Video: Latest Treatment for Hep C.

Oral Gel

Pronunciation

Generic Name: benzocaine
Dosage Form: gel

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.

Drug Facts

Active Ingredient
Benzocaine 20%
Purpose
Anesthetic
Uses for the temporary relief of pain associated with:
  • toothache  
  • canker sores  
  • cold sores  
  • fever blisters  
  • minor dental procedures
Warnings
  • do not use for more than 7 days unless directed by a dentist or a doctor
  • if you have a history of allergy to local anesthetics such as procaine, butacaine or other "caine" anesthetics
When using this product
  • avoid contact with the eyes  
  • do not exceed recommended dosage
Stop using and ask a doctor
  • sore mouth symptoms do not improve in 7 days
  • swelling, rash or fever develops
  • irritation, pain or redness persists or worsens
Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away
Directions adults and children 2 years of age and older:
  • cut open tip of tube
  • apply to the affected area up to 4 times daily or as directed by a dentist or doctor
  • children under 12 years of age should be supervised in the use of the product
  • children under 2 years of age, there is no recommended dosage except under the advice and supervision of a dentist or a doctor
Other information
  • store at room temperature
  • Lot No. and Exp. Date: see box or see crimp of tube
Inactive Ingredients Purified water, Glycerin, Propylene Glycol, Hydroxyethylcellulose, Carbomer, Sorbic Acid, Methylparaben, Propylparaben, FDC Yellow 5, FDC Red 40
Package Label

Oral Gel  MAXIMUM STRENGTH
benzocaine gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:27293-012
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOCAINE (BENZOCAINE) BENZOCAINE 20 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER  
GLYCERIN  
PROPYLENE GLYCOL  
SORBIC ACID  
METHYLPARABEN  
PROPYLPARABEN  
FD&C YELLOW NO. 5  
FD&C RED NO. 40  
Packaging
# Item Code Package Description
1 NDC:27293-012-01 1 TUBE (TUBE) in 1 BOX
1 NDC:27293-012-14 14 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part356 02/01/2010
Labeler - Budpak Inc. (183224849)
Establishment
Name Address ID/FEI Operations
Ausmetics Daily Chemicals (Guangzhou) Co. Ltd. 529836561 manufacture
Revised: 01/2010
 
Budpak Inc.



Hide
(web3)