IODENT SENSITIVE EXTRA WHITENING- sodium fluoride potassium nitrate 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.

----------

Active Ingredients                                         Purpose

Potassium nitrate 5%....................................Antihypersensitivity

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

Uses

  • builds increasing protection against painful sensitivity of the teeth due to cold, heat, acids, sweets or contact
  • aids in the prevention of dental cavities

Warnings

Stop use and ask a dentist if

  • the problem persists or worsens. Sensitive teeth mauy indicate a serious problem that may prompt care by a dentist
  • pain/sensitivity stil persists after 4 weeks of use

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
  • apply at least a 1-inch strip of product onto a soft bristle toothbrush
  • brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing.
  • children under 12 years of age: consult a dentist or doctor

Other information

  • sore at room temperature 20-25°C (68-77°F)

Inactive ingredients

sorbitol, hydrated silica, water, PEG-1500, sodium lauryl sulfate, flavor, glycerin, cellulose gum, tetrasodium pyrophosphate, titanium dioxide, sodium benzoate, sodium hydroxide, sodium saccharin, trisodium phosphate, methylparaben, propylparaben

Distributed by:

United Exchange Corp.

17211 Valley View Ave.

Cerritos, CA 90703

10105

IODENT SENSITIVE EXTRA WHITENING 
sodium fluoride potassium nitrate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-105
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION5 mg  in 1 g
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE2.43 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SORBITOL (UNII: 506T60A25R)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65923-105-041 in 1 CARTON12/21/2016
1113 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35610/23/201409/14/2021
Labeler - United Exchange Corp. (840130579)

Revised: 11/2021
 
United Exchange Corp.