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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Active Ingredients: |
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Benzocaine | 14.0% |
Butamben | 2.0% |
Tetracaine Hydrochloride | 2.0% |
Benzalkonium chloride | 0.5% |
Cetyl Dimethyl Ethyl Ammonium Bromide | 0.005% |
In bland, water-soluble base. |
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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
patients.
Tissue need not be dried prior to application of OneTouch Advanced Gel. One-
Touch Advanced Gel should be applied directly to the site where pain control is
required. Anesthesia is produced within one minute with an approximate duration
of thirty minutes. Each 200 mg dose of OneTouch Advanced Gel contains 28 mg
of benzocaine, 4 mg of butamben and 4 mg of tetracaine HCI.
Precaution: On rare occasions, methemoglobinemia has been reported in
connection with the use of benzocaine-containing products. Care should be
used not to exceed the maximum recommended dosage (see Dosage and
Administration). If a patient becomes cyanotic, treat appropriately to counteract
(such as with methylene blue, if medically indicated).
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.
How-Supplied
OneTouch Advanced Gel, 32 g jar
Cool Mint | NDC 62565-901-01 |
Strawberry Ice | NDC 62565-902-01 |
Bubble Gum | NDC 62565-903-01 |
Cherry | NDC 62565-904-01 |
Caution: Rx Only.
Do not use in eyes. Keep out of reach of children. Directions: Read package insert. Press top of container to dispense desired amount. Dispense 200 mg of gel (a bead approximately 1/4 to 1/2 inches long) by gently depressing the pump. Dispensing a bead in excess of 400 mg is contraindicated. Spread thinly and evenly over the desired area using a cotton swab. 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 a bland water-soluble base. | NDC 62565-903-01 OneTouch Advanced Topical Anesthetic Gel OneTouch Advanced is indicated for anesthesia of accessible mucous membrane. Bubble Gum Net Wt. 32 g Store in a cool dry place. |
Manufactured for: HAGER WORLDWIDE Odessa, FL 33556 USA Item #6256590301 Made in U.S.A. Rev. 05/09 |
ONE TOUCH ADVANCED TOPICAL ANESTHETIC
BUBBLE GUM
benzocaine, butamben, tetracaine hydrochloride gel |
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Labeler - HAGER WORLDWIDE, INC. (009277971) |
Registrant - HAGER WORLDWIDE, INC. (009277971) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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HAGER WORLDWIDE, INC. | 009277971 | manufacture |