DENTI-CARE DENTI-FREEZE TOPICAL ANESTHETIC MINT- 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.

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10049-M Mint Ointment
Denti-Care Denti-Freeze Topical Anesthetic

Medicom

Denti-Care

Denti-Freeze

Topical Anesthetic Ointment

Mint

1 oz / 29.6 ml

NDC 64778-0496-1

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

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

Made in USA for: AMD Medicom Inc., Pointe-Claire (Montreal), Canada H9P 2Z2

Questions: 1-800-361-2862

www.medicom.com

Item 10049-M

Panel 01

DENTI-CARE DENTI-FREEZE TOPICAL ANESTHETIC MINT
benzocaine ointment

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	0.2 g in 1 mL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:64778-0496-1	29.6 mL in 1 JAR; Type 0: Not a Combination Product	07/28/2005	12/31/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		07/28/2005	12/31/2020

Labeler - AMD Medicom Inc. (256880576)

Registrant - AMD Medicom Inc. (256880576)

Revised: 1/2019

Document Id: 7e942fcb-4b3d-915e-e053-2a91aa0a8b99

Set id: 563dbad6-3b16-4cbd-b3f2-076cefa73ebb

Version: 3

Effective Time: 20190103

AMD Medicom Inc.