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Denti-Care Denti-Freeze Topical Anesthetic

Generic name: benzocaine
Dosage form: ointment
Drug class: Topical anesthetics

Medically reviewed by Drugs.com. Last updated on Dec 22, 2020.

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.

AMD Medicom Inc.

DentiCare Pro-Freeze

Topical Anesthetic Ointment

Bubble Gum

1 oz / 28.4 g

NDC 64778-0493-1

Rx Only in US

Item code 10049-BG

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

Carbowax, sucralose, red dye, Bubble gum flavor

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

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

DENTI-CARE DENTI-FREEZE TOPICAL ANESTHETIC BUBBLEGUM
benzocaine ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:64778-0493
Route of Administration DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOCAINE (BENZOCAINE) BENZOCAINE 0.2 g in 1 mL
Product Characteristics
Color pink (fuschia) Score
Shape Size
Flavor BUBBLE GUM Imprint Code
Contains
Packaging
# Item Code Package Description
1 NDC:64778-0493-1 29.6 mL in 1 JAR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 07/28/2005 12/31/2020
Labeler - AMD Medicom Inc. (256880576)
Registrant - AMD Medicom (256880576)
AMD Medicom Inc.