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Colgate Total Whitening by Colgate-Palmolive

Dosage form: paste, dentifrice
Ingredients: Sodium Fluoride 1.4mg in 1g, Triclosan 3mg in 1g
Labeler: Colgate-Palmolive
NDC Code: 35000-002

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:

  • 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 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
COLGATE TOTAL WHITENING 
sodium fluoride and triclosan paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35000-002
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium Fluoride (Fluoride Ion) Fluoride Ion1.4 mg  in 1 g
Triclosan (Triclosan) Triclosan3 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Water 
Hydrated Silica 
Glycerin 
Sorbitol 
Butyl Ester of Methyl Vinyl Ether/Maleic Anhydride Copolymer (125000 MW) 
Sodium lauryl sulfate 
Sodium hydroxide 
Propylene Glycol 
Saccharin Sodium 
Carboxymethylcellulose Sodium, Unspecified Form 
Mica 
Titanium dioxide 
Carrageenan 
FD&C Blue No. 1 
Product Characteristics
ColorBLUE, WHITEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:35000-002-421 TUBE in 1 CARTON
1119 g in 1 TUBE
2NDC:35000-002-342 TUBE in 1 CARTON
2170 g in 1 TUBE
3NDC:35000-002-601 TUBE in 1 CARTON
3170 g in 1 TUBE
4NDC:35000-002-711 TUBE in 1 CARTON
4204 g in 1 TUBE
5NDC:35000-002-781 TUBE in 1 CARTON
5221 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02023109/20/2010
Labeler - Colgate-Palmolive (068693167)

Revised: 01/2018
 
Colgate-Palmolive

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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