FDA.reportPublic FDA data

10049-ST Strawberry Ointment Denti-Care Denti-Freeze Topical Anesthetic

Manufacturer
AMD Medicom Inc.
Effective date
2020-12-09
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 23:02:59

Label at a glance#

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

Dosage and administration

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

Label contents#

Full prescribing information#

General Information

DESCRIPTION SECTION

AMD Medicom Inc.

DentiCare Pro-Freeze

Topical Anesthetic Ointment

Strawberry

1 oz / 28.4 g

NDC 64778-0499-1

Rx Only in US

Item code 10049-ST

Indications and Directions

INDICATIONS & USAGE 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

Non-Medicinal Ingredients

INACTIVE INGREDIENT SECTION

Carbowax, sucralose, red dye, strawberry flavor

Warnings

WARNINGS AND PRECAUTIONS 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

Contact Information

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



Principal Display Panel

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
64778-049964778-0499-1, 64778-0499-2, 64778-0499-3

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
b60eb1ce-c65e-f81d-e053-2a95a90aa217d2a5fb23-313a-4093-8967-13559bca59992020-12-09WarningsExact identifier
spl id: b60eb1ce-c65e-f81d-e053-2a95a90aa217
spl set id: d2a5fb23-313a-4093-8967-13559bca5999

Reported adverse events (FAERS/openFDA)#

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