FDA.reportPublic FDA data

ASTONEA LIDOCAINE 4 % CREAM

Manufacturer
ASTONEA LABS PRIVATE LIMITED
Effective date
2024-03-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:09:42

Label at a glance#

ProductLidocaine Pain Relief
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

temporarily relieves minor pain

Dosage and administration

adults and children 12 years and over: apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period children under 12 years: ask a doctor

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCl 4%

Purpose

OTC - PURPOSE SECTION

Lidocaine HCl - Topical anesthetic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves minor pain

Warnings

WARNINGS SECTION

For external use only

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
  • do not get into eyes
  • do not bandage tightly or apply external heat (such as a heating pad) 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
  • redness, rash, or irritation occurs

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 Poison Control Center (800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 12 years and over: apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period
  • children under 12 years: ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe vera leaf, carbomer 940, ceteth-20, cetostearyl alcohol, dimethicone, glycerin. glyceryl monostearate, isopropyl alcohol, petrolatum, phenoxyethanol, polysorbate 60, trolamine, water

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display and Drug Fact PanelPrincipal Display and Drug Fact Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1010895lidocaine HCl 4 % Topical CreamPSN1
1010895lidocaine hydrochloride 40 MG/ML Topical CreamSCD1
1010895lidocaine hydrochloride 4 % Topical CreamSY1

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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77338-009-04Lidocaine Pain Relief76.5 g in 1 TUBECREAM76.51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77338-009LIDOCAINE PAIN RELIEF (LIDOCAINE HCL) CREAM [ASTONEA LABS PRIVATE LIMITED]11 package rows20240315_137d4608-8b39-f1bf-e063-6294a90a162c.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77338-00977338-009-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISOPROPYL ALCOHOLND2M416302IACT
POLYSORBATE 60CAL22UVI4MIACT
TROLAMINE9O3K93S3TKIACT
DIMETHICONE92RU3N3Y1OIACT
ALOE VERA LEAFZY81Z83H0XIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETETH-20 PHOSPHATE921FTA1500IACT
GLYCERINPDC6A3C0OXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
WATER059QF0KO0RIACT
CARBOMER 9404Q93RCW27EIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR

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
137d58e3-83f0-c0b8-e063-6294a90a6802137d4608-8b39-f1bf-e063-6294a90a162c2024-03-12WarningsExact identifier
spl id: 137d58e3-83f0-c0b8-e063-6294a90a6802
spl set id: 137d4608-8b39-f1bf-e063-6294a90a162c

Reported adverse events (FAERS/openFDA)#

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