COLGATE SENSITIVE WHITENING FRESH MINT- potassium nitrate and sodium fluoride gel, 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.

----------

COLGATE® SENSITIVE WHITENING FRESH MINT 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, PVM/MA copolymer, sodium lauryl sulfate, flavor, poloxamer 407, trisodium phosphate, sodium hydroxide, cellulose gum, sodium saccharin, xanthan gum, titanium dioxide, FD&C blue no. 1

Questions?

1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 170 g Tube Carton

MAXIMUM STRENGTH*

Colgate®
Anticavity Toothpaste for Sensitive Teeth

Sensitive

WHITENING

RELIEVES & WHITENS

CLINICALLY PROVEN SENSITIVITY RELIEF
SUPERIOR STAIN REMOVAL

Recyclable
Tube

NET WT 6.0 OZ (170 g)
FRESH MINT
gel

PRINCIPAL DISPLAY PANEL - 170 g Tube Carton
COLGATE SENSITIVE WHITENING FRESH MINT 
potassium nitrate and sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-922
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
WATER (UNII: 059QF0KO0R) 202.62 mg  in 1 g
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
GLYCERIN (UNII: PDC6A3C0OX)  
SORBITOL (UNII: 506T60A25R)  
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
BUTYL ESTER OF METHYL VINYL ETHER/MALEIC ANHYDRIDE COPOLYMER (125000 MW) (UNII: 389H2R62BD)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
PHOSPHATE ION (UNII: NK08V8K8HR)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
XANTHAN GUM (UNII: TTV12P4NEE)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
ColorWHITE, BLUEScore    
ShapeSize
FlavorSPEARMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:35000-922-181 in 1 CARTON10/16/2015
151 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:35000-922-601 in 1 CARTON10/16/2015
2170 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:35000-922-461 in 1 CARTON01/07/2019
3130 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 FINALpart35610/16/2015
Labeler - Colgate-Palmolive Company (001344381)

Revised: 1/2022
Document Id: 53ea6b73-2d40-4419-8ec6-fbe37a3ea3e4
Set id: e3c72df4-5c59-4cb6-a63c-d63713fb4de3
Version: 4
Effective Time: 20220120
 
Colgate-Palmolive Company