DENTI-CARE DENTI-FREEZE TOPICAL ANESTHETIC STRAWBERRY- benzocaine, tetracaine hydrochloride gel

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5), TETRACAINE HYDROCHLORIDE (UNII: 5NF5D4OPCI) (TETRACAINE - UNII:0619F35CGV)

Dostupno od:

AMD Medicom Inc.

INN (International ime):

benzocaine

Sastav:

benzocaine 0.18 g in 1 g

Administracija rute:

DENTAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Indication: For rapid and long lasting topical anesthesia Direction: Apply 0.2 mL of gel to the desired area using a cotton swab Active ingredient: Benzocaine 18.0% w/w, Tetracaine Hydrochloride 2.0% w/w

Status autorizacije:

unapproved drug other

Svojstava lijeka

DENTI-CARE DENTI-FREEZE TOPICAL ANESTHETIC STRAWBERRY- BENZOCAINE,
TETRACAINE HYDROCHLORIDE GEL
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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10039-ST STRAWBERRY TOPICAL
DENTI-CARE DENTI-FREEZE TOPICAL ANESTHETIC GEL
GENERAL INFORMATION
AMD Medicom Inc.
DentiCare Pro-Freeze
Topical Anesthetic Gel
Strawberry
1 oz / 28.4 g
NDC 64778-0399-1
DIN 02318148
Rx Only in US
Item code 10039-ST
INDICATIONS AND DIRECTIONS
Indication: For rapid and long lasting topical anesthesia
Direction: Apply 0.2 mL of gel to the desired area using a cotton swab
Active ingredient: 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:
https://www.medicom.com/en/products/61/pro-freeze-topical-anesthetic-gel/50/pro-freeze-topical-
anesthetic-gel-18-benzocaine-2-tetracaine
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
2555 Chemin de l'Aviation
Pointe-Claire, Montreal, Quebec
H9P 2Z2
Questions: 1-800-361-2862
www.medicom.com
PRINCIPAL DISPLAY PANEL
DENTI-CARE DENTI-FREEZE TOPICAL ANESTHETIC STRAWBERRY
benzocaine, tetracaine hydroch