Your browser does not support JavaScript! COLGATE TOTAL ADVANCED FRESH PLUS WHITENING (SODIUM FLUORIDE AND TRICLOSAN) PASTE, DENTIFRICE [COLGATE-PALMOLIVE]
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COLGATE TOTAL ADVANCED FRESH PLUS WHITENING (sodium fluoride and triclosan) paste, dentifrice
[Colgate-Palmolive]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL New Drug Application
Drug Label Sections

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 AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (Fluoride Ion) Fluoride Ion1.5 mg  in 1 g
Triclosan (Triclosan) Triclosan3 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Water 
Sorbitol 
Butyl Ester Of Methyl Vinyl Ether/Maleic Anhydride Copolymer (125000 MW) 
Sodium Lauryl Sulfate 
Carboxymethylcellulose Sodium 
Sodium Hydroxide 
Propylene Glycol 
Carrageenan 
FD&C blue No. 1 
D&C yellow No. 10 
Saccharin Sodium 
Hydrated Silica 
Mica 
Product Characteristics
ColorGREENScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:35000-570-161 in 1 CARTON
121.2 g in 1 TUBE
2NDC:35000-570-691 in 1 CARTON
2113 g in 1 TUBE
3NDC:35000-570-661 in 1 CARTON
3164 g in 1 TUBE
4NDC:35000-570-481 in 1 CARTON
4226 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02023108/12/2011
Labeler - Colgate-Palmolive (068693167)

Revised: 01/2013
Document Id: 7d421673-3c8f-4fd6-9aae-db663d21981a
Set id: 326cec20-b0e0-42c8-b026-80bcc996f86d
Version: 2
Effective Time: 20130103
 
Colgate-Palmolive

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