Dosage and administration
Indications: For rapid and long lasting topical anesthesia Directions: Apply 0.2mL of gel to the desired area using a cotton swab Active ingredients: Benzocaine 18.0% w/w, Tetracaine Hydrochloride 2.0% w/w
10039-CH Cherry Topical DentiCare Pro-Freeze Topical Anesthetic Gel
- Manufacturer
- AMD Medicom Inc.
- Effective date
- 2020-12-09
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 4
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 23:02:40
Label at a glance#
ProductDenti-Care Denti-Freeze Topical Anesthetic Cherry
Active ingredientBENZOCAINE, TETRACAINE HYDROCHLORIDE
Label structure7 sections
Storage and handling
Store at a temperature between 15ºC and 25ºC (59ºF - 77ºF)
Contacts and useful links#
Label contents#
Full prescribing information#
General Information
AMD Medicom Inc.
DentiCare Pro-Freeze
Topical Anesthetic Gel
Cherry
1 oz./ 28.4 g
NDC 64778-0394-1
DIN 02318148
Rx Only in US
Item code 10039-CH
Indications and Directions
Indications: For rapid and long lasting topical anesthesia
Directions: Apply 0.2mL of gel to the desired area using a cotton swab
Active ingredients: Benzocaine 18.0% w/w, Tetracaine Hydrochloride 2.0% w/w
Warnings
Warning:
KEEP OUT OF REACH OF CHILDREN
Do not use if allergic to benzocaine or any other ingredient in the product. Use with caution in children. Do not use in large quantities or over large areas of the body.
Methemoglobinemia Warning:
Products containing Benzocaine may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in the blood. This can occur even if this product was used before. Stop use and seek immediate attention if you or your child develops: pale, gray, or blue colored skin (cyanosis), headache, rapid heart rate, shortness of breath, dizziness or light-headedness and fatigue or lack of energy.
Drug Facts Table:
Warnings and Precautions/ Drug Interactions/ Patient Counceling Information
Storage
Store at a temperature between 15ºC and 25ºC (59ºF - 77ºF)
Contact 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
Principal Display Panel
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| benzocaine | ACTIVE INGREDIENT | U3RSY48JW5 | 1 | |
| tetracaine hydrochloride | ACTIVE INGREDIENT | 5NF5D4OPCI | 1 | |
| benzocaine | ACTIVE MOIETY | U3RSY48JW5 | 1 | |
| tetracaine | ACTIVE MOIETY | 0619F35CGV | 1 |
Products#
Every source-derived product name is available through these pages.
- Denti-Care Denti-Freeze Topical Anesthetic Cherry
- benzocaine, tetracaine hydrochloride
- BENZOCAINE
- TETRACAINE HYDROCHLORIDE
- TETRACAINE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 64778-0394 | 64778-0394-1, 64778-0394-2, 64778-0394-3 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BENZOCAINE | U3RSY48JW5 | ACTIB |
| TETRACAINE HYDROCHLORIDE | 5NF5D4OPCI | ACTIB |
Source Document#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| b60e5b37-e699-d454-e053-2995a90aee59 | 324146a5-e473-4a54-8543-38ee567e815e | 2020-12-09 | Warnings | b60e5b37-e699-d454-e053-2995a90aee59 324146a5-e473-4a54-8543-38ee567e815e |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.