DENTI-CARE DENTI-FREEZE TOPICAL ANESTHETIC MINT- 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.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

Medicom

Denti-Care

Denti-Freeze

Topical Anesthetic Ointment

Mint

1 oz / 29.6 ml

NDC: 64778-0496-1

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, yellow dye, blue dye, peppermint oil, spearmint oil

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., Pointe-Claire (Montreal), Canada H9P 2Z2

Questions: 1-800-361-2862

www.medicom.com

Item 10049-M

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DENTI-CARE DENTI-FREEZE  TOPICAL ANESTHETIC MINT
benzocaine ointment

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 64778-0496
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	green	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64778-0496-1	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 Inc. (256880576)