Oral pain relief

Manufacturer
ALAINA HEALTHCARE PRIVATE LIMITED
Effective date
2025-12-09
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:21:28

Label at a glance#

ProductOral pain relief
Active ingredientBENZOCAINE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts

Active ingredients                                                                        Purpose

Benzocaine 20%....................................................................Oral pain reliever

INDICATIONS & USAGE SECTION

Uses

  • temporarily relieves pain associated with the following mouth and gum irritations:
  • toothache
  • canker sores
  • minor dental procedures
  • dentures
  • sore gums
  • braces

WARNINGS SECTION

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.

Do not use:

  • for teething
  • in children under 2 years of age

OTC - ASK DOCTOR SECTION

When using this product:

  • avoid contact with the eyes
  • do not exceed recommended dosage
  • do not use for more than 7 days unless directed by a doctor/dentist

Stop use and ask doctor if

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions:

adults and children 2 years of age and over

apply a pea-size amount to the affected area up to 4 times daily or as directed by a doctor/dentist

children under 12 years of age

adult supervision should be given in the use of this product

children under 2 years of age

do not use

  • For denture irritation:
  • apply thin layer to the affected area
  • do not reinsert dental work until irritation/pain is relieved
  • rinse mouth well before reinserting

Other information

  • store at 20-25°C (68-77°F)
  • do not refrigerate

INACTIVE INGREDIENT SECTION

Inactive Ingredients

benzyl alcohol, carbomer, D&C red no. 33, FD&C blue no. 1, FD&C yellow no. 6, glycerin, natural flavor, polyethylene glycol, polysorbate 80, propylene glycol, sodium saccharin, sorbic acid

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAXIMUM STRENGTH

ORAL PAIN RELIEF GEL

FAST ACTING

Benzocaine 20% pain relieving gel

NET WT 0.5 OZ (14g)

labellabel

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
238910benzocaine 20 % Oral GelPSN3
238910benzocaine 0.2 MG/MG Oral GelSCD3
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSY3

DailyMed Pharmacologic Classes#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73492-717-50Oral pain relief1 in 1 CARTONGEL13
73492-717-50Oral pain relief14 g in 1 TUBEGEL143

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73492-71773492-717-50

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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
Oral pain reliefBENZOCAINEALAINA HEALTHCARE PRIVATE LIMITEDd98c1b2f-fe75-4d52-b082-1abb7628c59e2025-12-09WarningsExact identifier
ndc (package): 73492-717-50
ndc (product): 73492-717
ndc11 (package): 73492071750
spl id: 4584247f-6422-216f-e063-6294a90a0d80
spl set id: d98c1b2f-fe75-4d52-b082-1abb7628c59e

Reported adverse events (FAERS/openFDA)#

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