FDA.reportPublic FDA data

ASTONEA Burn Cream

Manufacturer
ASTONEA LABS PRIVATE LIMITED
Effective date
2023-05-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:54:58

Label at a glance#

ProductASTONEA Burn Cream
Active ingredientLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE
Label structure12 sections

Indications and uses

For temporary relief of pain and itching associated with: Sunburn Minor burns, Insect bites, Minor skin irritation, Cuts Scrapes

Dosage and administration

Adults and children 2 years and over: clean the affected area apply a small amount of this product on the area 3 or 4 times daily. may be covered with a sterile bandage Children under 2 years consult a doctor

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCL 0.5% Topical Analgesic

Benzalkonium Chloride 0.13% Topical Antiseptic

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Topical Antiseptic

Uses

INDICATIONS & USAGE SECTION

For temporary relief of pain and itching associated with:

  • Sunburn
  • Minor burns,
  • Insect bites,
  • Minor skin irritation,
  • Cuts
  • Scrapes

Warnings

WARNINGS SECTION

FOR EXTERNAL USE ONLY

Do Not Use

OTC - DO NOT USE SECTION

Do Not Use:

  • In the eyes
  • Over large areas of the body or on deep puncture wounds, animal bites or serious burns.
  • In large quantities, particularly over raw surfaces or blistered areas.

Stop Use

OTC - STOP USE SECTION

•the condition gets worse •condition clears up and recurs within a few days •condition persists for more than 7 days

If pregnant or breast feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health care professional before use.

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:

  • clean the affected area
  • apply a small amount of this product on the area 3 or 4 times daily.
  • may be covered with a sterile bandage

Children under 2 years

  • consult a doctor

Other Information

SPL UNCLASSIFIED SECTION

•store in a cool, dry area 59°-86°F (15°-30°C) •tamper evident sealed packets do not use any opened or torn packets

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe barbadensis leaf juice, Cetearyl alcohol, Disodium EDTA, Ethylhexylglycerin, Glycerin, Glyceryl stearate/PEG-100 stearate, Maltodextrin, Mineral oil, Phenoxyethanol, Propylene glycol, Purified water, Stearic acid, Triethanolamine.

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
1012100benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical CreamPSN1
1012100benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical CreamSCD1
1012100benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % 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
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
77338-100-012025-01-30C16284748780-12cef2736-7654-d83d-e063-dadaa90ab31fASTONEA Burn Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77338-100-01ASTONEA Burn Cream0.9 g in 1 PACKETCREAM0.91

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77338-100ASTONEA BURN CREAM (LIDOCAINE) CREAM [ASTONEA LABS PRIVATE LIMITED]11 package rows20230517_fbd4a1c0-6036-cc8f-e053-6394a90a1e91.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77338-10077338-100-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERYL STEARATE/PEG-100 STEARATERD25J5V947IACT
MALTODEXTRIN7CVR7L4A2DIACT
PHENOXYETHANOLHIE492ZZ3TIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
MINERAL OILT5L8T28FGPIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
STEARIC ACID4ELV7Z65APIACT
TROLAMINE9O3K93S3TKIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB

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
fbd4bf16-e141-9ecd-e053-6294a90a5b2cfbd4a1c0-6036-cc8f-e053-6394a90a1e912023-05-16WarningsExact identifier
spl id: fbd4bf16-e141-9ecd-e053-6294a90a5b2c
spl set id: fbd4a1c0-6036-cc8f-e053-6394a90a1e91

Reported adverse events (FAERS/openFDA)#

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