PanelCVS Health

Multi- Symptom Formula Works On Contact to relieve Pain & Itch From:

Minor Burns & cuts

Minor Skin Irritaions

Insect bites

Sunburns

Maximum Strength Lidocaine Cream Lidocaine HCL 4 %- Topical Analgesic

Steroid free, Works on Contact

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
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69842-921-492023-12-12C16284748780-1d6a99b39-d1ee-a426-e053-dadaa90af4c2CVS Lidocaine HCl Cream
69842-921-492022-01-28C16284748780-1d6a99b39-d1ee-a426-e053-dadaa90af4c2CVS Lidocaine HCl Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-921-49CVS LidocaineMaximum Strength1 in 1 CARTONCREAM13
69842-921-49CVS LidocaineMaximum Strength49 g in 1 BOTTLE, PLASTICCREAM493

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-92169842-921-49

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
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
CAPRYLYL METHICONEQ95M2P1KJLIACT
WATER059QF0KO0RIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
DIMETHICONE92RU3N3Y1OIACT
STEARETH-2153J3F32P58IACT
METHYLPARABENA2I8C7HI9TIACT
CETEARYL ALCOHOL2DMT128M1SIACT
CETETH-20 PHOSPHATE921FTA1500IACT
DICETYL PHOSPHATE2V6E5WN99NIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)8Z5ZAL5H3VIACT
ALOE VERA LEAFZY81Z83H0XIACT
EDETATE DISODIUM7FLD91C86KIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ALCOHOL3K9958V90MIACT
C30-45 ALKYL CETEARYL DIMETHICONE CROSSPOLYMER4ZK9VP326RIACT

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
CVS Lidocaine Maximum StrengthLIDOCAINE HCLCVS Pharmacy87490c0f-a4d9-740e-e053-2a95a90a47242025-12-03WarningsExact identifier
ndc (package): 69842-921-49
ndc (product): 69842-921
ndc11 (package): 69842092149
spl id: 45107fbf-d930-9e35-e063-6394a90aec58
spl set id: 87490c0f-a4d9-740e-e053-2a95a90a4724

Reported adverse events (FAERS/openFDA)#

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