DENTI-CARE DENTI-FREEZE TOPICAL ANESTHETIC STRAWBERRY- benzocaine ointment
AMD Medicom Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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

General Information

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

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

Carbowax, sucralose, red dye, strawberry flavor

Warnings

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

Warning 1

Contact Information

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

Panel 1

DENTI-CARE DENTI-FREEZE TOPICAL ANESTHETIC STRAWBERRY
benzocaine ointment

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:64778-0499
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	0.2 g in 1 mL

Product Characteristics
Color	red	Score
Shape		Size
Flavor	STRAWBERRY	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:64778-0499-3	40 in 1 CASE	12/01/2017	08/31/2021
1	NDC:64778-0499-2	12 in 1 TRAY
1	NDC:64778-0499-1	29.6 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		07/28/2005	08/31/2021

Labeler - AMD Medicom Inc. (256880576)

Registrant - AMD Medicom Inc. (256880576)

Revised: 12/2020

Document Id: b60eb1ce-c65e-f81d-e053-2a95a90aa217

Set id: d2a5fb23-313a-4093-8967-13559bca5999

Version: 6

Effective Time: 20201209