DENTI-CARE DENTI-FREEZE TOPICAL ANESTHETIC STRAWBERRY- benzocaine, tetracaine hydrochloride gel
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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10039-ST Strawberry Topical
Denti-Care Denti-Freeze Topical Anesthetic Gel

General Information

AMD Medicom Inc.

DentiCare Pro-Freeze

Topical Anesthetic Gel

Strawberry

1 oz / 28.4 g

NDC 64778-0399-1

DIN 02318148

Rx Only in US

Item code 10039-ST

Indications and Directions

Indication: For rapid and long lasting topical anesthesia

Direction: Apply 0.2 mL of gel to the desired area using a cotton swab

Active ingredient: Benzocaine 18.0% w/w, Tetracaine Hydrochloride 2.0% w/w

Warnings

Warning:

KEEP OUT OF REACH OF CHILDREN

Do not use if allergic to benzocaine or any other ingredient in the product. Use with caution in children. Do not use in large quantities or over large areas of the body.

Methemoglobinemia Warning:

Products containing Benzocaine may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in the blood. This can occur even if this product was used before. Stop use and seek immediate attention if you or your child develops: pale, gray, or blue colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or light-headedness and fatigue or lack of energy.

Drug Facts Table:

https://www.medicom.com/en/products/61/pro-freeze-topical-anesthetic-gel/50/pro-freeze-topical-anesthetic-gel-18-benzocaine-2-tetracaine

Warnings and Precautions/ Drug Interactions/ Patient Counceling Information

Warning 1

Storage

Store at a temperature between 15ºC and 25ºC (59ºF - 77ºF)

Contact Information

Made in USA for AMD Medicom

2555 Chemin de l'Aviation

Pointe-Claire, Montreal, Quebec

H9P 2Z2

Questions: 1-800-361-2862

www.medicom.com

Principal Display Panel

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DENTI-CARE DENTI-FREEZE TOPICAL ANESTHETIC STRAWBERRY
benzocaine, tetracaine hydrochloride gel

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:64778-0399
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	0.18 g in 1 g
TETRACAINE HYDROCHLORIDE (UNII: 5NF5D4OPCI) (TETRACAINE - UNII:0619F35CGV)	TETRACAINE HYDROCHLORIDE	0.02 g in 1 g

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:64778-0399-3	40 in 1 CASE	12/01/2017	09/30/2021
1	NDC:64778-0399-2	12 in 1 TRAY
1	NDC:64778-0399-1	28.4 g 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		02/01/2000	09/30/2021

Labeler - AMD Medicom Inc. (256880576)

Registrant - AMD Medicom Inc. (256880576)

Revised: 12/2020

Document Id: b60e7dd1-c5ad-b797-e053-2995a90a16b7

Set id: 6ac9623e-35d5-45a7-8a13-0f00c13b4527

Version: 4

Effective Time: 20201209