ONE TOUCH ADVANCED TOPICAL ANESTHETIC BUBBLE GUM- benzocaine, butamben, tetracaine hydrochloride gel

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Nunua Sasa

Tabia za bidhaa Tabia za bidhaa (SPC)
23-11-2011

Viambatanisho vya kazi:

BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5), BUTAMBEN (UNII: EFW857872Q) (BUTAMBEN - UNII:EFW857872Q), TETRACAINE HYDROCHLORIDE (UNII: 5NF5D4OPCI) (TETRACAINE - UNII:0619F35CGV)

Inapatikana kutoka:

HAGER WORLDWIDE, INC.

INN (Jina la Kimataifa):

BENZOCAINE

Tungo:

BENZOCAINE 28 mg in .2 g

Njia ya uendeshaji:

TOPICAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

Indications OneTouch Advanced Gel is a topical anesthetic indicated for the production of anesthesia of all accessible mucous membrane except the eyes. OneTouch Advanced Gel is indicated for use to control pain in the mouth. Contraindications OneTouch Advanced Gel is not suitable and should never be used for injection. Do not use on the eyes. To avoid excessive systemic absorption, OneTouch Advanced Gel should not be applied to large areas of denuded or inflamed tissue. OneTouch Advanced Gel should not be administered to patients who are hypersensitive to any of its ingredients or to patients known to have cholinest-­ erase deficiencies. Tolerance may vary with status of the patient.   OneTouch Advanced Gel should not be used under dentures or cotton rolls, as retention of the active gel ingredients under a denture or cotton roll could pos-­ sibly cause an escharotic effect. Routine precaution for the use of any topical anesthetic should be observed when using OneTouch Advanced Gel.

Bidhaa muhtasari:

How-Supplied OneTouch Advanced Gel, 32 g jar

Idhini hali ya:

unapproved drug other

Tabia za bidhaa

                                ONE TOUCH ADVANCED TOPICAL ANESTHETIC BUBBLE GUM- BENZOCAINE,
BUTAMBEN,
TETRACAINE HYDROCHLORIDE GEL
HAGER WORLDWIDE, 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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ONETOUCH
ADVANCED
TOPICAL ANESTHETIC GEL RX Only
ACTIVE INGREDIENTS:
Benzocaine
14.0%
Butamben
2.0%
Tetracaine Hydrochloride
2.0%
INACTIVE INGREDIENTS:
Benzalkonium chloride
0.5%
Cetyl Dimethyl Ethyl Ammonium Bromide
0.005%
In bland, water-soluble base.
ACTION
The onset of OneTouch Advanced-produced anesthesia is rapid
(approximately
30 seconds) and the duration of anesthesia is typically 30-60 minutes,
when
used as directed. This effect is due to the rapid onset, but short
duration of
action of Benzocaine coupled with the slow onset, but extended
duration of
Tetracaine HCI and bridged by the intermediate action of Butamben.
It is believed that all of these agents act by reversibly blocking
nerve conduc-
tion. Speed and duration of action is determined by the ability of the
agent to
be absorbed by the mucous membrane and nerve sheath and then to
diffuse
out, and ultimately be metabolized (primarily by plasma
cholinesterases) to inert
metabolites which are excreted in the urine.
INDICATIONS
OneTouch Advanced Gel is a topical anesthetic indicated for the
production
of anesthesia of all accessible mucous membrane except the eyes.
OneTouch
Advanced Gel is indicated for use to control pain in the mouth.
DOSAGE AND ADMINISTRATION
Only a limited quantity is OneTouch Advanced Gel is required for
anesthesia.
Dispense 200 mg of gel (a bead approximately 1/4 to 1/2 inches long)
by gently
depressing the pump. Dispensing a bead of gel in excess of 400 mg is
contrain-
dicated. Spread thinly and evenly over the desired area using a cotton
swab.
An appropriate pediatric dosage has not been established for OneTouch
Ad-
vanced Gel.
Dosages should be reduced in the debilitated elderly, acutely ill, and
very young
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