IODENT SENSITIVE FRESH MINT- potassium nitrate and sodium floride paste 
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 ingredients                                                                        Purpose

Potassium nitrate 5%--------------------------------------------------- Antihypersensitivity

Sodium fluoride (0.15% w/v fluoride ion)------------------------------Anticavity

Uses

Warnings

Stop use and ask a dentist if

Keep out of reach of children.

If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults and children 12 years of age and older

children under 12 years of age:consult a dentist or doctor

Other Information

Inactive ingredients

Water, Silica, Sorbitol, Sodium Lauryl Alcohol, Polyethylene Glycol 300, Sodium Carboxymethylcellulose, Floavor, Sodium Sacchrin, Titanium Dioxide, Sodium Pyrophosphate, PEG/PPG 116/66 Copolymer, Color: Lemon Yellow & Bright Blue

Distributed by:

United Exchange Corp.

17211 Valley View Ave.

Cerritos, CA 90703 USA

image description

IODENT SENSITIVE FRESH MINT 
potassium nitrate and sodium floride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-101
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE5 mg  in 100 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION.15 mg  in 100 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
WATER (UNII: 059QF0KO0R)  
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
PEG/PPG-116/66 COPOLYMER (UNII: JP0CK963E0)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65923-101-131 in 1 CARTON12/21/2016
1113 g in 1 TUBE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35610/23/2014
Labeler - United Exchange Corp. (840130579)

Revised: 12/2016
Document Id: 9fb471d5-d147-4a7a-8f57-0690e8249f36
Set id: fc3514a3-7d58-495f-b14a-74b25416dc25
Version: 4
Effective Time: 20161221
 
United Exchange Corp.