UNIVERSAL SENSITIVE ANTI-CAVITY FLUORIDE- potassium nitrate and sodium fluoride paste 
Universal Distribution Center LLC

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UNIVERSAL SENSITIVE ANTI-CAVITY FLUORIDE TOOTHPASTE

Active Ingredients

Potassium Nitrate  5%

Sodium Fluoride- 0.32% (0.15% w/v fluoride ion)

Purpose

Antihypersensitivity

Anticavity

Uses

Warning

When using this product

Stop and ask a dentist

Sensitivity teeth may indicate a serious problem that may need prompt care by a dentist.

Keep out of reach of children

Directions

Children under 12 years of age: Consult a dentist or doctor.

Other information

Inactive Ingredients

Sorbitol, Water, Silica, Sodium lauryl sulfate, Xanthan gum, Sodium saccharin, Sodium benzoate, Sodium carboxy methyl cellulose, Titanium dioxide, Flavor, D&C yellow#10, FD&C blue#1

PRINCIPAL DISPLAY PANEL

UNIVERSAL SENSITIVE ANTI-CAVITY FLUORIDE TOOTHPASTE

label

UNIVERSAL SENSITIVE ANTI-CAVITY FLUORIDE 
potassium nitrate and sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-109
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE5 g  in 100 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.15 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
XANTHAN GUM (UNII: TTV12P4NEE)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52000-109-01122 g in 1 TUBE; Type 0: Not a Combination Product05/20/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02205/20/2020
Labeler - Universal Distribution Center LLC (019180459)

Revised: 11/2023
Document Id: 1199f2f8-98e4-4b76-9be9-3b921495a3c3
Set id: fcf59439-7e06-4129-a89f-cdeecdf8d488
Version: 2
Effective Time: 20231117
 
Universal Distribution Center LLC