Exactacain Topical Anesthetic Spray

Generic Name: benzocaine, butamben, tetracaine hydrochloride
Dosage Form: aerosol, spray

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.


Exactacain Topical Anesthetic Spray

Use As Directed

Not for ophthalmic use.


Active Ingredients:

Benzocaine .......................14.0% w/w

Butamben ...........................2.0% w/w

Tetracaine Hydrochloride ....2.0% w/w

(Percentages refer to concentrate and exclude propellant) 


Contains:

Benzalkonium Chloride, Cetyldimethylethylammonium bromide, Dipropylene Glycol, Flavoring (Cherry), Saccharin. Also Contains: Propellant HFA-134a 1,1,1,2-tetrafluoroethane).

Action:

The onset of Exactacain 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.

Slideshow: View Frightful (But Dead Serious) Drug Side Effects

It is believed that all of these agents act by reversibly blocking nerve conduction. 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:

Exactacain is a topical anesthetic indicated for the production of anesthesia of all accessible mucous membrane except the eyes. Exactacain is indicated for use to control pain or gagging. Exactacain is indicated for use to control pain and for use for surgical and endoscopic or other procedures in the ear, nose, mouth, pharynx, larynx, trachea, bronchi, and esophagus. It may also be used for vaginal or rectal procedures when feasible.

Dosage and Administration:

Apply 3 metered sprays of Exactacain for normal anesthesia. Dosing in excess of 6 metered sprays is contraindicated. Tissue need not be dried prior to application of Exactacain. Exactacain should be applied directly to the site where pain control is required.

Adverse Reactions:

Hypersensitivity Reactions: Unpredictable adverse reactions (ie, hypersensitivity, including anaphylaxis) are extremely rare.

Localized allergic reactions may occur after prolonged or repeated use of any aminobenzoate anesthetic. The most common adverse reaction caused by local anesthetics is contact dermatitis characterized by erythema and pruritus that may progress to vesiculation and oozing. This occurs most commonly in patients following prolonged self-medication, which is contraindicated. If rash, urticaria, edema, or other manifestations of allergy develop during use, the drug should be discontinued. To minimize the possibility of a serious allergic reaction, Exactacain preparation should not be applied for prolonged periods except under continual supervision. Dehydration of the epithelium or an escharotic effect may also result from prolonged contact.

Precaution:

On rare occasions, methemoglobinemia has been reported in connection with the use of products containing Benzocaine and related compounds. Care should be used not to exceed 6 metered sprays. If a patient becomes cyanotic, treat appropriately to counteract (such as with methylene blue, if medically indicated).

Use in Pregnancy:

Safe use of Exactacain has not been established with respect to possible adverse effects upon fetal development. Therefore, Exactacain should not be used during early pregnancy, unless in the judgment of a physician, the potential benefits outweigh the unknown hazards. Routine precaution for the use of any topical anesthetic should be observed when Exactacain is used.

Use in pediatric and geriatric populations:

Appropriate pediatric and geriatric dosage has not been established for this product. Dosage should be reduced in the debilitated elderly, acutely ill, very young patients or others with conditions resulting in a greater risk from methemoglobinemia.

Contraindications:

Exactacain is not suitable and should never be used for injection. Do not use on the eyes. To avoid excessive systemic absorption, Exactacain should not be applied to large areas of denuded or inflamed tissue. Exactacain should not be administered to patients who are hypersensitive to any of its ingredients or to patients known to have cholinesterase deficiencies. Tolerance may vary with the status of the patient. Dosage should be reduced in the debilitated elderly, acutely ill, very young patients or others with conditions resulting in a greater risk from methemoglobinemia.

Individual dosage of tetracaine hydrochloride in excess of 6 metered sprays is contraindicated. Exactacain should not be used under dentures or cotton rolls, as retention of the active ingredients under a denture or cotton roll could possibly cause an escharotic effect. Routine precaution for the use of any topical anesthetic should be observed when using Exactacain.


Disposable Applicators for Exactacain Spray:

  • The 5” Exactacain disposable, single-use applicators are designed for accessibility and
    application of Exactacain, at the required site of pain control
  • A disposable applicator is inserted firmly into the spray nozzle on the can of Exactacain
  • The disposable applicator should be discarded after each patient use and a new disposable applicator inserted prior to the next use of the product

How Supplied:

Exactacain is available in a 60 g can (including propellant) NDC 16781-113-60, packaged with 100 disposable applicators. Additional disposable applicators are available (order number 16781-113-00).

Contents Under Pressure: Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 120°F may cause bursting. Never throw container into fire or incinerator. Keep out of reach of children. DO NOT spray in eyes.

Store at controlled room temperature, 20°C-25°C (68°F-77°F). The canister should be at room temperature before use.

Marketed by: 

Cumberland, RI 02864

(888) 713-8154

www.onsettx.com


Reorder No:

Exactacain Spray 16781-113-60

Additional Disposable Applicators:

16781-113-00


P/N 2601 Rev. 0

Revision Date: 9/08


Exactacain is a trademark of Onset Therapeutics

Patent pending.


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL – Box with 60 g Can and Disposable Applicators


NDC 16781-113-60

Rx ONLY


ExactacainTM
(benzocaine 14%, butamben 2%, tetracaine hydrochloride 2%) spray

Topical Anesthetic


Contents:

One 60 gram can of Exactacain Spray

100 disposable applicators


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL – Can, 60 Grams

NDC 16781-113-60

Rx ONLY


Exactacain®
(benzocaine 14%, butamben 2%, tetracaine hydrochloride 2%) spray


Topical Anesthetic


60 GRAMS


EXACTACAIN  TOPICAL ANESTHETIC
benzocaine,butamben,tetracaine hydrochloride aerosol, spray
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:16781-113
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOCAINE (BENZOCAINE) BENZOCAINE 14 g  in 100 g
BUTAMBEN (BUTAMBEN) BUTAMBEN 2 g  in 100 g
TETRACAINE HYDROCHLORIDE (TETRACAINE) TETRACAINE HYDROCHLORIDE 2 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
DIPROPYLENE GLYCOL  
BENZALKONIUM CHLORIDE  
SACCHARIN  
Packaging
# Item Code Package Description
1 NDC:16781-113-60 1 CAN (1 CAN) in 1 BOX
1 60 g in 1.0 CAN
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 06/23/2005 10/31/2012
Labeler - Onset Dermatologics LLC (793223707)
Registrant - Onset Dermatologics LLC (964275155)
Establishment
Name Address ID/FEI Operations
Onset Dermatologics LLC 793223707 Manufacture
Revised: 11/2011
 
Onset Dermatologics LLC



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