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

Denti-Care Denti-Freeze by

Drug Labeling and Warnings

Denti-Care Denti-Freeze by is a Prescription medication manufactured, distributed, or labeled by AR Medicom Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

General Information

AMD Medicom Inc.

DentiCare Pro-Freeze

Topical Anesthetic Gel

Bubble Gum

1 oz / 28.4 g

NDC: 64778-0393-1

DIN 02318148

Rx Only in US

Item code 10039-BG

Indications and Directions

Indication: For rapid and long lasting topical anesthesia

Direction: Apply 0.2mL 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

Storage

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

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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 64778-0393
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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	pink (fuschia)	Score
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64778-0393-3	40 in 1 CASE	12/01/2017	11/30/2020
1	NDC: 64778-0393-2	12 in 1 TRAY
1	NDC: 64778-0393-1	28.4 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		02/01/2000	11/30/2020

Labeler - AMD Medicom Inc. (256880576)

Registrant - AMD Medicom Inc. (256880576)