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Denti-Care Denti-Freeze Topical Anesthetic: Package Insert / Prescribing Info

Package insert / product label
Generic name: benzocaine
Dosage form: ointment
Drug class: Topical anesthetics

Medically reviewed by Drugs.com. Last updated on Jan 20, 2025.

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

Warning 1

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

Panel 1

DENTI-CARE DENTI-FREEZE TOPICAL ANESTHETIC BUBBLEGUM
benzocaine ointment
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:64778-0493
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
Colorpink (fuschia) Score
ShapeSize
FlavorBUBBLE GUMImprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64778-0493-129.6 mL in 1 JAR; Type 0: Not a Combination Product07/28/200512/31/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other07/28/200512/31/2020
Labeler - AMD Medicom Inc. (256880576)
Registrant - AMD Medicom (256880576)

Medical Disclaimer