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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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 description

IODENT MAXIMUM STRENGTH ORAL ANALGESIC  
benzocaine gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:65923-010
Route of Administration TOPICAL DEA Schedule     
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
GLYCERIN (UNII: PDC6A3C0OX)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:65923-010-11 1 in 1 CARTON
1 11.9 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part356 05/31/2013
Labeler - United Exchange Corp (840130579)

Revised: 12/2014
Document Id: 2ae3fd7b-8630-49fb-ba13-b7c0f0c7a1e8
Set id: 26d98371-6cac-4e4d-8aec-d88808339144
Version: 5
Effective Time: 20141205
 
United Exchange Corp