Adventure Medical Kits Dental Medic

Manufacturer
Tender Corporation
Effective date
2017-03-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:49:24

Label at a glance#

ProductAdventure Medical Kits Dental Medic
Active ingredientBENZOCAINE
Label structure9 sections

Indications and uses

Temporarily relieves pain caused by: toothache, dental work, minor irritation or injury of the mouth and gums, canker sores, cheek bites, gum sores, and denture irritation.

Dosage and administration

Adults and children 2 years and older: dry affected area and apply medication undiluted. Use up to 4 times daily, but not more than every two hours, or as directed by a dentist or doctor. Consult a dentist or doctor for use on children under 2 years of age Children under 12 years of age should be supervised in the use of this product

Label contents#

Full prescribing information#

Active Ingredient - Oral Pain Relief

OTC - ACTIVE INGREDIENT SECTION

Benzocaine 20%

Purpose - Oral Pain Relief

OTC - PURPOSE SECTION

Oral Pain Reliever

Uses - Oral Pain Reliever

INDICATIONS & USAGE SECTION

Temporarily relieves pain caused by: toothache, dental work, minor irritation or injury of the mouth and gums, canker sores, cheek bites, gum sores, and denture irritation.

Warnings - Oral Pain Relief

WARNINGS SECTION

For oral use only. Avoid contact with eyes.

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 due to the possibility of anaphylactic shock.

When using this product

Do not use for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain or redness persists or worsens; or if swelling, rash, fever or other allergic reaction develops, see your doctor or dentist promptly. Do not exceed recommended dosage.

Keep out of reach of children

If more than used for pain relief is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions - Oral Pain Relief

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years and older: dry affected area and apply medication undiluted. Use up to 4 times daily, but not more than every two hours, or as directed by a dentist or doctor.

Consult a dentist or doctor for use on children under 2 years of age

Children under 12 years of age should be supervised in the use of this product

Other Information - Oral Pain Relief

OTC - WHEN USING SECTION

Do not use if packet is torn, cut, or opened

Store at room temperature, 15º to 30ºC (59º to 86ºF)

Avoid contact with eyes

Inactive Ingredients - Oral Pain Relief

INACTIVE INGREDIENT SECTION

PEG 400, PEG 3350, peppermint oil, sodium saccharin, sorbic acid

Keep out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of Reach of Children

Adventure Medical Kits Dental Medic

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dental MedicDental MedicDental MedicDental MedicOral Pain ReliefOral Pain Relief

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
248280benzocaine 20 % Dental CreamPSN1
248280benzocaine 200 MG/ML Oral CreamSCD1
248280benzocaine 20 % Dental CreamSY1

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44224-0102-02023-01-30C16284748780-1f386c649-c6d6-0266-e053-dadaa90a7c1aAdventure Medical Kits Dental Medic

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44224-0102-0Adventure Medical Kits Dental Medic1 in 1 BAGKIT11
61010-8100-2Adventure Medical Kits Dental Medic0.5 g in 1 PACKETLIQUID2 g in .5200 mg in 1g1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44224-0102ADVENTURE MEDICAL KITS DENTAL MEDIC (BENZOCAINE) KIT [TENDER CORPORATION]1Legacy NDC, 2 package rows20170327_4adc9c0d-9ef2-281b-e054-00144ff8d46c.zip
61010-8100ADVENTURE MEDICAL KITS DENTAL MEDIC (BENZOCAINE) KIT [TENDER CORPORATION]1Current NDC, Legacy NDC20170327_4adc9c0d-9ef2-281b-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44224-010244224-0102-0
61010-810061010-8100-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain ReliefBENZOCAINESafetec of America, Inc.de84e598-d047-4fae-b2ed-155a3788bc6f2024-02-16WarningsExact identifier
ndc (package): 61010-8100-2
ndc (product): 61010-8100
ndc11 (package): 61010810002
4adc9c0d-9ef3-281b-e054-00144ff8d46c4adc9c0d-9ef2-281b-e054-00144ff8d46c2017-03-16WarningsExact identifier
spl id: 4adc9c0d-9ef3-281b-e054-00144ff8d46c
spl set id: 4adc9c0d-9ef2-281b-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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