COLGATE SENSITIVE COMPLETE PROTECTION- 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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Colgate® Sensitive Complete Protection Toothpaste

Drug Facts

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

Uses

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, tetrapotassium pyrophosphate, PVM/MA copolymer, flavor, sodium lauryl sulfate, poloxamer 407, sodium hydroxide, sodium saccharin, cellulose gum, xanthan gum, 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

8 Benefits

✓Sensitivity    ✓Tartar    ✓Freshens
✓Enamel      ✓Plaque** ✓Whitens
✓Cavities    ✓Gums**

NET WT 6.0 OZ (170 g)

NEW
MAXIMUM STRENGTH*

Sensitive

Complete Protection

Principal Display Panel - 170 g Tube Carton
COLGATE SENSITIVE COMPLETE PROTECTION 
sodium fluoride and potassium nitrate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-965
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
WATER (UNII: 059QF0KO0R) 189.046 mg  in 1 g
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
GLYCERIN (UNII: PDC6A3C0OX)  
SORBITOL (UNII: 506T60A25R)  
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)  
BUTYL ESTER OF METHYL VINYL ETHER/MALEIC ANHYDRIDE COPOLYMER (125000 MW) (UNII: 389H2R62BD)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
XANTHAN GUM (UNII: TTV12P4NEE)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:35000-965-601 in 1 CARTON12/18/2013
1170 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:35000-965-691 in 1 CARTON12/18/2013
2113 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:35000-965-011 in 1 CARTON12/18/2013
328.3 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 FINALpart35612/18/2013
Labeler - Colgate-Palmolive Company (001344381)

Revised: 12/2019
Document Id: 5de6601e-26e3-4b83-a211-762ebf2b8374
Set id: 0e2ae43e-54a8-41fd-828b-448623c631f1
Version: 1
Effective Time: 20191218
 
Colgate-Palmolive Company