DENTI-CARE DENTI-FREEZE TOPICAL ANESTHETIC CHERRY- 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.

----------

10049-CH Cherry Ointment
DentiCare Pro-Freeze Topical Anesthetic

General Information

AMD Medicom Inc.

DentiCare Pro-Freeze

Topical Anesthetic Ointment

Cherry

1 oz / 28.4 g

NDC 64778-0494-1

Rx Only in US

Item code 10049-CH



Indication 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, cherry 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 CHERRY
benzocaine ointment
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:64778-0494
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE0.2 g  in 1 mL
Product Characteristics
ColorredScore    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64778-0494-340 in 1 CASE12/01/201708/31/2021
1NDC:64778-0494-212 in 1 TRAY
1NDC:64778-0494-129.6 mL in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other07/28/200508/31/2021
Labeler - AMD Medicom Inc. (256880576)
Registrant - AMD Medicom Inc. (256880576)

Revised: 12/2020
 
AMD Medicom Inc.