FDA.reportPublic FDA data

10049-BG Bubble Gum Ointment Denti-Care Denti-Freeze Topical Anesthetic

Manufacturer
AMD Medicom Inc. | AMD Medicom
Effective date
2019-01-03
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-02 00:35:00

Label at a glance#

ProductDenti-Care Denti-Freeze Topical Anesthetic Bubblegum
Active ingredientBENZOCAINE
Label structure7 sections

Label contents#

Full prescribing information#

DESCRIPTION SECTION

AMD Medicom Inc.

DentiCare Pro-Freeze

Topical Anesthetic Ointment

Bubble Gum

1 oz / 28.4 g

NDC 64778-0493-1

Rx Only in US

Item code 10049-BG

DOSAGE & ADMINISTRATION SECTION

Rapid and long-lasting topical anesthesia

Directions: Apply 0.2 mL of ointment to the desired area using a cotton swab

Active ingredients: Benzocaine 20% w/w

INACTIVE INGREDIENT SECTION

Carbowax, sucralose, red dye, Bubble gum flavor

WARNINGS SECTION

KEEP OUT OF REACH OF CHILDREN

Store at room temperature

Do not expose to excessive heat over 40°C or 104°F

Warnings and Precautions/ Drug Interactions/ Patient Counceling Information

WARNINGS AND PRECAUTIONS SECTION

Warning 1Warning 1

SPL UNCLASSIFIED SECTION

Made in USA for AMD Medicom Inc.

2555 Chemin de l'Aviation

Pointe-Claire, Montreal, Quebec, Canada

H9P 2Z2

Questions: 1-800-361-2862

www.medicom.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Panel 1Panel 1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
benzocaineACTIVE INGREDIENTU3RSY48JW51
benzocaineACTIVE MOIETYU3RSY48JW51

Products#

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

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64778-049364778-0493-1

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
BENZOCAINEU3RSY48JW5ACTIB

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
7e9610c5-b88b-28fc-e053-2a91aa0ad65b58739ad0-8c8e-48cf-bec2-4336a67207ca2019-01-03WarningsExact identifier
spl id: 7e9610c5-b88b-28fc-e053-2a91aa0ad65b
spl set id: 58739ad0-8c8e-48cf-bec2-4336a67207ca

Reported adverse events (FAERS/openFDA)#

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