ASTONEA Maximum Strength Oral Pain Relief

Manufacturer
ASTONEA LABS PRIVATE LIMITED
Effective date
2024-03-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:09:24

Label at a glance#

ProductASTONEA Maximum Strength Oral Pain Relief
Active ingredientBENZOCAINE, BENZALKONIUM CHLORIDE
Label structure11 sections

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 20%

Benzalkonium Chloride 0.1%

Purpose

OTC - PURPOSE SECTION

Oral pain reliever

Antiseptic

Use

INDICATIONS & USAGE SECTION

  • for the temporary relief of pain due to toothaches
  • to help protect against infection in minor oral irritation

Warnings

WARNINGS SECTION



Methemoglobinemia warning: use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in blood. This can occur even if you have used this product before. Stop use and seek immediate medical attention if you or a child in your care develops: ■ pale, gray or blue-colored skin (cyanosis) ■ headache ■ rapid heart rate ■ shortness of breath ■ dizziness or lightheadedness ■ fatigue or lack of energy

Allergy alert:do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics

OTC - DO NOT USE SECTION

Do not use

  • more than directed
  • for more than 7 days unless directed by a physician or healthcare provider

OTC - ASK DOCTOR SECTION

Stop use and ask a physician if

  • swelling, rash or fever develops
  • irritation, pain or redness persists or worsens
  • symptoms do not improve in 7 days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN:

In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away (1-800-222-1222)

DOSAGE & ADMINISTRATION SECTION

Directions

  • Adults and children 2 years of age and over -Apply a small amount of product to the cavity and around the gum surrounding the teeth. Use up to 4 times daily or as directed by a physician or healthcare provider
  • Children under 12 years of age -Should be supervised in the use of this product
  • Children under 2 years of age- Ask a physician or healthcare provider

Other information

OTHER SAFETY INFORMATION

  • this preparation is intended for use in cases of toothache, only as a temporary expedient until a physician can be consulted
  • do not use continuously
  • avoid using toothpaste or drinking soft drinks or fruit juices for at least one hour after applying
  • do not use if tube seal under cap is broken
  • store at 20-25C (68-77F)

Inactive ingredients

INACTIVE INGREDIENT SECTION


aloe vera leaf, butylated hydroxytoluene, carbomer, cetyl alcohol, cholecalciferol, edetate disodium anhydrous, ethylhexylglycerin & phenoxyethanol, glycerol monostearate, isopropyl myristate, isopropyl palmitate, isopropyl stearate, light mineral oil, PEG 100
stearate, PEG 4000, propylene glycol, sodium benzoate, sodium hydroxide, sodium laureth sulfate, sodium metabisulfite, sodium sulfite, vitamin A palmitate, vitamin E, water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1595155benzocaine 20 % / benzalkonium chloride 0.1 % Oral GelPSN1
1595155benzalkonium chloride 0.001 MG/MG / benzocaine 0.2 MG/MG Oral GelSCD1
1595155benzalkonium chloride 0.1 % / benzocaine 20 % Oral GelSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BENZOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
77338-201-01ASTONEA Maximum Strength Oral Pain Relief1 in 1 CARTONGEL11
77338-201-01ASTONEA Maximum Strength Oral Pain Relief9.35 g in 1 TUBEGEL9.351

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
77338-201ASTONEA MAXIMUM STRENGTH ORAL PAIN RELIEF (BENZOCAINE 20%, BENZALKONIUM CHLORIDE 1%) GEL [ASTONEA LABS PRIVATE LIMITED]12 package rows20240307_12da355e-cea9-7ce3-e063-6394a90a86f1.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
77338-20177338-201-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 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
12da3e1e-9a72-762f-e063-6394a90acddb12da355e-cea9-7ce3-e063-6394a90a86f12024-03-04WarningsExact identifier
spl id: 12da3e1e-9a72-762f-e063-6394a90acddb
spl set id: 12da355e-cea9-7ce3-e063-6394a90a86f1

Reported adverse events (FAERS/openFDA)#

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