COLGATE SENSITIVE MAXIMUM STRENGTH WHITENING- sodium fluoride and potassium nitrate paste, dentifrice 
Colgate-Palmolive Company

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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Drug Facts

Active ingredients

Potassium nitrate 5%

Sodium fluoride 0.24% (0.15% w/v fluoride ion)

Purpose

Antisensitivity

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, do not use longer than 4 weeks unless recommended by a dentist or physician.

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 the 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 a physician

Inactive ingredients

water, glycerin, hydrated silica, sorbitol, PEG-12, sodium lauryl sulfate, flavor, poloxamer 407, xanthan gum, cellulose gum, sodium saccharin, sodium hydroxide, titanium dioxide, FD&C blue no. 1

Questions or comments?

Call toll-free 1-800-468-6502

Dist. by:
COLGATE-PALMOLIVE COMPANY
New York, NY 10022
Made in Mexico
www.colgatesensitive.com

PRINCIPAL DISPLAY PANEL - 4.0 OZ Tube

Specially Formulated for Sensitive Teeth

Colgate®
Toothpaste for Sensitive Teeth and Cavity Protection

MAXIMUM STRENGTH
Sensitive
WHITENING

NET WT 4.0 OZ (113 g)

✓Fast Relief ✓Proven Protection ✓Removes Stains

Principle Display Panel - 4.0 OZ Tube

PRINCIPAL DISPLAY PANEL - 4.0 OZ carton

Specially Formulated for Sensitive Teeth

Colgate®
Toothpaste for Sensitive Teeth and Cavity Protection

MAXIMUM STRENGTH
Sensitive
WHITENING

NET WT 4.0 OZ (113 g)

✓Fast Relief ✓Proven Protection ✓Removes Stains

Principle Display Panel - 4.0 OZ carton
COLGATE  SENSITIVE MAXIMUM STRENGTH WHITENING
sodium fluoride and potassium nitrate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65954-358
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) SODIUM FLUORIDE2.4 mg  in 1 g
POTASSIUM NITRATE (POTASSIUM CATION) POTASSIUM NITRATE50 mg  in 1 g
Product Characteristics
ColorBLUE, WHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:65954-358-691 in 1 CARTON
1113 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35507/07/2009
Labeler - Colgate-Palmolive Company (812312122)

Revised: 07/2009
Document Id: 71f0555c-9457-419e-b872-723f7374d0df
Set id: 6dbe7f01-6c00-40a0-a8b1-3225aae96626
Version: 1
Effective Time: 20090713
 
Colgate-Palmolive Company