ORAL ANALGESIC MAXIMUM STRENGTH- benzocaine gel 
LIFElabs, a Division of Atico International USA, INC.

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.

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LIFElabs, a Division of Atico International USA, INC.

Oral Analgesic (Maximum Strength)

Active Ingredient

Benzocaine 20%

Purpose

Oral pain reliever


Uses

temporarily relieves pain due to toothache, canker sores, cold sores, fever blisters,  minor irritation of the mouth and gums caused by dentures or orthodontic appliances

Warnings

for temporary use only until a dentist can be consulted



Allergy alert:

do not use this product if you have a history of allergy to local anesthetics such a procaine, butacaine, benzocaine or other "caine" anesthetics.

When using this product

Stop use and ask a doctor if

Keep out of reach of children.

In cases of overdose, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive Ingredients

d-sorbitol solution, glycerin, peppermint flavor, polyethylene glycol 400, polyethylene glycol 4000, saccharin sodium

Questions?

Call 1-800-645-3867, Mon-Fri 8:30 AM - 5:30 PM.

Image of Oral Analgesic Gel Carton Label

Image of Oral Analgesic Gel Tube Label




ORAL ANALGESIC  MAXIMUM STRENGTH
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51852-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Sorbitol (UNII: 506T60A25R)  
Glycerin (UNII: PDC6A3C0OX)  
Peppermint (UNII: V95R5KMY2B)  
Polyethylene Glycol 400 (UNII: B697894SGQ)  
Polyethylene Glycol 4000 (UNII: 4R4HFI6D95)  
Saccharin Sodium (UNII: SB8ZUX40TY)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51852-101-011 in 1 CARTON
111.9 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35611/01/2010
Labeler - LIFElabs, a Division of Atico International USA, INC. (073876450)

Revised: 8/2010
Document Id: 551c24bc-8859-4a83-b32b-1237329a7ffb
Set id: 2670754a-0fc5-4d08-a851-c8b725572826
Version: 5
Effective Time: 20100817
 
LIFElabs, a Division of Atico International USA, INC.