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Benz O Sthetic by Geritrex LLC

Medically reviewed on Sep 28, 2017

Dosage form: spray
Ingredients: BENZOCAINE 11.8g in 59mL
Labeler: Geritrex LLC
NDC Code: 54162-929

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.

Benz-O-Sthetic Spray

Drugs Facts

Active Ingredients                       Purpose
Benzocaine 20%........................Oral Anesthetic

Uses

Topical anesthetic for the temporary relief of occasional minor irritation and pain, associated with:
canker sores

  • sore mouth and throat
  • minor dental procedures
  • minor irritation of the mouth and gums caused by dentures or orthodontic appliances
  • minor injury of the mouth and gums

Directions

May be used with extension tube for finer direct application. For adults and children 2 years and older anesthetic use in mouth or throat:
Pump spray 2-3 times up to 4 times. Repeat if needed for larger areas. Anesthetic effect is reached in 15-30 seconds. Children under 12 years of age should be supervised and 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:

  • Avoid use near eyes
  • Do not use more than recommended dosage
  • 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

Alcohol, benzyl alcohol, flavor, peppermint oil, polyethylene glycol, sodium saccharin

Other Information:

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

KEEP OUT OF REACH OF CHILDREN

Caution:​ ​If accidental or excessive ingestion occurs (exceeds recommended dosage) contact a physician for immediate advice or call a Poison Control Center. 

BENZ O STHETIC 
benzocaine spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-929
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE11.8 g  in 59 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
POLYETHYLENE GLYCOL 400 
PEPPERMINT OIL 
SACCHARIN SODIUM 
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRY (CHERRY) Imprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:54162-929-0259 mL in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/30/2017
Labeler - Geritrex LLC (112796248)
Establishment
NameAddressID/FEIOperations
Geritrex LLC112796248manufacture(54162-929)

 
Geritrex LLC

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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