Oral Gel

Generic Name: benzocaine

Dosage Form: gel
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 NDC Product Code (Source) 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

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 27293-012-01 1 TUBE In 1 BOX contains a TUBE (27293-012-14) 1 27293-012-14 14 g In 1 TUBE This package is contained within the BOX (27293-012-01)

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: 01/2010Budpak Inc.

More Oral Gel resources

• Oral Gel Use in Pregnancy & Breastfeeding
• Oral Gel Support Group
• 6 Reviews for Oral - Add your own review/rating

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