IODENT MAXIMUM STRENGTH ORAL ANALGESIC  - benzocaine gel 
United Exchange Corp

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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Drug Listing

Active ingredient                                                           Purpose

Benzocaine 20%...............................................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 Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics

Do not use

Stop use and ask a doctor if

Keep out of reach of children. In case of overdose or allergic reaction, get medical help or contact a Poison Control Center right away

Directions

Other information

Inactive ingredients flavor mint, glycerin, polyethylene glycol 400, polyethylene glycol 4000, saccharin sodium, sorbitol

Distributed by:

United Exchange Corp.

17211 Valley View Ave.

Cerritos, CA 90703 USA

Made in Korea

image of carton label

IODENT MAXIMUM STRENGTH ORAL ANALGESIC  
benzocaine gel
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:65923-010
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOCAINE (BENZOCAINE) BENZOCAINE20 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN 
POLYETHYLENE GLYCOL 400 
POLYETHYLENE GLYCOL 4000 
SACCHARIN SODIUM 
SORBITOL 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65923-010-111 in 1 CARTON
111.9 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35605/31/2013
Labeler - United Exchange Corp (840130579)

Revised: 5/2013
Document Id: 30c140ef-a81d-43a2-a4d4-62a713ec0352
Set id: 26d98371-6cac-4e4d-8aec-d88808339144
Version: 3
Effective Time: 20130531
 
United Exchange Corp