BENZ O STHETIC - benzocaine spray 
Geritrex Corp.

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.

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Benz-O-Sthetic Spray

Drugs Facts

Active Ingredients Purpose
Benzocaine 20% Oral Anesthetic

Uses

For control of pain; Topical anesthetic for oral or mucosal areas. To
suppress the gag reflex.

Directions

May be used with extension tube for finer direct application. For anesthetic
use in mouth or throat: pump spray 2-3 times or as needed. Repeat if needed
for larger areas. Anesthetic effect is reached in 15-30 seconds.

Children under 6yrs of age use as directed by dentist/doctor.

Warnings


Do not use this product if patient has a history of allergy to local anesthetics
such as procaine, butacaine, benzocaine, or other “caine” anesthetics. Do not
spray into or near eyes. Do not inhale.
Patient: When using extension tube, do not spray in the back of the throat
unless your dentist or doctor directed you to do so.
When using this product:
Π Avoid use near eyes Π Do not use more than recommended dosage
Π Do not go beyond 7 days usage, unless directed by your doctor/dentist
Patient: Discontinue use and consult a physician if: sore mouth symptoms do
not improve in 5 days; irritation, pain, or redness persists or worsens;
swelling, rash, or fever develops.

Other Ingredients

Benzyl alcohol, flavor, polyethylene glycol, SDA38B,
Sodium Saccharine

Storage

store at controlled room temperature 20-25°C (68-77°F)

Keep out of reach of children

KEEP OUT OF REACH OF CHILDREN

Label of BottleEnter section text here

BENZ O STHETIC 
benzocaine spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-925
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
N,N-BIS(2-HYDROXYETHYL)-P-PHENYLENEDIAMINE SULFATE (UNII: 3X5A8DP6HC)  
SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY)  
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRY (CHERRY) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54162-925-0259 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/13/2012
Labeler - Geritrex Corp. (112796248)

Revised: 2/2012
Document Id: 2020e17e-7b52-4104-827c-045bde3c7e04
Set id: 92f1bddd-71af-427a-bce6-727adca90999
Version: 2
Effective Time: 20120213
 
Geritrex Corp.