COLGATE® SENSITIVE SMARTFOAM® WITH WHITENING

COLGATE SENSITIVE SMARTFOAM WITH WHITENING by

Drug Labeling and Warnings

COLGATE SENSITIVE SMARTFOAM WITH WHITENING by is a Otc medication manufactured, distributed, or labeled by Mission Hills S.A de C.V. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 ingredientsPurpose
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 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, 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

30% More Foaming Action†
✓ Clinically Proven Sensitivity Relief ✓ Gets to Tough-to-Reach Spaces

NET WT 6.0 OZ (170 g)

MAXIMUM STRENGTH*

Sensitive

SmartFoam®
WITH
whitening

Mint Fresh
paste

Principal Display Panel - 170 g Tube Carton
COLGATE SENSITIVE SMARTFOAM WITH WHITENING 
potassium nitrate and sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 65954-049
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE50 mg  in 1 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 260 mg  in 1 g
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorSPEARMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 65954-049-601 in 1 CARTON05/01/2013
1170 g in 1 TUBE; Type 0: Not a Combination Product
2NDC: 65954-049-021 in 1 CARTON05/01/2013
256 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 FINALpart35605/01/2013
Labeler - Mission Hills S.A de C.V (812312122)

Revised: 4/2019
Document Id: 0c0b4ab1-8df6-4787-afef-a09811654781
Set id: 8973c159-ebc6-4d1f-b7e6-f81674bd64e7
Version: 3
Effective Time: 20190415
 
Mission Hills S.A de C.V