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Benz O Sthetic by Geritrex LLC

Medically reviewed on August 10, 2016

Dosage form: gel
Ingredients: BENZOCAINE 20g in 100g
Labeler: Geritrex LLC
NDC Code: 54162-926

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 Gel

Drugs Facts


Active Ingredients Purpose
Benzocaine 20% Anesthetic

Uses

For temporary relief of oral pain associated with: · toothache ·canker sores ·minor dental
procedures · minor injury of the mouth and gum caused by dentures or orthodontic appliances.

Directions

Apply with cotton applicator or finger tip to affected gum area
up to 4 times a day or as directed by your dentist.

Do not use for more thatn 7 days.

Warnings

Do not use this product if you have a history of allergy to
local anesthetic such as Procaine, Benzocaine or other
“Caines”. Not recommended for children under the age of 2.

Other Ingredients

Benzyl Alcohol, Cherry Flavor, FD&C Red #40, PEG 3350, PEG 400, Sodium Saccharin

Storage

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

Keep out of reach of children

KEEP OUT OF REACH OF CHILDREN



BENZ O STHETIC 
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-926
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE20 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
FD&C RED NO. 40 
POLYETHYLENE GLYCOL 400 
POLYETHYLENE GLYCOL 3350 
SACCHARIN SODIUM 
Packaging
#Item CodePackage Description
1NDC:54162-926-1515 g in 1 TUBE
2NDC:54162-926-2929 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35607/31/2015
Labeler - Geritrex LLC (112796248)
Establishment
NameAddressID/FEIOperations
Geritrex LLC112796248manufacture(54162-926)

 
Geritrex LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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