ULTRACARE ORAL ANESTHETIC CREME DE MENTHE- benzocaine gel

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5)

Disponible desde:

Ultradent Products, Inc.

Designación común internacional (DCI):

Benzocaine

Composición:

Benzocaine 6.96 g in 30 mL

Vía de administración:

DENTAL

tipo de receta:

OTC DRUG

indicaciones terapéuticas:

Oral Anesthetic for the temporary relief of occasional minor irritation and pain, associated with: - minor dental procedures - sore mouth and throat - minor injury of the gums - canker sores - minor irritation of the mouth or gums caused by dentures or orthodontic appliances. - if tamper-evident seal is broken. Store at room temperature.

Estado de Autorización:

OTC monograph not final

Información para el usuario

ULTRACARE ORAL ANESTHETIC CREME DE MENTHE- BENZOCAINE GEL
Ultradent Products, Inc.
Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may be marketed if
they comply with applicable regulations and policies. FDA has not
evaluated whether this product
complies.
----------
ULTRACARE®
Oral Anesthetic Gel
Description:
Ultracare is a 20% benzocaine w/v (oral anesthetic gel) preparation in
a water-soluble glycol base. It is
available in 30ml bottles, 1.2ml single dose syringes, and in 30ml
IndiSpense® container syringes.
Special flavoring and sweetening agents are incorporated to render
flavors of superior taste (with no
aftertaste). Ultracare is designed for rapid onset (10-30 seconds).
Anesthesia usually lasts 8-10 minutes.
Benzocaine has been shown to be a safe, effective anesthetic with
little or no systemic absorption. The
incidence of allergic reaction is rare. Ultracare is NOT for
injection.
Uses:
For the temporary relief of occasional minor irritation and pain,
associated with:
•
minor dental procedures
•
sore mouth and throat
•
minor injury of the gums
•
canker sores
•
minor irritation of the mouth or gums caused by dentures or
orthodontic appliances.
Preliminary Steps:
1.
For preloaded 1.2ml syringes:
a.
Remove luer lock cap from syringe.
b.
Twist a Blue Micro ® tip or 5mm Micro Capillary
tip securely onto syringe.
c.
Hold syringe in palm of hand (as shown in Fig. 1) for
greater control, rather than in conventional manner
with thumb on plunger.
2.
For delivery from 30ml bottle:
a.
Remove lid.
b.
Dip cotton applicator in anesthetic.
3.
For IndiSpense delivery to cotton applicator:
a.
Remove cap from syringe.
b.
Express desired amount of anesthetic to cotton
applicator (Fig. 2).0
4.
For IndiSpense delivery to empty 1.2ml syringe:
a.
Attach a 1.2ml syringe to the end of IndiSpense by
turning the luer lock of syringe snugly onto male
thread of Indispense syringe.
b.
With palm, press plunger of IndiSpense syringe
gently while slowly pulling plunger of syringe out.
c.
Attach t

Ficha técnica

ULTRACARE ORAL ANESTHETIC CREME DE MENTHE- BENZOCAINE GEL
ULTRADENT PRODUCTS, INC.
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may be marketed if they_
_comply with applicable regulations and policies. FDA has not
evaluated whether this product complies._
----------
ULTRACARE
ORAL ANESTHETIC GEL
_DRUG FACTS_
ACTIVE INGREDIENT
Benzocaine 20% w/v
PURPOS E
Oral Anesthetic
US ES
for the temporary relief of occasional minor irritation and pain,
associated with:
minor dental procedures
sore mouth and throat
minor injury of the gums
canker sores
minor irritation of the mouth or gums caused by dentures or
orthodontic appliances.
DO NOT USE
if tamper-evident seal is broken. Store at room temperature.
WARNING
FOR EXTERNAL USE ONLY.
ALLERGY ALERT
Do not use if you have a history of allergy to local anesthetics such
as procaine, butacaine, benzocaine
or other "caine" anesthetics.
STOP USE AND ASK A DOCTOR
if sore throat is severe, persists for more than 2 days, is
accompanied or followed by fever,
headache, rash, swelling, nausea or vomiting
if sore mouth symptoms do not improve in 7 days, or if irritation,
pain, or redness persists or
worsens.
WHEN USING THIS PRODUCT
avoid contact with eyes.
KEEP OUT OF REACH OF CHILDREN. If more than used for pain is
accidentally swallowed, get medical help
or contact a Poison Control Center immediately.
®
DO NOT EXCEED RECOMMENDED DOSAGE.
DIRECTIONS
Adults and children 2 years of age
and older
Apply (a thin film) to affected area. Allow to remain in
place at least 1 minute and then spit out. Use up to 4
times daily as directed by a dentist or doctor.
Children under 12 years of age
Should be supervised in the use of this product.
Children under 2 years of age
Consult a dentist or a doctor.
OTHER
PHENYLKETONURICS: CONTAINS PHENYLALANINE 3MG PER GRAM.
INACTIVE INGREDIENTS
artificial flavor, aspartame, ethyl alcohol, FD&C blue #1, FD&C yellow
#5, glycerin, polyethylene
glycol, sodium saccharin.
QUESTIONS OR COMMENTS?
1-800-552-5512 or www.ultradent.com
Ultr