DENTI-CARE DENTI-FREEZE TOPICAL ANESTHETIC BUBBLEGUM- benzocaine ointment

Denti-Care Denti-Freeze by

Drug Labeling and Warnings

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

Drug Details [pdf]

DESCRIPTION

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

DOSAGE & ADMINISTRATION

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

INACTIVE INGREDIENT

Carbowax, sucralose, red dye, Bubble gum 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

SPL UNCLASSIFIED SECTION

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 ointment

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 64778-0493
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	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	Marketing Start Date	Marketing End Date
1	NDC: 64778-0493-1	29.6 mL in 1 JAR; Type 0: Not a Combination Product	07/28/2005	12/31/2020

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)