COLGATE  TOTAL ADVANCED FRESH PLUS WHITENING- sodium fluoride and triclosan paste, dentifrice 
Colgate-Palmolive

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Colgate® Total® Advanced Fresh plus Whitening

Drug Facts

Active ingredientsPurpose
Sodium fluoride 0.24% (0.15% 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, flavor, PVM/MA copolymer, sodium lauryl sulfate, cellulose gum, sodium hydroxide, propylene glycol, carrageenan, sodium saccharin, mica, titanium dioxide, FD&C blue no. 1, D&C yellow no. 10

Questions or comments?

Call toll-free 1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 21.2 g Tube Carton

NEW

Colgate®
Anticavity Fluoride and Antigingivitis Toothpaste

Total®

ADA
Accepted
American
Dental
Association ®

FRESH+WHITENING FRESHENS BREATH FOR 12 HOURS & WHITENS TEETH
ADVANCED

NET WT 0.75 OZ (21.2 g)
Helps Prevent: Cavities • Gingivitis • Plaque | Fights Tartar • Freshens Breath • Whitens
Fresh Gel

PRINCIPAL DISPLAY PANEL - 21.2 g Tube Carton
COLGATE   TOTAL ADVANCED FRESH PLUS WHITENING
sodium fluoride and triclosan paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-570
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (UNII: 8ZYQ1474W7) (Fluoride Ion - UNII:Q80VPU408O) Fluoride Ion1.5 mg  in 1 g
Triclosan (UNII: 4NM5039Y5X) (Triclosan - UNII:4NM5039Y5X) Triclosan3 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Sorbitol (UNII: 506T60A25R)  
Butyl Ester Of Methyl Vinyl Ether/Maleic Anhydride Copolymer (125000 MW) (UNII: 389H2R62BD)  
Sodium Lauryl Sulfate (UNII: 368GB5141J)  
Carboxymethylcellulose Sodium, unspecified form (UNII: K679OBS311)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Carrageenan (UNII: 5C69YCD2YJ)  
FD&C blue No. 1 (UNII: H3R47K3TBD)  
D&C yellow No. 10 (UNII: 35SW5USQ3G)  
Saccharin Sodium (UNII: SB8ZUX40TY)  
Hydrated Silica (UNII: Y6O7T4G8P9)  
Mica (UNII: V8A1AW0880)  
Product Characteristics
ColorGREENScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:35000-570-161 in 1 CARTON08/12/201108/01/2019
121.2 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:35000-570-691 in 1 CARTON08/12/201108/01/2019
2113 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:35000-570-661 in 1 CARTON08/12/201108/01/2019
3164 g in 1 TUBE; Type 0: Not a Combination Product
4NDC:35000-570-481 in 1 CARTON08/12/201108/01/2019
4226 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02023108/12/201108/01/2019
Labeler - Colgate-Palmolive (068693167)

Revised: 9/2019
Document Id: 60be9e53-a4c9-47b3-b760-0005ea3c774d
Set id: 326cec20-b0e0-42c8-b026-80bcc996f86d
Version: 3
Effective Time: 20190906
 
Colgate-Palmolive