COLGATE SENSITIVE SMARTFOAM WITH WHITENING- potassium nitrate and sodium fluoride 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 SMARTFOAM® WITH WHITENING

Drug Facts

Active ingredients	Purpose
Potassium nitrate 5%	Antisensitivity
Sodium fluoride 0.24% (0.15% 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 older	apply 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 years	consult a dentist or physician

Inactive ingredients

water, glycerin, hydrated silica, sorbitol, PEG-12, sodium lauryl sulfate, flavor, poloxamer 407, cocamidopropyl betaine, xanthan gum, cellulose gum, sodium saccharin, sodium hydroxide, titanium dioxide

Questions?

1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 170 g Tube Carton

Colgate®
Toothpaste for Sensitive Teeth and Cavity Protection

Clinically Proven
Sensitivity Relief

NET WT 6.0 OZ (170 g)

NEW
MAXIMUM STRENGTH**

Sensitive
SmartFoam®
WITH Whitening

30% More Foam†

✓Gets to Tough-to-Reach Spaces ✓Helps Keep Teeth Whiter*

Principal Display Panel - 170 g Tube Carton

COLGATE SENSITIVE SMARTFOAM WITH WHITENING
potassium nitrate and sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG LABEL	Item Code (Source)	NDC:65954-049
Route of Administration	DENTAL	DEA Schedule

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POTASSIUM NITRATE (NITRATE ION)	POTASSIUM NITRATE	50 mg in 1 g
SODIUM FLUORIDE (FLUORIDE ION)	FLUORIDE ION	1.1 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN	260 mg in 1 g
WATER
SORBITOL
HYDRATED SILICA
POLYETHYLENE GLYCOL 600
SODIUM LAURYL SULFATE
POLOXAMER 407
COCAMIDOPROPYL BETAINE
XANTHAN GUM
CARBOXYMETHYLCELLULOSE SODIUM
SACCHARIN SODIUM
SODIUM HYDROXIDE
TITANIUM DIOXIDE

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor	SPEARMINT	Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:65954-049-60	1 in 1 CARTON
1		170 g in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part355	05/01/2013

Labeler - Mission Hills S.A de C.V (812312122)

Revised: 4/2013

Document Id: 0c761fa8-8c99-487b-bb76-74bdb8e4dedf

Set id: 8973c159-ebc6-4d1f-b7e6-f81674bd64e7

Version: 1

Effective Time: 20130405

Mission Hills S.A de C.V