Lidonex

Manufacturer
Newpharma, Inc.
Effective date
2024-02-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:09:18

Label at a glance#

ProductLidonex
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure11 sections

Storage and handling

avoid storing prouct in direct sunlight prodect product from excessive moisture store with lid closed tightly

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Lidocaine HCL, USP 4% 

OTC - PURPOSE SECTION

Purpose

Topical Anesthetic

INDICATIONS & USAGE SECTION

Use

For temporarily relief of pain

WARNINGS SECTION

Warnings

For external use only

Flammable: Keep away from fire or flame

Do not use

  • on wounds or damaged skin
  • in large quantaties
  • with a heating pad
  • if you are allergic to any ingredients of this product

When using this product

  • use only as directed. 
  • avoid contact with the eyes, mucous membranes or rashes
  • do not bandage tightly 

Stop use and ask doctor if

  • skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
  • condition worsens
  • symptoms persist for more than 7 days 
  • symptoms clear up and occur again within a few days

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.

DOSAGE & ADMINISTRATION SECTION

Directions

Adults and children over 12 years of age and over

  • clean and dry affected area
  • apply to affected area not more than 3 to 4 times daily

Children under 12 years of age: Consult a doctor

INACTIVE INGREDIENT SECTION

Inactive ingredients

glycerin, isopropyl alcohol, menthol, methylparaben, propylparaben, purified water, xanthan gum

STORAGE AND HANDLING SECTION

  • avoid storing prouct in direct sunlight
  • prodect product from excessive moisture
  • store with lid closed tightly

OTC - QUESTIONS SECTION

Questions or comments? (305) 592 - 9216

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LidonexLidonex

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1987647lidocaine hydrochloride 4 % Topical SolutionPSN2
1987647lidocaine hydrochloride 40 MG/ML Topical SolutionSCD2
1987647lidocaine hydrochloride 4 % Topical SolutionSY2

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73564-800-022024-03-01C16284748780-11030e365-2d96-111a-e063-dadaa90a10e2ea39cd13-cacf-3d69-e053-2995a90a7906
73564-800-022024-01-30C16284748780-11030e365-2d96-111a-e063-dadaa90a10e2ea39cd13-cacf-3d69-e053-2995a90a7906

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73564-800-02Lidonex60 mL in 1 BOTTLELIQUID602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73564-800LIDONEX (LIDOCAINE HCL) LIQUID [NEWPHARMA, INC.]2Legacy NDC, 1 package rows20240302_ea39cd13-cacf-3d69-e053-2995a90a7906.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73564-80073564-800-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

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
128b9fee-105c-d708-e063-6294a90af495ea39cd13-cacf-3d69-e053-2995a90a79062024-02-29WarningsExact identifier
spl id: 128b9fee-105c-d708-e063-6294a90af495
spl set id: ea39cd13-cacf-3d69-e053-2995a90a7906

Reported adverse events (FAERS/openFDA)#

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