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

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Colgate® Total® Whitening Gel

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:

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 gumdisease.

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, carrageenan, propylene glycol, sodium saccharin, mica, titanium dioxide, FD&C blue no. 1

Questions or comments?

Call toll-free 1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 119 g Tube Carton

Colgate®
Anticavity Fluoride and Antigingivitis Toothpaste

Total®

ADA
Accepted
American
Dental
Association ®

WHITENING

NET WT 4.2 OZ (119 g)

HELPS REMOVE & PREVENT STAINS

CAVITIES
PLAQUE
GINGIVITIS
ENAMEL
TARTAR
BREATH
WHITENS
G l
PRINCIPAL DISPLAY PANEL - 119 g Tube Carton
COLGATE TOTAL WHITENING 
sodium fluoride and triclosan paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-002
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)  
BUTYL ESTER OF METHYL VINYL ETHER/MALEIC ANHYDRIDE COPOLYMER (125000 MW) (UNII: 389H2R62BD)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
MICA (UNII: V8A1AW0880)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CARRAGEENAN (UNII: 5C69YCD2YJ)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
ColorBLUE, WHITEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:35000-002-421 in 1 CARTON09/20/201001/01/2022
1119 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:35000-002-342 in 1 CARTON09/20/201001/01/2022
2170 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:35000-002-601 in 1 CARTON09/20/201001/01/2022
3170 g in 1 TUBE; Type 0: Not a Combination Product
4NDC:35000-002-711 in 1 CARTON09/20/201002/23/2011
4204 g in 1 TUBE; Type 0: Not a Combination Product
5NDC:35000-002-781 in 1 CARTON09/20/201001/01/2022
5221 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02023109/20/2010
Labeler - Colgate-Palmolive Company (001344381)
Establishment
NameAddressID/FEIBusiness Operations
Colgate-Palmolive785047999MANUFACTURE(35000-002)

Revised: 12/2019
Document Id: b6ac83a1-00c3-40ff-987a-abb9a4e9adc3
Set id: 7b62ffcf-a7f2-46de-ab8c-88688c984fca
Version: 7
Effective Time: 20191211
 
Colgate-Palmolive Company