COLGATE  TOTAL WHITENING- sodium fluoride and triclosan paste, dentifrice 
Colgate-Palmolive Company

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Colgate®
Total®
Whitening Paste

Drug Facts

Active ingredientsPurpose
Sodium fluoride 0.24% (0.14% w/v fluoride ion)Anticavity
Triclosan 0.30%Antigingivitis

Uses

aids in the prevention of:

  • cavities
  • plaque
  • gingivitis

Warnings

Keep out of the reach of children under 6 years of age.

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Ask a dentist before use if you have

  • bleeding or redness lasting more than 2 weeks
  • pain, swelling, pus, loose teeth, or more spacing between teeth

These may be signs of periodontitis, a serious form of gum disease.

Directions

supervise children as necessary until capable of using without supervision.

adults and children 6 years of age and olderbrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or a physician
children under 12 yearsinstruct in good brushing and rinsing habits
(to minimize swallowing)
children under 6 yearsdo not use unless directed by a dentist or a physician

Antiplaque and antigingivitis use not proven in children.

Inactive ingredients

water, hydrated silica, glycerin, sorbitol, PVM/MA copolymer, sodium lauryl sulfate, cellulose gum, flavor, sodium hydroxide, propylene glycol, carrageenan, sodium saccharin, titanium dioxide

Questions or comments?

Call toll-free 1-800-468-6502

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

www.colgatetotal.com

PRINCIPAL DISPLAY PANEL - 170 g Tube Carton

NEW
STAND-UP
CAP

Helps Prevent Cavities • Gingivitis • Plaque
Fights Tartar Buildup • Whitens

Colgate®
Anticavitiy Fluoride and Antigingivitis Toothpaste

Total®
Whitening Paste

ADA
Accepted
American
Dental
Association ®

NET WT 6.0 OZ (170 g)

Principal Display Panel - 170 g Tube Carton
COLGATE   TOTAL WHITENING
sodium fluoride and triclosan paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-003
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.4 mg  in 1 g
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN3 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
GLYCERIN (UNII: PDC6A3C0OX)  
SORBITOL (UNII: 506T60A25R)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:35000-003-342 in 1 CARTON12/14/201001/01/2022
1170 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:35000-003-851 in 1 CARTON02/08/201112/09/2011
2204 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:35000-003-711 in 1 CARTON10/21/201001/01/2022
3119 g in 1 TUBE; Type 0: Not a Combination Product
4NDC:35000-003-601 in 1 CARTON09/28/201001/01/2022
4170 g in 1 TUBE; Type 0: Not a Combination Product
5NDC:35000-003-781 in 1 CARTON10/21/201001/01/2022
5221 g in 1 TUBE; Type 0: Not a Combination Product
6NDC:35000-003-991 in 1 CARTON10/21/201001/01/2022
621 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02023108/10/201001/08/2022
Labeler - Colgate-Palmolive Company (001344381)
Establishment
NameAddressID/FEIBusiness Operations
Colgate-Palmolive785047999MANUFACTURE(35000-003)

Revised: 12/2019
Document Id: 5d9a1343-ce85-4d29-b54e-0cc6c82d6eb7
Set id: d7137335-1c85-4d7a-adae-72ff8d63f571
Version: 9
Effective Time: 20191211
 
Colgate-Palmolive Company