COLGATE SENSITIVE PRO RELIEF- sodium fluoride and potassium nitrate paste, dentifrice 
Mission Hills S.A de C.V

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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Colgate® Sensitive Pro Relief™ Base 4.0oz Fluoride Toothpaste

Drug Facts

Active ingredientsPurpose
Potassium nitrate 5%Antisensitivity
Sodium fluoride 0.24% (0.14% w/v fluoride ion)Anticavity

Uses

  • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
  • helps protect against cavities

Warnings

When using this product, if pain/sensitivity still persists after 4 weeks of use, please visit your dentist.

Stop use and ask a dentist if the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

Keep out of reach of children. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults and children 12 years of age and olderapply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening) or as recommended by a dentist or physician. Make sure to brush all sensitive areas of the teeth.
children under 12 yearsconsult a dentist or physician

Inactive ingredients

water, hydrated silica, glycerin, sorbitol, PEG-12, PVM/MA copolymer, sodium lauryl sulfate, flavor, poloxamer 407, trisodium phosphate, sodium hydroxide, cellulose gum, sodium saccharin, xanthan gum, titanium dioxide

Questions?

1-800-468-6502

Dist by:
COLGATE-PALMOLIVE COMPANY
New York, NY 10022

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

Colgate®
Fluoride Toothpaste for Sensitive Teeth

24/7
Protection*

Sensitive Pro-Relief™

CLINICALLY PROVEN sensitivity relief

NET WT 4.0 OZ (113 g)

Fresh Mint

PRINCIPAL DISPLAY PANEL - 113 g Tube Carton
COLGATE SENSITIVE PRO RELIEF 
sodium fluoride and potassium nitrate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65954-549
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE2.4 mg  in 1 g
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
HYDRATED SILICA (UNII: Y6O7T4G8P9) 180 mg  in 1 g
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
SORBITOL (UNII: 506T60A25R)  
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
BUTYL ESTER OF METHYL VINYL ETHER/MALEIC ANHYDRIDE COPOLYMER (125000 MW) (UNII: 389H2R62BD)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
PHOSPHATE ION (UNII: NK08V8K8HR)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
XANTHAN GUM (UNII: TTV12P4NEE)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorSPEARMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65954-549-691 in 1 CARTON09/06/2010
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 FINALpart35609/06/2010
Labeler - Mission Hills S.A de C.V (812312122)

Revised: 8/2019
Document Id: 8d158b50-0426-4956-a9be-24e405c0c261
Set id: f6d2051c-c4ad-4c56-8d4e-31331bc328e7
Version: 4
Effective Time: 20190830
 
Mission Hills S.A de C.V