ORAL GEL MAXIMUM STRENGTH- benzocaine gel

Oral Gel by

Drug Labeling and Warnings

Oral Gel by is a Otc medication manufactured, distributed, or labeled by Budpak Inc., Ausmetics Daily Chemicals (Guangzhou) Co. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient
Benzocaine 20%

PURPOSE

Purpose
Anesthetic

INDICATIONS & USAGE

Uses for the temporary relief of pain associated with:

• toothache  
  
• canker sores  
  
• cold sores  
  
• fever blisters  
  
• minor dental procedures

WARNINGS

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

When using this product

• avoid contact with the eyes  
  
• do not exceed recommended dosage
  

STOP USE

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 OUT OF REACH OF CHILDREN

Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

DOSAGE & ADMINISTRATION

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
  

SPL UNCLASSIFIED SECTION

Other information

• store at room temperature
• Lot No. and Exp. Date: see box or see crimp of tube
  

INACTIVE INGREDIENT

Inactive Ingredients Purified water, Glycerin, Propylene Glycol, Hydroxyethylcellulose, Carbomer, Sorbic Acid, Methylparaben, Propylparaben, FDC Yellow 5, FDC Red 40

PRINCIPAL DISPLAY PANEL

Package Label

INGREDIENTS AND APPEARANCE

ORAL GEL  MAXIMUM STRENGTH
benzocaine gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 27293-012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5)	BENZOCAINE	20 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBIC ACID (UNII: X045WJ989B)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 27293-012-01	1 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	Business Operations
Ausmetics Daily Chemicals (Guangzhou) Co. Ltd.		529836561	manufacture