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#
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredients
Benzocaine 20%
Benzalkonium Chloride 0.1%
Purpose
Oral pain reliever
Antiseptic
Use
- for the temporary relief of pain due to toothaches
- to help protect against infection in minor oral irritation
Warnings
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
- 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
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
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| BENZOCAINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 60c52429-fcef-eb54-2387-43bc9e4f296b | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 77338-201-01 | ASTONEA Maximum Strength Oral Pain Relief | 1 in 1 CARTON | GEL | 1 | 1 | |
| 77338-201-01 | ASTONEA Maximum Strength Oral Pain Relief | 9.35 g in 1 TUBE | GEL | 9.35 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- ASTONEA Maximum Strength Oral Pain Relief
- Benzocaine 20%, Benzalkonium Chloride 1%
- GLYCERYL MONOSTEARATE
- ISOPROPYL MYRISTATE
- PHENOXYETHANOL
- ISOPROPYL PALMITATE
- ISOPROPYL STEARATE
- WATER
- ALOE VERA LEAF
- BUTYLATED HYDROXYTOLUENE
- CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
- CETYL ALCOHOL
- CHOLECALCIFEROL
- EDETATE DISODIUM
- BENZOCAINE
- BENZALKONIUM CHLORIDE
- BENZALKONIUM
- ETHYLHEXYLGLYCERIN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 77338-201 | 77338-201-01 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 12da3e1e-9a72-762f-e063-6394a90acddb | 12da355e-cea9-7ce3-e063-6394a90a86f1 | 2024-03-04 | Warnings | 12da3e1e-9a72-762f-e063-6394a90acddb 12da355e-cea9-7ce3-e063-6394a90a86f1 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
