Dentarin

Manufacturer
Vitamex USA, Corp.
Effective date
2024-08-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:17:58

Label at a glance#

ProductDentarin
Active ingredientBENZOCAINE
Label structure15 sections

Indications and uses

Uses: Temporarily relieves pain caused by toothache, canker, sores, cold sores, fever blisters, minor irritation or injury of the moth and gums.

Dosage and administration

Adults and children 2 years of age older | Apply to affected area up to 4 times daily or as directed by dentist or doctor Children under 12 years of age | Should be supervised in the use of this product Children under 2 years of age | Do not use Directions: Spray a small amount of product around the affected area up to 4 times daily.

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: Purpose

Benzocaine 20%............................... Oral Pain Reliever

Uses:

OTC - PURPOSE SECTION

Uses: Temporarily relieves pain caused by toothache, canker, sores, cold sores, fever blisters, minor irritation or injury of the moth and gums.

Warnings: Methemoglobinemia warning:

WARNINGS SECTION

Warnings: Methemoglobinemia warning: Use of this product may cause methemoglobinemia, a serious condiiton tha tmust 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 pal, gray, or blue colored skin cyanosis), headache, rapid heartbeat, shortness of breath, diziness or lightheadedness, fatigue or lack of enerygy. Keep away from eyes.

Allergy alert

OTHER SAFETY INFORMATION

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. If a skin reaction occurs, stop use and seek medical attention right away.

Flammability warning

OTHER SAFETY INFORMATION

Flammability warning: keep away from fire or flame

Do not use

OTC - DO NOT USE SECTION

Do not use: more than directed, for more than 7 days unless told to do so by a dentist or doctor, for teething, in children under 2 years of age.

Stop use and ask a doctor if

OTC - STOP USE SECTION

Stop use and ask a doctor if: sore mouth symptoms do not improve in 7 days, swelling, rash or fever develops, pain or redness persists or worsens.

If pregnant or breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a health professional before use

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of rech of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions:

INDICATIONS & USAGE SECTION

Adults and children 2 years of age older | Apply to affected area up to 4 times daily or as directed by dentist or doctor
Children under 12 years of age | Should be supervised in the use of this product
Children under 2 years of age | Do not use

Directions: Spray a small amount of product around the affected area up to 4 times daily.

Other information

OTHER SAFETY INFORMATION

Other information: Store at controlled room temperature: 15-30ºC (59-86ºF). Tamper Evident Feature: Do not use if cello-band over cap is torn, broken or missing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients: alcohol, clove oil, glycerin, polyethylene glycol, propylene glycol, sodium methylparaben, sodium saccharin

Change in section type:

RECENT MAJOR CHANGES SECTION

Change in section type from directions to indications and useage

Doseage and administration

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age older | Apply to affected area up to 4 times daily or as directed by dentist or doctor
Children under 12 years of age | Should be supervised in the use of this product
Children under 2 years of age | Do not use

Directions: Spray a small amount of product around the affected area up to 4 times daily.

Dentarin

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dentarin

Balsamo Dental En Spray

Helps relieve Toothache and Mouth Sores

Net Contents: 1 Fl. Oz (30mL)

Dentarin LabelDentarin Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
360348benzocaine 20 % Mucosal SprayPSN1
360348benzocaine 200 MG/ML Mucosal SpraySCD1
360348benzocaine 20 % Mucosal SpraySY1

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
69469-200-30Dentarin30 mL in 1 BOTTLE, SPRAYSOLUTION301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69469-200DENTARIN (BENZOCAINE 20%) SOLUTION [VITAMEX USA, CORP.]11 package rows20240829_20b39f18-0b8d-9f01-e063-6394a90a213e.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69469-20069469-200-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 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
20b39f18-0b8e-9f01-e063-6394a90a213e20b39f18-0b8d-9f01-e063-6394a90a213e2024-08-27WarningsExact identifier
spl id: 20b39f18-0b8e-9f01-e063-6394a90a213e
spl set id: 20b39f18-0b8d-9f01-e063-6394a90a213e

Reported adverse events (FAERS/openFDA)#

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