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

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Kupi sada

Preuzimanje Svojstava lijeka (SPC)
09-12-2020

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 0.2mL 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 RASPBERRY- 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-RB RASPBERRY TOPICAL
PRO-FREEZE TOPICAL ANESTHETIC GEL
GENERAL INFORMATION
AMD Medicom Inc.
DentiCare Pro-Freeze
Topical Anesthetic Gel
Raspberry
1 oz / 28.4 g
NDC 64778-0398-1
DIN 02318148
Rx Only in US
Item code 10039-RB
INDICATIONS AND DIRECTIONS
Indication: For rapid and long lasting topical anesthesia
Direction: Apply 0.2mL 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-ANES
THETIC-GEL/50/PRO-FREEZE-
TOPICAL-ANES THETIC-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 Inc.
2555 Chemin de l’Aviation
Pointe-Claire, Montreal, Quebec, Canada
H9P 2Z2
Questions: 1-800-361-2862
www.medicom.com
PRINCIPAL DISPLAY PANEL
DENTI-CARE DENTI-FREEZE TOPICAL ANESTHETIC RASPBERRY
benzocaine, tetracaine hydroc
                                
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