COLGATE SENSITIVE PRO RELIEF ENAMEL REPAIR- 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™ Enamel Repair Fluoride Toothpaste

Drug Facts

Active ingredientsPurpose
Potassium nitrate 5%Antisensitivity
Sodium monofluorophosphate 1.14% (0.19% 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 technology

NET WT 4.0 OZ (113 g)
ENAMEL REPAIR
Gentle Mint

Principal Display Panel - 113 g Tube Carton
COLGATE SENSITIVE PRO RELIEF ENAMEL REPAIR 
sodium fluoride and potassium nitrate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:65954-553
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION1.5 mg  in 1 g
POTASSIUM NITRATE (NITRATE ION) POTASSIUM NITRATE50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
HYDRATED SILICA16 mg  in 1 g
WATER 
SORBITOL 
GLYCERIN 
POLYETHYLENE GLYCOL 600 
SODIUM PYROPHOSPHATE 
SILICON DIOXIDE 
SODIUM LAURYL SULFATE 
POLOXAMER 407 
SODIUM PHOSPHATE, TRIBASIC, MONOHYDRATE 
SODIUM HYDROXIDE 
CARBOXYMETHYLCELLULOSE SODIUM 
SACCHARIN SODIUM 
XANTHAN GUM 
TITANIUM DIOXIDE 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65954-553-011 in 1 CARTON
128.3 g in 1 TUBE
2NDC:65954-553-691 in 1 CARTON
2113 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35501/12/2011
Labeler - Mission Hills S.A de C.V (812312122)

Revised: 1/2013
Document Id: 75eb3dfd-1b20-4862-b0a3-0a789bab9b22
Set id: d755fd05-baac-4819-9f69-dbf63675010e
Version: 1
Effective Time: 20130131
 
Mission Hills S.A de C.V