FDA.reportPublic FDA data

Leader Lidocaine

Manufacturer
CARDINAL HEALTH | Weeks & Leo Co., Inc.
Effective date
2025-12-03
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:19:31

Label at a glance#

ProductLeader Lidocaine
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure9 sections

Dosage and administration

adults and children 12 years and over: apply to affected area not more than 3 to 4 times daily children under 12 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

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

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

GENERAL PRECAUTIONS SECTION

Flammable •Keep away from fire or flame

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use

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 12 years and over: apply to affected area not more than 3 to 4 times daily
  • children under 12 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

OTC - QUESTIONS SECTION

call 515-276-1586

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

65-306-31v3.0 Carton65-306-31v3.0 CartonLeader

NDC 70000-0099-1

Maximum Strength

Lidocaine

Pain Relief

Liquid

Lidocaine HCl, 4% Topical Analgesic

No Mess

Applicator

Compare to

Aspercreme

Lidocaine liquid

active ingredient

100% Money Back Guarantee

2.5 Fl oz (73 mL)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1987647lidocaine hydrochloride 4 % Topical SolutionPSN4
1987647lidocaine hydrochloride 40 MG/ML Topical SolutionSCD4
1987647lidocaine hydrochloride 4 % Topical SolutionSY4

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
70000-0099-1Leader Lidocaine1 in 1 CARTONLIQUID14
70000-0099-1Leader Lidocaine73 mL in 1 BOTTLE, PLASTICLIQUID734

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0099-1ML - Milliliter70000-0099de98e562-a99d-4124-a7b5-4117fc18f92a12023-02-06

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-009970000-0099-1

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
GLYCERYL MONOSTEARATE230OU9XXE4IACT
AMINOMETHYLPROPANOLLU49E6626QIACT
CETETH-20 PHOSPHATE921FTA1500IACT
STEARETH-2153J3F32P58IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
METHYLPARABENA2I8C7HI9TIACT
DICETYL PHOSPHATE2V6E5WN99NIACT
DIMETHICONE 3502Y53S6ATLUIACT
ALCOHOL3K9958V90MIACT
ALOE VERA LEAFZY81Z83H0XIACT
CETEARYL ALCOHOL2DMT128M1SIACT
EDETATE DISODIUM7FLD91C86KIACT
WATER059QF0KO0RIACT
CAPRYLYL METHICONEQ95M2P1KJLIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)8Z5ZAL5H3VIACT
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
Leader LidocaineLIDOCAINE HCLCARDINAL HEALTHcece6765-0e2f-5ce9-e053-2995a90a37582025-12-03WarningsExact identifier
ndc (package): 70000-0099-1
ndc (product): 70000-0099
ndc11 (package): 70000009901
spl id: 4510206b-2fb1-34d9-e063-6294a90af3cc
spl set id: cece6765-0e2f-5ce9-e053-2995a90a3758

Reported adverse events (FAERS/openFDA)#

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